Nitrous oxide EUROPEAN PHARMACOPOEIA 5.0 Carbon monoxide Gas chromatography (2.2.28) When the test is carried out on a cylinder, use the first portion of gas to be withdrawn Gas to be examined The substance to be examined Reference gas A mixture containing ppm V/V of carbon IMPURITIES monoxide R in nitrous oxide R Column : A oxygen, — material : stainless steel, B argon — size : l = m, Ø = mm, — stationary phase : suitable molecular sieve for chromatography (0.5 nm) 01/2005:0416 Carrier gas : helium for chromatography R NITROUS OXIDE Flow rate : 60 ml/min Temperature : Dinitrogenii oxidum — column : 50 °C, — injection port and detector : 130 °C N 2O Mr 44.01 Detection : flame ionisation with methaniser Injection : loop injector DEFINITION Content : minimum 98.0 per cent V/V of N2O in the gaseous Adjust the injected volumes and the operating conditions so that the height of the peak due to carbon monoxide in the phase, when sampled at 15 °C chromatogram obtained with the reference gas is at least This monograph applies to nitrous oxide for medicinal use 35 per cent of the full scale of the recorder Limit : CHARACTERS — carbon monoxide : not more than the area of the Appearance : colourless gas corresponding peak in the chromatogram obtained with Solubility : at 20 °C and at a pressure of 101 kPa, volume the reference gas (5 ppm V/V) dissolves in about 1.5 volumes of water Nitrogen monoxide and nitrogen dioxide : maximum PRODUCTION ppm V/V in total in the gaseous and liquid phases, determined using a chemiluminescence analyser (2.5.26) Nitrous oxide is produced from ammonium nitrate by Gas to be examined The substance to be examined thermic decomposition Reference gas (a) Nitrous oxide R Examine the gaseous phase If the test is performed on a cylinder, keep the cylinder at Reference gas (b) A mixture containing ppm V/V of nitrogen monoxide R in nitrogen R1 room temperature for at least h before carrying out the tests Keep the cylinder in the vertical position with the Calibrate the apparatus and set the sensitivity using outlet valve uppermost reference gases (a) and (b) Measure the content of nitrogen monoxide and nitrogen dioxide, separately examining the Carbon dioxide Gas chromatography (2.2.28) samples collected from the gaseous phase and the liquid Gas to be examined The substance to be examined phase of the gas to be examined Reference gas A mixture containing 300 ppm V/V of carbon Multiply the result obtained by the quenching correction dioxide R1 in nitrous oxide R factor in order to correct the quenching effect on the Column : analyser response caused by the nitrous oxide matrix effect — material : stainless steel, The quenching correction factor is determined by applying a known reference mixture of nitrogen monoxide in nitrous — size : l = 3.5 m, Ø = mm, oxide and comparing the actual content with the content — stationary phase: ethylvinylbenzene-divinylbenzene indicated by the analyser which has been calibrated with copolymer R a NO/N2 reference mixture Carrier gas : helium for chromatography R = Flow rate : 15 ml/min Temperature : Water : maximum 67 ppm V/V, determined using an — column : 40 °C, electrolytic hygrometer (2.5.28) — detector : 90 °C Assay Gas chromatography (2.2.28) Detection : thermal conductivity Gas to be examined The substance to be examined Injection : loop injector Reference gas Nitrous oxide R Adjust the injected volumes and operating conditions so Column : that the height of the peak due to carbon dioxide in the — material : stainless steel, chromatogram obtained with the reference gas is at least — size : l = m, Ø = mm, 35 per cent of the full scale of the recorder The test is — stationary phase : silica gel for chromatography R not valid unless the chromatograms obtained show a clear (250-355 µm) separation of carbon dioxide from nitrous oxide Carrier gas : helium for chromatography R Limit : Flow rate : 50 ml/min — carbon dioxide : not more than the area of the Temperature : corresponding peak in the chromatogram obtained with — column and injection port : 60 °C, the reference gas (300 ppm V/V) STORAGE Where the gas has to be stored, store as a compressed gas or a liquid in appropriate containers complying with the legal regulations 2110 See the information section on general monographs (cover pages) Nizatidine EUROPEAN PHARMACOPOEIA 5.0 01/2005:1453 — detector : 130 °C Detection : thermal conductivity NIZATIDINE Injection : loop injector Adjust the injected volumes and the operating conditions so that the height of the peak due to nitrous oxide in the chromatogram obtained with the reference gas is at least 35 per cent of the full scale of the recorder Nizatidinum The area of the peak due to nitrous oxide in the chromatogram obtained with the gas to be examined is at least 98.0 per cent of the area of the peak due to nitrous oxide in the chromatogram obtained with the reference gas IDENTIFICATION First identification : A Second identification : B, C A Infrared absorption spectrophotometry (2.2.24) Comparison : Ph Eur reference spectrum of nitrous oxide B Place a glowing splinter of wood in the substance to be examined The splinter bursts into flame C Introduce the substance to be examined into alkaline pyrogallol solution R A brown colour does not develop TESTS Examine the gaseous phase If the test is performed on a cylinder, keep the cylinder of the substance to be examined at room temperature for at least h before carrying out the tests Keep the cylinder in the vertical position with the outlet valve uppermost Carbon dioxide : maximum 300 ppm V/V, determined using a carbon dioxide detector tube (2.1.6) Carbon monoxide : maximum ppm V/V, determined using a carbon monoxide detector tube (2.1.6) When the test is carried out on a cylinder, use the first portion of the gas to be withdrawn Nitrogen monoxide and nitrogen dioxide : maximum ppm V/V, determined using a nitrogen monoxide and nitrogen dioxide detector tube (2.1.6) Water vapour : maximum 67 ppm V/V, determined using a water vapour detector tube (2.1.6) STORAGE Store liquefied under pressure in suitable containers complying with the legal regulations The taps and valves are not greased or oiled IMPURITIES A carbon dioxide, B carbon monoxide, C nitrogen monoxide, D nitrogen dioxide, E water General Notices (1) apply to all monographs and other texts C12H21N5O2S2 Mr 331.5 DEFINITION Nizatidine contains not less than 97.0 per cent and not more than the equivalent of 101.0 per cent of (EZ)-N-[2-[[[2[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]N′-methyl-2-nitroethene-1,1-diamine, calculated with reference to the dried substance CHARACTERS An almost white or slightly brownish, crystalline powder, sparingly soluble in water, soluble in methanol IDENTIFICATION First identification : C Second identification : A, B, D A Melting point (2.2.14) : 131 °C to 134 °C B Dissolve 0.10 g of the substance to be examined in methanol R and dilute to 100.0 ml with the same solvent Dilute 2.0 ml of the solution to 100.0 ml with methanol R Examined between 220 nm and 350 nm (2.2.25), the solution shows two absorption maxima, at 242 nm and 325 nm The ratio of the absorbance measured at the maximum at 325 nm to that measured at the maximum at 242 nm is 2.2 to 2.5 C Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with nizatidine CRS Examine the substance prepared as discs D Examine by thin-layer chromatography (2.2.27), using a TLC silica gel plate R Test solution Dissolve 50 mg of the substance to be examined in methanol R and dilute to 10 ml with the same solvent Reference solution (a) Dissolve 50 mg of nizatidine CRS in methanol R and dilute to 10 ml with the same solvent Reference solution (b) Dissolve 50 mg of nizatidine CRS and 50 mg of ranitidine hydrochloride CRS in methanol R and dilute to 10 ml with the same solvent Apply to the plate µl of each solution Develop over a path corresponding to two thirds of the height of the plate using a mixture of volumes of water R, volumes of concentrated ammonia R1, 15 volumes of 2-propanol R and 25 volumes of ethyl acetate R Allow the plate to dry in air and expose to iodine vapour until the spots are clearly visible Examine in daylight The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a) The test is not valid unless the chromatogram obtained with reference solution (b) shows two clearly separated spots 2111 Nizatidine EUROPEAN PHARMACOPOEIA 5.0 TESTS Appearance of solution Dissolve 0.2 g of the substance to be examined in a 10 g/l solution of hydrochloric acid R and dilute to 20 ml with the same acid solution The solution is clear (2.2.1) and not more intensely coloured than reference solution Y5 (2.2.2, Method II) pH (2.2.3) Dissolve 0.2 g of the substance to be examined in carbon dioxide-free water R and dilute to 20 ml with the same solvent The pH of the solution is 8.5 to 10.0 Related substances Examine by liquid chromatography (2.2.29) as described under Assay, replacing the mixture of mobile phases by the following elution programme : Reference solution (a) Dilute 1.0 ml of test solution (a) to 100.0 ml with a mixture of 24 volumes of mobile phase B and 76 volumes of mobile phase A Reference solution (b) Dissolve 15.0 mg of nizatidine CRS in a mixture of 24 volumes of mobile phase B and 76 volumes of mobile phase A and dilute to 50.0 ml with the same mixture of mobile phases Reference solution (c) Dissolve mg of nizatidine CRS and 0.5 mg of nizatidine impurity F CRS in a mixture of 24 volumes of mobile phase B and 76 volumes of mobile phase A and dilute to 100.0 ml with the same mixture of mobile phases The chromatographic procedure may be carried out using : Time (min) Mobile phase A (per cent V/V) Comment Mobile phase B (per cent V/V) — a stainless steel column 0.25 m long and 4.6 mm in internal diameter packed with octadecylsilyl silica gel for chromatography R (5 µm), 0-3 76 24 isocratic - 20 76 → 50 24 → 50 linear gradient 20 - 45 50 50 isocratic 45 - 50 50 → 76 50 → 24 linear gradient 50 - 60 76 24 re-equilibration Inject 20 µl of reference solution (a) Adjust the sensitivity of the system so that the height of the principal peak in the chromatogram obtained with the reference solution is at least 50 per cent of the full scale of the recorder The test is not valid unless the retention time of nizatidine is between 10 and 20 and the symmetry factor of the peak due to nizatidine is not greater than 2.0 Inject 20 µl of reference solution (c) The test is not valid unless the resolution between the peak due to nizatidine (first peak) and impurity F (second peak) is at least 2.0 Inject 20 µl of test solution (a) In the chromatogram obtained, the area of any peak apart from the principal peak, is not greater than 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.3 per cent) and the sum of the areas of all these peaks is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (1.5 per cent) Disregard any peak with an area less than 0.03 times the area of the principal peak in the chromatogram obtained with reference solution (a) — as mobile phase at a flow rate of 1.0 ml/min a mixture of 35 volumes of mobile phase B and 65 volumes of mobile phase A : Mobile phase A Dissolve 5.9 g of ammonium acetate R in 760 ml of water R, add ml of diethylamine R, and adjust the pH to 7.5 with acetic acid R, Mobile phase B Methanol R, — as detector a spectrophotometer set at 254 nm Inject 20 µl of reference solution (b) The test is not valid unless the retention time of nizatidine is between and 10 and the symmetry of the peak due to nizatidine is not greater than 2.0 Inject reference solution (b) six times The test is not valid unless the relative standard deviation of the peak area for nizatidine is at most 2.0 per cent Inject 20 µl of test solution (b) and 20 µl of reference solution (b) Calculate the percentage content of nizatidine from the areas of the peaks and the declared content of nizatidine CRS IMPURITIES Heavy metals (2.4.8) 1.0 g complies with limit test C for heavy metals (20 ppm) Prepare the standard using ml of lead standard solution (10 ppm Pb) R Loss on drying (2.2.32) Not more than 0.5 per cent, determined on 1.000 g by drying in an oven at 100 °C to 105 °C Sulphated ash (2.4.14) Not more than 0.1 per cent, determined on 1.0 g A X = NH : N,N′-dimethyl-2-nitroethene-1,1-diamine, B X = S :(EZ)-N-methyl-1-(methylsulphanyl)-2-nitroethen-1amine, ASSAY Examine by liquid chromatography (2.2.29) Test solution (a) Dissolve 50.0 mg of the substance to be examined in a mixture of 24 volumes of mobile phase B and 76 volumes of mobile phase A and dilute to 10.0 ml with the same mixture of mobile phases Test solution (b) Dissolve 15.0 mg of the substance to be examined in a mixture of 24 volumes of mobile phase B and C (EZ)-N-[2-[[[2-[(dimethylamino)methyl]thiazol-476 volumes of mobile phase A and dilute to 50.0 ml with the yl]methyl]sulphinyl]ethyl]-N′-methyl-2-nitroethene-1,1same mixture of mobile phases diamine, 2112 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.0 Nomegestrol acetate DEFINITION Nomegestrol acetate contains not less than 97.0 per cent and not more than the equivalent of 103.0 per cent of 6-methyl-3,20-dioxo-19-norpregna-4,6-dien-17-yl acetate, calculated with reference to the dried substance D R = S-CH2-CH2-NH2 : 2-[[[2-[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethanamine, E R = S-CH2-CH2-NH-CO-CH2-NO2 :N-[2-[[[2-[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide, I R = S-CH2-CH2-NH-CO-NH-CH3 :N-[2-[[[2-[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-N′-methylurea, CHARACTERS A white or almost white, crystalline powder, practically insoluble in water, freely soluble in acetone, soluble in alcohol IDENTIFICATION Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with nomegestrol acetate CRS J R = OH : [2-[(dimethylamino)methyl]thiazol-4-yl]methanol, TESTS Appearance of solution Dissolve 1.0 g in methylene chloride R and dilute to 10 ml with the same solvent The solution is clear (2.2.1) and not more intensely coloured than reference solution Y5 (2.2.2, Method II) Specific optical rotation (2.2.7) Dissolve 0.500 g in ethanol R and dilute to 25.0 ml with the same solvent The 1 F (EZ)-N ,N ′-[thiazole-2,4-diylbis(methylenesulphanediylspecific optical rotation is − 60.0 to − 64.0, calculated with ethylene)]bis(N′-methyl-2-nitroethene-1,1-diamine), reference to the dried substance Related substances Examine by liquid chromatography (2.2.29) Test solution Dissolve 25.0 mg of the substance to be examined in methanol R and dilute to 50.0 ml with the same solvent Reference solution (a) Dilute 1.0 ml of the test solution to 200.0 ml with the mobile phase Reference solution (b) Dissolve 25.0 mg of nomegestrol G N,N′-bis[2-[[[2-[(dimethylamino)methyl]thiazol-4acetate impurity A CRS in methanol R and dilute to 50.0 ml yl]methyl]sulphanyl]ethyl]-2-nitroethene-1,1-diamine, with the same solvent Reference solution (c) Dissolve 25.0 mg of nomegestrol acetate CRS in 20 ml of methanol R, add 0.25 ml of reference solution (b) and dilute to 50.0 ml with the mobile phase The chromatographic procedure may be carried out using : H 2-(dimethylamino)thioacetamide, — a stainless steel column 0.25 m long and 4.6 mm in internal diameter packed with octadecylsilyl silica gel for chromatography R (5 µm), — as mobile phase at a flow rate of 1.3 ml/min a mixture of 24 volumes of acetonitrile R, 38 volumes of methanol R and 38 volumes of water R, K 3-(methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one oxime — as detector, a variable wavelength spectrophotometer capable of operating at 245 nm and at 290 nm 01/2005:1551 Inject 10 µl of reference solution (c) and record the chromatogram with the detector set at 245 nm When the chromatogram is recorded in the prescribed NOMEGESTROL ACETATE conditions, the retention times are : nomegestrol acetate about 17 and impurity A about 18.5 Adjust the Nomegestroli acetas sensitivity of the system at 245 nm so that the height of the peak due to impurity A in the chromatogram obtained with reference solution (c) is at least 50 per cent of the full scale of the recorder Measure the height Hp above the baseline of the peak due to impurity A and the height Hv above the baseline of the lowest point of the curve separating this peak from the peak due to nomegestrol acetate The test is not valid unless Hp is greater than times Hv Inject 10 µl of reference solution (a) and record the chromatogram with the detector set at 290 nm Adjust the C23H30O4 Mr 370.5 sensitivity of the system at 290 nm so that the height of the General Notices (1) apply to all monographs and other texts 2113 Nonoxinol EUROPEAN PHARMACOPOEIA 5.0 principal peak in the chromatogram obtained with reference solution (a) is at least 50 per cent of the full scale of the recorder Inject 10 µl of the test solution and record the chromatograms at 245 nm and 290 nm for 1.5 times the retention time of the principal peak In the chromatogram obtained with the test solution at 290 nm : the area of any peak, apart from the principal peak, is not greater than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 per cent) Disregard any peak with an area less than 0.04 times that of the principal peak in the chromatogram obtained with reference solution (a) (0.02 per cent) In the chromatogram obtained with the test solution at 245 nm : the area of any peak corresponding to impurity A is not greater than 0.4 times the area of the peak due to impurity A in the chromatogram obtained with reference solution (c) (0.2 per cent) ; the area of any peak, apart from the principal peak and any peak corresponding to impurity A, is not greater than 0.2 times the area of the peak due to impurity A in the chromatogram obtained with reference solution (c) (0.1 per cent) Disregard any peak with an area less than 0.1 times that of the peak due to impurity A in the chromatogram obtained with reference solution (c) (0.05 per cent) In the chromatograms obtained at 290 nm and 245 nm, the sum of the related substances apart from impurity A is not greater than 0.3 per cent Loss on drying (2.2.32) Not more than 0.5 per cent, determined on 1.000 g by drying in an oven at 100-105 °C ASSAY Dissolve 50.0 mg in ethanol R and dilute to 100.0 ml with the same solvent Dilute 2.0 ml of the solution to 100.0 ml with ethanol R Measure the absorbance (2.2.25) at the maximum at 287 nm Calculate the content of C23H30O4 taking the specific absorbance to be 685 STORAGE Store protected from light IMPURITIES CHARACTERS Appearance : clear, colourless or light yellow, viscous liquid Solubility : miscible with water, with alcohol and with vegetable oils IDENTIFICATION A Infrared absorption spectrophotometry (2.2.24) Comparison : Ph Eur reference spectrum of nonoxinol Preparation : film between sodium chloride R plates B It complies with the test for cloud point (see Tests) TESTS Acidity or alkalinity Boil 1.0 g with 20 ml of carbon dioxide-free water R for min, with constant stirring Cool and filter To 10 ml of the filtrate, add 0.05 ml of bromothymol blue solution R1 Not more than 0.5 ml of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator Hydroxyl value (2.5.3, Method A) : 84 to 94 Cloud point : 52 °C to 58 °C Dissolve 1.0 g in 99 g of water R Transfer about 30 ml of this solution into a test-tube, heat on a water-bath and stir continuously until the solution becomes cloudy Remove the test-tube from the water-bath (ensuring that the temperature does not increase more than °C) and continue to stir The cloud point is the temperature at which the solution becomes sufficiently clear that the entire thermometer bulb is plainly seen Ethylene oxide and dioxan (2.4.25) : maximum ppm of ethylene oxide and maximum 10 ppm of dioxan Heavy metals (2.4.8) : maximum 10 ppm Dissolve 2.0 g in distilled water R and dilute to 20.0 ml with the same solvent 12 ml of this solution complies with limit test A Prepare the standard using lead standard solution (1 ppm Pb) R Water (2.5.12) : maximum 0.5 per cent, determined on 2.00 g Total ash (2.4.16) : maximum 0.4 per cent, determined on 1.0 g STORAGE In an airtight container 01/2005:0732 NORADRENALINE HYDROCHLORIDE Noradrenalini hydrochloridum A 6α-methyl-3,20-dioxo-19-norpregn-4-en-17-yl acetate 01/2005:1454 C8H12ClNO3 NONOXINOL Nonoxinolum DEFINITION α-(4-Nonylphenyl)-ω-hydroxynona(oxyethylene) Mixture consisting mainly of monononylphenyl ethers of macrogols corresponding to the formula : C9H19C6H4-[OCH2-CH2]n-OH where the average value of n is It may contain free macrogols 2114 Mr 205.6 DEFINITION (R)-2-Amino-1-(3,4-dihydroxyphenyl)ethanol hydrochloride Content : 98.5 per cent to 101.0 per cent (anhydrous substance) CHARACTERS Appearance : white or brownish-white, crystalline powder Solubility : very soluble in water, slightly soluble in alcohol It becomes coloured on exposure to air and light See the information section on general monographs (cover pages) Noradrenaline tartrate EUROPEAN PHARMACOPOEIA 5.0 IDENTIFICATION A Specific optical rotation (see Tests) B Infrared absorption spectrophotometry (2.2.24) Dissolve g in 20 ml of a g/l solution of sodium metabisulphite R and make alkaline by addition of ammonia R Keep in iced water for h and filter Wash the precipitate with quantities, each of ml, of water R, with ml of alcohol R and finally with ml of ether R and dry in vacuo for h Examine the noradrenaline base thus prepared, comparing with the spectrum obtained with noradrenaline base prepared by the same method from a suitable amount of noradrenaline tartrate CRS Examine the substances prepared as discs C 0.2 ml of solution S (see Tests) gives reaction (a) of chlorides (2.3.1) TESTS Solution S Dissolve 0.500 g in carbon dioxide-free water R and dilute to 25.0 ml with the same solvent Appearance of solution The solution is clear (2.2.1) and not more intensely coloured than a mixture of 0.2 ml of blue primary solution, 0.4 ml of yellow primary solution, 0.4 ml of red primary solution and ml of a 13.7 per cent V/V solution of dilute hydrochloric acid R (2.2.2, Method II) Dissolve 0.2 g in carbon dioxide-free water R and dilute to 10 ml with the same solvent Examine the solution immediately pH (2.2.3) : 3.5 to 4.5 for solution S Specific optical rotation (2.2.7) : − 37 to − 41, determined on solution S (anhydrous substance) Noradrenalone : maximum 0.12 per cent Dissolve 30.0 mg in 0.01 M hydrochloric acid and dilute to 25.0 ml with the same acid The absorbance (2.2.25) of the solution measured at 310 nm is not greater than 0.20 Adrenaline Thin-layer chromatography (2.2.27) Test solution Dissolve 0.15 g of the substance to be examined in water R and dilute to 10 ml with the same solvent Prepare immediately before use Reference solution (a) Dissolve 12.5 mg of adrenaline tartrate CRS in water R and dilute to 10 ml with the same solvent Prepare immediately before use Reference solution (b) Dilute ml of reference solution (a) to 10 ml with water R Reference solution (c) Mix ml of the test solution and ml of reference solution (b) Plate : TLC silica gel G plate R Mobile phase : anhydrous formic acid R, acetone R, methylene chloride R (0.5:50:50 V/V/V) Application : apply as bands 20 mm by mm, µl of the test solution, µl of reference solution (a), µl of reference solution (b) and 12 µl of reference solution (c) Allow to dry in air and spray the bands with a saturated solution of sodium hydrogen carbonate R Allow the plate to dry in air and spray the bands twice with acetic anhydride R, drying between the sprayings Heat the plate at 50 °C for 90 Development : over a path of 15 cm Drying : in air Detection : spray with a solution freshly prepared by mixing volumes of ethylenediamine R and volumes of methanol R and adding volumes of a g/l solution of potassium ferricyanide R Dry the plate at 60 °C for 10 and examine in ultraviolet light at 254 nm and 365 nm General Notices (1) apply to all monographs and other texts System suitability : the chromatogram obtained with reference solution (c) shows above the most intense zone a clearly separated zone corresponding to the most intense zone in the chromatogram obtained with reference solution (a) Limits : any zone situated immediately above the most intense zone is not more intense than the corresponding zone in the chromatogram obtained with reference solution (b) (1.0 per cent) Water (2.5.12) : maximum 0.5 per cent, determined on 1.000 g Sulphated ash (2.4.14) : maximum 0.1 per cent, determined on 0.50 g ASSAY Dissolve 0.180 g in 50 ml of acetic anhydride R and add 10 ml of anhydrous formic acid R Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20) ml of 0.1 M perchloric acid is equivalent to 20.56 mg of C8H12ClNO3 STORAGE Store in an airtight container, or preferably in a sealed tube under vacuum or under an inert gas, protected from light 01/2005:0285 NORADRENALINE TARTRATE Noradrenalini tartras C12H17NO9,H2O Mr 337.3 DEFINITION (1R)-2-Amino-1-(3,4-dihydroxyphenyl)ethanol hydrogen (2R,3R)-2,3-dihydroxybutanedioate monohydrate Content : 98.5 per cent to 101.0 per cent (anhydrous substance) CHARACTERS Appearance : white or almost white, crystalline powder Solubility : freely soluble in water, slightly soluble in alcohol IDENTIFICATION A Dissolve g in 20 ml of a g/l solution of sodium metabisulphite R and make alkaline by addition of ammonia R Keep in iced water for h and filter Reserve the filtrate for identification test C Wash the precipitate with quantities, each of ml, of water R, with ml of alcohol R and finally with ml of ether R and dry in vacuo for h The specific optical rotation (2.2.7) of the precipitate (noradrenaline base) is − 44 to − 48, determined using a 20.0 g/l solution in 0.5 M hydrochloric acid B Infrared absorption spectrophotometry (2.2.24) Use noradrenaline base prepared as described under identification test A and compare with the spectrum obtained with noradrenaline base prepared by the same method from a suitable amount of noradrenaline tartrate CRS Examine the substances prepared as discs C 0.2 ml of the filtrate obtained in identification test A gives reaction (b) of tartrates (2.3.1) 2115 Norethisterone EUROPEAN PHARMACOPOEIA 5.0 TESTS Appearance of solution The solution is clear (2.2.1) and not more intensely coloured than reference solution BY5 (2.2.2, Method II) Dissolve 0.2 g in water R and dilute to 10 ml with the same solvent Examine the solution immediately Noradrenalone : the absorbance (2.2.25) of the solution measured at 310 nm is not greater than 0.20 Dissolve 50.0 mg in 0.01 M hydrochloric acid and dilute to 25.0 ml with the same acid Adrenaline Thin-layer chromatography (2.2.27) Test solution Dissolve 0.25 g of the substance to be examined in water R and dilute to 10 ml with the same solvent Prepare immediately before use Reference solution (a) Dissolve 12.5 mg of adrenaline tartrate CRS in water R and dilute to 10 ml with the same solvent Prepare immediately before use Reference solution (b) Dilute ml of reference solution (a) to 10 ml with water R Reference solution (c) Mix ml of the test solution with ml of reference solution (b) Plate : TLC silica gel G plate R Mobile phase : anhydrous formic acid R, acetone R, methylene chloride R (0.5:50:50 V/V/V) Application : apply as bands 20 mm by mm, µl of the test solution, µl of reference solution (a), µl of reference solution (b) and 12 µl of reference solution (c) Allow to dry in air and spray the bands with a saturated solution of sodium hydrogen carbonate R Allow the plate to dry in air and spray the bands twice with acetic anhydride R, drying between the sprayings Heat the plate at 50 °C for 90 Development : over a path of 15 cm Drying : in air Detection : spray with a solution freshly prepared by mixing volumes of ethylenediamine R and volumes of methanol R and adding volumes of a g/l solution of potassium ferricyanide R Dry the plate at 60 °C for 10 and examine in ultraviolet light at 254 nm and 365 nm System suitability : the chromatogram obtained with reference solution (c) shows above the most intense zone a clearly separated zone corresponding to the most intense zone in the chromatogram obtained with reference solution (a) Limit : — adrenaline : any zone situated immediately above the most intense zone is not more intense than the corresponding zone in the chromatogram obtained with reference solution (b) (1.0 per cent) Water (2.5.12) : 4.5 per cent to 5.8 per cent, determined on 0.500 g Sulphated ash (2.4.14) : maximum 0.1 per cent, determined on 0.5 g 01/2005:0234 NORETHISTERONE Norethisteronum C20H26O2 Mr 298.4 DEFINITION Norethisterone contains not less than 98.0 per cent and not more than the equivalent of 102.0 per cent of 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, calculated with reference to the dried substance CHARACTERS A white or yellowish-white, crystalline powder, practically insoluble in water, slightly soluble in alcohol It melts at about 206 °C, with decomposition IDENTIFICATION First identification : A, B, E Second identification : B, C, D, E A Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with norethisterone CRS Examine the substances prepared in the form of discs If the spectra obtained with the substance to be examined and the reference substance show differences, dissolve the substances in chloroform R, evaporate to dryness on a water-bath and then record the spectra B Examine by thin-layer chromatography (2.2.27), using kieselguhr G R as the coating substance Impregnate the plate by placing it in a tank containing the necessary quantity of a mixture of 10 volumes of formamide R and 90 volumes of acetone R so that the plate dips about mm into the liquid When the front of the impregnation mixture has risen at least cm above the level prescribed for the mobile phase, remove the plate and allow it to stand at room temperature until the solvent has completely evaporated (about to min) Use the impregnated plate within h and carry out the chromatography in the same direction as the impregnation Test solution Dissolve 10 mg of the substance to be examined in chloroform R and dilute to 10 ml with the same solvent Reference solution Dissolve 10 mg of norethisterone CRS in chloroform R and dilute to 10 ml with the same solvent ASSAY Apply separately to the plate µl of each solution Dissolve 0.300 g in 50 ml of anhydrous acetic acid R, Develop over a path of 15 cm using a mixture of heating gently if necessary Titrate with 0.1 M perchloric 20 volumes of dioxan R and 80 volumes of hexane R acid using 0.1 ml of crystal violet solution R as indicator, Heat the plate at 120 °C for 15 and spray with until a bluish-green colour is obtained alcoholic solution of sulphuric acid R Heat at 120 °C for 10 to 15 or until the spots appear Allow ml of 0.1 M perchloric acid is equivalent to 31.93 mg of to cool and examine in daylight and in ultraviolet light C12H17NO9 at 365 nm The principal spot in the chromatogram STORAGE obtained with the test solution is similar in position, colour, fluorescence and size to the principal spot in the In an airtight container, or preferably in a sealed tube under chromatogram obtained with the reference solution vacuum or under an inert gas, protected from light 2116 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.0 Norethisterone acetate ASSAY C Dissolve about mg in ml of alcohol R, add ml of ammoniacal silver nitrate solution R and heat on a Dissolve 0.200 g in 40 ml of tetrahydrofuran R Add 10 ml water-bath The solution becomes turbid and a white of a 100 g/l solution of silver nitrate R Using ml of precipitate is formed which becomes grey when heated A bromocresol green solution R as indicator, titrate with 0.1 M silver mirror is deposited on the walls of the tube sodium hydroxide until a violet colour is obtained Carry out a blank titration D Dissolve about mg in a cooled mixture of ml of ethanol R and ml of sulphuric acid R and heat to 70 °C ml of 0.1 M sodium hydroxide is equivalent to 29.84 mg of The resulting solution is dichroic, appearing blue-violet in C20H26O2 transmitted light and red in reflected light The solution STORAGE shows a bright-red fluorescence in ultraviolet light at Store protected from light 365 nm E Dissolve about mg in ml of alcohol R, add ml of a 10 g/l solution of butylhydroxytoluene R in alcohol R and ml of M sodium hydroxide Heat in a water-bath at 80 °C for 30 and cool to room temperature A yellowish-pink colour is produced 01/2005:0850 NORETHISTERONE ACETATE Norethisteroni acetas TESTS Solution S Dissolve 0.200 g in dioxan R and dilute to 10.0 ml with the same solvent Appearance of solution Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method I) Specific optical rotation (2.2.7) Dilute 5.0 ml of solution S C H O Mr 340.5 to 10.0 ml with dioxan R The specific optical rotation is − 33 22 28 to − 37, calculated with reference to the dried substance DEFINITION 3-Oxo-19-nor-17α-pregn-4-en-20-yn-17-yl acetate Absorbance (2.2.25) Dissolve 10.0 mg in alcohol R and dilute to 100.0 ml with the same solvent Dilute 10.0 ml of Content : 98.0 per cent to 101.0 per cent (dried substance) this solution to 100.0 ml with alcohol R The solution shows an absorption maximum at 240 nm The specific absorbance CHARACTERS at the maximum is 550 to 590, calculated with reference to Appearance : white or yellowish-white, crystalline powder the dried substance Solubility : practically insoluble in water, freely soluble in Related substances Examine by thin-layer chromatography methylene chloride, soluble in alcohol (2.2.27), using a suitable silica gel as the coating substance It shows polymorphism IDENTIFICATION Test solution Dissolve 50 mg of the substance to be examined in a mixture of volume of methanol R and Infrared absorption spectrophotometry (2.2.24) volumes of chloroform R and dilute to 10 ml with the same Preparation : discs mixture of solvents Comparison : norethisterone acetate CRS Reference solution (a) Dilute 1.0 ml of the test solution If the spectra show differences, dissolve the substance to to 200 ml with a mixture of volume of methanol R and be examined and the reference substance separately in volumes of chloroform R methylene chloride R, evaporate to dryness on a water-bath and record new spectra using the residues Reference solution (b) Dissolve 25 mg of ethisterone CRS TESTS in a mixture of volume of methanol R and volumes of chloroform R, add ml of the test solution and dilute to Specific optical rotation (2.2.7) − 30 to − 35 (dried 100 ml with the same mixture of solvents substance) Dissolve 0.500 g in ethanol R and dilute to 25.0 ml with the Apply separately to the plate, as two applications of µl, same solvent 10 µl of each solution Develop over a path of 15 cm using a mixture of 10 volumes of acetone R and 90 volumes Related substances Liquid chromatography (2.2.29) of chloroform R Allow the plate to dry in air, spray with Test solution Dissolve 25.0 mg of the substance to be alcoholic solution of sulphuric acid R and heat at 100 °C to examined in the mobile phase and dilute to 10.0 ml with the 105 °C for Examine in ultraviolet light at 365 nm mobile phase Reference solution (a) Dissolve mg of desoxycortone Any spot in the chromatogram obtained with the test acetate CRS and mg of norethisterone acetate CRS in the solution, apart from the principal spot, is not more intense than the spot in the chromatogram obtained with reference mobile phase and dilute to 50.0 ml with the mobile phase Reference solution (b) Dilute 1.0 ml of the test solution to solution (a) (0.5 per cent) The test is not valid unless the 100.0 ml with the mobile phase chromatogram obtained with reference solution (b) shows two clearly separated spots of approximately equal intensity Column : — size : l = 0.25 m, Ø = 4.6 mm, Loss on drying (2.2.32) Not more than 0.5 per cent, determined on 1.00 g by drying in an oven at 100 °C to — stationary phase : octadecylsilyl silica gel for 105 °C for h chromatography R (5 µm) General Notices (1) apply to all monographs and other texts 2117 Norfloxacin EUROPEAN PHARMACOPOEIA 5.0 Mobile phase : acetonitrile R, water R (60:40 V/V) Flow rate : 1.0 ml/min Detection : variable wavelength spectrophotometer capable of operating at 254 nm and at 210 nm Injection : 20 µl Run time : times the retention time of norethisterone acetate Relative retention with reference to norethisterone acetate (retention time = about 10 min) : impurity A = about 0.48 ; impurity D = about 0.65 ; impurity E = about 0.83 ; impurity C = about 1.35 ; impurity B = about 1.40 System suitability : reference solution (a) at 254 nm : — resolution : minimum of 3.5 between the peaks due to norethisterone acetate and to desoxycortone acetate Limits : spectrophotometer at 254 nm : — any impurity : not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent), — total: not more than 0.75 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.75 per cent), — disregard limit : 0.05 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent) Limits : spectrophotometer at 210 nm : — any impurity with a relative retention between 1.0 and 1.6, with reference to norethisterone acetate (retention time = about 10 min) : not more than 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent), — total of these impurities: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent), — disregard limit : 0.05 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent) Loss on drying (2.2.32) : maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 100-105 °C ASSAY Dissolve 0.200 g in 40 ml of tetrahydrofuran R Add 10 ml of a 100 g/l solution of silver nitrate R and titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20) Carry out a blank titration ml of 0.1 M sodium hydroxide is equivalent to 34.05 mg of C22H28O3 IMPURITIES Specified impurities : A, B, C, D, E Other detectable impurities : F, G A norethisterone, B 3-oxo-19-nor-17α-pregn-5(10)-en-20-yn-17-yl acetate, 2118 C 3-oxo-19-nor-17α-pregn-5-en-20-yn-17-yl acetate, D R1 = H, R2 = CO-CH3, R3 = C≡CH : 6β-acetyl-3-oxo-19-nor17α-pregn-4-en-20-yn-17-yl acetate, E R1 = R2 = H, R3 = CO-CH3 : 3,20-dioxo-19-nor-17α-pregn4-en-17-yl acetate, F R1 = H, R2 = OH, R3 = C≡CH : 6β-hydroxy-3-oxo-19-nor17α-pregn-4-en-20-yn-17-yl acetate, G R1 + R2 = O, R3 = C≡CH : 3,6-dioxo-19-nor-17α-pregn-4en-20-yn-17-yl acetate 01/2005:1248 NORFLOXACIN Norfloxacinum C16H18FN3O3 Mr 319.3 DEFINITION Norfloxacin contains not less than 99.0 per cent and not more than the equivalent of 101.0 per cent of 1-ethyl-6-fluoro4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid, calculated with reference to the dried substance CHARACTERS A white or pale-yellow, hygroscopic, photosensitive, crystalline powder, very slightly soluble in water, slightly soluble in acetone and in alcohol IDENTIFICATION Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with norfloxacin CRS Examine the substances prepared as discs TESTS Appearance of solution Dissolve 0.5 g in a previously filtered g/l solution of sodium hydroxide R in methanol R and dilute to 50 ml with the same solution The solution is not more opalescent than reference suspension II (2.2.1) and not more intensely coloured than reference solution B7 (2.2.2, Method II) See the information section on general monographs (cover pages) Norgestrel EUROPEAN PHARMACOPOEIA 5.0 Related substances Examine by thin-layer chromatography (2.2.27), using a TLC silica gel GF254 plate R, previously washed with methanol R and dried in air Test solution (a) Dissolve 40 mg of the substance to be examined in a mixture of equal volumes of methanol R and methylene chloride R and dilute to ml with the same mixture of solvents Test solution (b) Dilute ml of test solution (a) to 10 ml with a mixture of equal volumes of methanol R and methylene chloride R Reference solution (a) Dilute ml of test solution (b) to 50 ml with a mixture of equal volumes of methanol R and methylene chloride R Reference solution (b) Dissolve 4.0 mg of norfloxacin impurity A CRS in a mixture of equal volumes of methanol R and methylene chloride R and dilute to ml with the same mixture of solvents Dilute ml of this solution to ml with test solution (b) Apply to the plate µl of test solution (a) and µl of each reference solution Develop over a path of 18 cm using a mixture of volumes of water R, 14 volumes of diethylamine R, 20 volumes of toluene R, 40 volumes of chloroform R and 40 volumes of methanol R Dry the plate in a current of air and examine in ultraviolet light at 254 nm and then 365 nm Any spot in the chromatogram obtained with test solution (a), apart from the principal spot, is not more intense than the principal spot in the chromatogram obtained with reference solution (a) (0.2 per cent) and there are no more than three such spots The test is not valid unless, in the chromatogram obtained with reference solution (b), the ratio of the Rf value of impurity A to the Rf value of norfloxacin is at least 1.2 Heavy metals (2.4.8) 2.0 g complies with limit test D for heavy metals (15 ppm) Prepare the standard using ml of lead standard solution (10 ppm Pb) R Loss on drying (2.2.32) Not more than 1.0 per cent, determined on 1.000 g by drying in an oven at 100-105 °C under high vacuum for h Sulphated ash (2.4.14) Not more than 0.1 per cent, determined on 1.0 g in a platinum crucible 01/2005:0940 NORGESTREL Norgestrelum C21H28O2 Mr 312.5 DEFINITION Norgestrel contains not less than 98.0 per cent and not more than the equivalent of 102.0 per cent of rac-13-ethyl-17hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, calculated with reference to the dried substance CHARACTERS A white or almost white, crystalline powder, practically insoluble in water, sparingly soluble in methylene chloride, slightly soluble in alcohol IDENTIFICATION A Dissolve 0.5 g in methylene chloride R and dilute to 10.0 ml with the same solvent The angle of optical rotation (2.2.7) is + 0.05° to − 0.05° B Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with norgestrel CRS TESTS Related substances Examine by thin-layer chromatography (2.2.27), using silica gel G R as the coating substance Test solution Dissolve 0.2 g of the substance to be examined in methylene chloride R and dilute to 10 ml with the same solvent Reference solution (a) Dilute ml of the test solution to 10 ml with methylene chloride R Dilute ml of this solution ASSAY to 20 ml with methylene chloride R Dissolve 0.240 g in 80 ml of anhydrous acetic acid R Titrate Reference solution (b) Dilute ml of reference solution (a) with 0.1 M perchloric acid, determining the end-point to 10 ml with methylene chloride R potentiometrically (2.2.20) Reference solution (c) Dissolve mg of norgestrel CRS and ml of 0.1 M perchloric acid is equivalent to 31.93 mg of mg of ethinylestradiol CRS in methylene chloride R and C16H18FN3O3 dilute to 50 ml with the same solvent Apply to the plate 10 µl of each solution Develop over STORAGE a path of 15 cm using a mixture of 20 volumes of ethyl Store in an airtight container, protected from light acetate R and 80 volumes of methylene chloride R Allow the plate to dry in air, spray with a 100 g/l solution of IMPURITIES phosphomolybdic acid R in alcohol R, heat at 100-105 °C for 15 and examine immediately Any spot in the chromatogram obtained with the test solution, apart from the principal spot, is not more intense than the principal spot in the chromatogram obtained with reference solution (a) (0.5 per cent) and at most two such spots are more intense than the spot in the chromatogram obtained with reference solution (b) (0.2 per cent) The test is not valid unless the chromatogram obtained with reference solution (c) shows two clearly separated spots A R = Cl : 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4Loss on drying (2.2.32) Not more than 0.5 per cent, dihydroquinoline-3-carboxylic acid, determined on 1.000 g by drying in an oven at 100-105 °C Sulphated ash (2.4.14) Not more than 0.1 per cent, B R = NH-CH2-CH2-NH2 : 7-[(2-aminoethyl)amino]-1-ethyl-6determined on 1.0 g fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid General Notices (1) apply to all monographs and other texts 2119 Index EUROPEAN PHARMACOPOEIA 5.1 Fatty acids, composition by gas chromatography (2.4.22.) .110 Fatty oils, alkaline impurities in (2.4.19.) 109 Fatty oils and herbal drugs, heavy metals in (2.4.27.) 119 Fatty oils and resinified essential oils in essential oils (2.8.7.) 216 Fatty oils, foreign oils in, by thin-layer chromatography (2.4.21.) 109 Fatty oils, identification by thin-layer chromatography (2.3.2.) 98 Fatty oils, sterols in (2.4.23.) 5.1-2787 Fc function of immunoglobulin, test for (2.7.9.) 202 Feline calicivirosis vaccine (inactivated) 757 Feline calicivirosis vaccine (live), freeze-dried 758 Feline infectious enteritis (feline panleucopenia) vaccine (inactivated) 759 Feline infectious enteritis (feline panleucopenia) vaccine (live) 760 Feline leukaemia vaccine (inactivated) 761 Feline panleucopenia vaccine (inactivated) 759 Feline panleucopenia vaccine (live) 760 Feline viral rhinotracheitis vaccine (inactivated) 762 Feline viral rhinotracheitis vaccine (live), freeze-dried 763 Felodipine 1576 Felodipinum 1576 Fenbendazole for veterinary use 1577 Fenbendazolum ad usum veterinarium 1577 Fenbufen 1578 Fenbufenum 1578 Fennel, bitter 1580 Fennel, sweet 1580 Fenofibrate 1581 Fenofibratum 1581 Fenoterol hydrobromide .1583 Fenoteroli hydrobromidum 1583 Fentanyl .1584 Fentanyl citrate .1585 Fentanyli citras 1585 Fentanylum .1584 Fenticonazole nitrate 1586 Fenticonazoli nitras .1586 Fenugreek 1588 Fermentation, products of 576 Ferric chloride hexahydrate 1588 Ferri chloridum hexahydricum 1588 Ferrosi fumaras .1589 Ferrosi gluconas 1590 Ferrosi sulfas heptahydricus 1591 Ferrous fumarate .1589 Ferrous gluconate 1590 Ferrous sulphate heptahydrate 1591 Ferrum ad praeparationes homoeopathicas 899 Feverfew .1592 Fibrini glutinum 1593 Fibrinogen, human 1740 Fibrinogenum humanum 1740 Fibrin sealant kit 1593 Fila non resorbilia sterilia 874 Fila non resorbilia sterilia in fuso ad usum veterinarium 888 Fila resorbilia synthetica monofilamenta sterilia 880 Fila resorbilia synthetica torta sterilia 878 Filipendulae ulmariae herba 1980 Filum bombycis tortum sterile in fuso ad usum veterinarium 887 Filum ethyleni polyterephthalici sterile in fuso ad usum veterinarium 887 Filum lini sterile in fuso ad usum veterinarium 886 3062 Filum polyamidicum-6/6 sterile in fuso ad usum veterinarium 887 Filum polyamidicum-6 sterile in fuso ad usum veterinarium 886 Finasteride .1594 Finasteridum 1594 Fish oil, rich in omega-3-acids .1595 Flecainide acetate 1598 Flecainidi acetas .1598 Flowability (2.9.16.) 242 Flubendazole 1599 Flubendazolum 1599 Flucloxacillin sodium .5.1-2925 Flucloxacillinum natricum 5.1-2925 Flucytosine 1602 Flucytosinum 1602 Fludarabine phosphate 5.1-2926 Fludarabini phosphas .5.1-2926 Fludeoxyglucose (18F) injection 822 Fludeoxyglucosi (18F) solutio iniectabilis 822 Fludrocortisone acetate 1603 Fludrocortisoni acetas 1603 Flumazenil 1604 Flumazenil (N-[11C]methyl) injection 825 Flumazenil (N-[11C]methyl) solutio iniectabilis 825 Flumazenilum 1604 Flumequine 1605 Flumequinum 1605 Flumetasone pivalate 1607 Flumetasoni pivalas 1607 Flunarizine dihydrochloride 1608 Flunarizini dihydrochloridum 1608 Flunitrazepam 1609 Flunitrazepamum 1609 Flunixini megluminum ad usum veterinarium .5.1-2929 Flunixin meglumine for veterinary use 5.1-2929 Fluocinolone acetonide 1610 Fluocinoloni acetonidum 1610 Fluocortolone pivalate 1611 Fluocortoloni pivalas 1611 Fluorescein sodium 1613 Fluoresceinum natricum 1613 Fluorides (2.4.5.) 104 Fluorimetry (2.2.21.) 35 Fluorouracil 1614 Fluorouracilum 1614 Fluoxetine hydrochloride 1615 Fluoxetini hydrochloridum 1615 Flupentixol dihydrochloride 1617 Flupentixoli dihydrochloridum 1617 Fluphenazine decanoate 1619 Fluphenazine enantate 1620 Fluphenazine hydrochloride 1621 Fluphenazini decanoas 1619 Fluphenazini enantas 1620 Fluphenazini hydrochloridum 1621 Flurazepami monohydrochloridum 1622 Flurazepam monohydrochloride 1622 Flurbiprofen 1623 Flurbiprofenum 1623 Fluspirilene 1625 Fluspirilenum 1625 Flutamide 1626 Flutamidum 1626 Fluticasone propionate 1627 Fluticasoni propionas 1627 Flutrimazole 1629 Flutrimazolum 1629 Foams, cutaneous 608 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.1 Index G Galactose 1649 Galactosum 1649 Gallamine triethiodide 1649 Gallamini triethiodidum 1649 Gallii (67Ga) citratis solutio iniectabilis 826 Gallium (67Ga) citrate injection 826 Gargles 612 Garlic for homoeopathic preparations 897 Garlic powder 1651 Gas chromatography (2.2.28.) 42 Gas detector tubes (2.1.6.) 19 Gases, carbon dioxide in (2.5.24.) 134 Gases, carbon monoxide in (2.5.25.) 134 Gases, nitrogen monoxide and nitrogen dioxide in (2.5.26.) 135 Gases, nitrous oxide in (2.5.35.) .141 Gases, oxygen in (2.5.27.) 136 Gases, water in (2.5.28.) 136 Gas-gangrene antitoxin, mixed 802 Gas-gangrene antitoxin (novyi) 802 Gas-gangrene antitoxin (perfringens) 803 Gas-gangrene antitoxin (septicum) 804 Gastro-resistant capsules 600 Gastro-resistant granules 606 Gastro-resistant tablets 628 Gelatin 1651 Gelatina 1651 Gels 625 Gels for injections .5.1-2843 General chapters (1.3.) General notices (1.) .5 General statements (1.1.) .5 General texts on sterility (5.1.) 445 General texts on vaccines (5.2.) 453 Gentamicini sulfas 1653 Gentamicin sulphate 1653 Gentianae radix 1654 Gentianae tinctura 1655 Gentian root 1654 Gentian tincture 1655 Ginger 1656 Gingival solutions 612 Ginkgo folium 1657 Ginkgo leaf 1657 Ginseng 5.1-2935 Ginseng radix 5.1-2935 Glass containers for pharmaceutical use (3.2.1.) 303 Glibenclamide 1659 Glibenclamidum 1659 Gliclazide 1660 Gliclazidum 1660 Glipizide 1662 Glipizidum 1662 Glossary (dosage forms) 599 Glucagon 1663 Glucagon, human 1665 Glucagonum 1663 Glucagonum humanum 1665 Glucose, anhydrous 1666 Glucose, liquid 1667 Glucose, liquid, spray-dried 1668 Glucose monohydrate 1669 Glucosum anhydricum 1666 Glucosum liquidum 1667 Glucosum liquidum dispersione desiccatum 1668 Glucosum monohydricum 1669 Glutamic acid 1670 Glutathione .5.1-2936 Glutathionum 5.1-2936 Glycerol 1671 Glycerol (85 per cent) 1672 Glycerol dibehenate 5.1-2938 Glycerol distearate 1674 Glyceroli dibehenas 5.1-2938 Glyceroli distearas 1674 Glyceroli monolinoleas 1675 Glyceroli mono-oleates 1676 Glyceroli monostearas 40-55 1677 Glyceroli trinitratis solutio 1678 Glycerol monolinoleate 1675 Glycerol mono-oleates 1676 Glycerol monostearate 40-55 1677 Glycerol triacetate 2612 Glycerolum 1671 Glycerolum (85 per centum) 1672 Glyceryl trinitrate solution 1678 Glycine 1680 General Notices (1) apply to all monographs and other texts 3063 Foams, medicated 604 Foams, rectal 624 Foams, vaginal 630 Foeniculi amari fructus .1580 Foeniculi amari fructus aetheroleum 1108 Foeniculi dulcis fructus .1580 Folic acid 1630 Foot-and-mouth disease (ruminants) vaccine (inactivated) .5.1-2860 Foreign esters in essential oils (2.8.6.) 216 Foreign matter (2.8.2.) 215 Foreign oils in fatty oils by thin-layer chromatography (2.4.21.) 109 Formaldehyde, free (2.4.18.) 109 Formaldehyde solution (35 per cent) 1632 Formaldehydi solutio (35 per centum) 1632 Formoterol fumarate dihydrate 1632 Formoteroli fumaras dihydricus 1632 Foscarnet sodium hexahydrate 1634 Foscarnetum natricum hexahydricum 1634 Fosfomycin calcium 1636 Fosfomycin sodium 1637 Fosfomycin trometamol 1638 Fosfomycinum calcicum 1636 Fosfomycinum natricum 1637 Fosfomycinum trometamolum 1638 Fowl cholera vaccine (inactivated) 5.1-2861 Fowl-pox vaccine (live) 766 Framycetini sulfas 1639 Framycetin sulphate 1639 Frangula bark 1641 Frangula bark dry extract, standardised 1642 Frangulae cortex 1641 Frangulae corticis extractum siccum normatum 1642 Fraxini folium 1026 Free formaldehyde (2.4.18.) 109 Freezing point (2.2.18.) 34 Friability of uncoated tablets (2.9.7.) 234 Fructose 1643 Fructosum 1643 Fucus 1869 Fucus vel Ascophyllum 1869 Functional groups and ions, identification reactions (2.3.1.) 95 Furosemide .5.1-2930 Furosemidum 5.1-2930 Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) for salmonids 767 Fusidic acid 1645 Index EUROPEAN PHARMACOPOEIA 5.1 Glycinum 1680 Glycyrrhizate ammonium 5.1-2876 Goldenrod 1680 Goldenrod, European 1682 Goldenseal rhizome 1683 Gonadorelin acetate 1684 Gonadorelini acetas 1684 Gonadotrophin, chorionic 1686 Gonadotrophin, equine serum, for veterinary use 1686 Gonadotropinum chorionicum 1686 Gonadotropinum sericum equinum ad usum veterinarium 1686 Goserelin 1687 Goserelinum 1687 Gossypii oleum hydrogenatum 1370 Gramicidin 1689 Gramicidinum 1689 Graminis rhizoma 1371 Granisetron hydrochloride 5.1-2939 Granisetroni hydrochloridum .5.1-2939 Granulata 605 Granules 605 Granules, coated 606 Granules, effervescent 606 Granules, gastro-resistant 606 Granules, modified-release 606 Greater celandine 1690 Griseofulvin 1691 Griseofulvinum 1691 Guaifenesin 1692 Guaifenesinum 1692 Guanethidine monosulphate 1694 Guanethidini monosulfas 1694 Guar 1694 Guar galactomannan 1695 Guar galactomannanum 1695 H Haemodiafiltration and for haemofiltration, solutions for 1703 Haemodialysis, concentrated solutions for 1700 Haemodialysis solutions, concentrated, water for diluting 1699 Haemodialysis, solutions for 1700 Haemofiltration and for haemodiafiltration, solutions for 1703 Haemophilus type b (conjugate), diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) 653 Haemophilus type b (conjugate), diphtheria, tetanus, pertussis and poliomyelitis (inactivated) vaccine (adsorbed) 657 Haemophilus type b conjugate vaccine 662 Halofantrine hydrochloride 1705 Halofantrini hydrochloridum 1705 Haloperidol 1706 Haloperidol decanoate 1708 Haloperidoli decanoas 1708 Haloperidolum 1706 Halothane 1709 Halothanum 1709 Hamamelidis folium 1711 Hamamelis leaf 1711 Hard capsules 600 Hard fat 1711 Hard paraffin 2186 Harpagophyti radix 1401 Hawthorn berries 1712 Hawthorn leaf and flower 1713 3064 Hawthorn leaf and flower dry extract 1714 Heavy bismuth subnitrate 1107 Heavy kaolin 1869 Heavy magnesium carbonate 1954 Heavy magnesium oxide 1958 Heavy metals (2.4.8.) 104 Heavy metals in herbal drugs and fatty oils (2.4.27.) 119 Hederae folium 5.1-2954 Helianthi annui oleum raffinatum 2524 Heparina massae molecularis minoris 1717 Heparin, assay of (2.7.5.) 195 Heparin calcium 1715 Heparin in coagulation factors, assay of (2.7.12.) 204 Heparins, low-molecular-mass 1717 Heparin sodium 1716 Heparinum calcicum 1715 Heparinum natricum 1716 Hepatitis A immunoglobulin, human 1741 Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (adsorbed) 664 Hepatitis A vaccine, assay of (2.7.14.) 5.1-2795 Hepatitis A vaccine (inactivated, adsorbed) 665 Hepatitis A vaccine (inactivated, virosome) 667 Hepatitis B immunoglobulin for intravenous administration, human .1741 Hepatitis B immunoglobulin, human 1741 Hepatitis B (rDNA), diphtheria and tetanus vaccine (adsorbed) 641 Hepatitis B (rDNA), diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed) 647 Hepatitis B vaccine (rDNA) 670 Hepatitis B vaccine (rDNA), assay of (2.7.15.) 207 Hepatitis C virus (HCV), validation of nucleic acid amplification techniques for the detection of HCV RNA in plasma pools : Guidelines 176 Heptaminol hydrochloride 1719 Heptaminoli hydrochloridum 1719 Herbal drug preparations 572 Herbal drugs 572 Herbal drugs and fatty oils, heavy metals in (2.4.27.) .119 Herbal drugs, determination of tannins (2.8.14.) 221 Herbal drugs for homoeopathic preparations 893 Herbal teas 573 Hexamidine diisetionate 1720 Hexamidini diisetionas 1720 Hexetidine 1721 Hexetidinum 1721 Hexobarbital 1722 Hexobarbitalum 1722 Hexosamines in polysaccharide vaccines (2.5.20.) 132 Hexylresorcinol 1723 Hexylresorcinolum 1723 Hibisci sabdariffae flos 2376 Highly purified water 2695 Histamine (2.6.10.) 153 Histamine dihydrochloride 1724 Histamine phosphate 1725 Histamini dihydrochloridum 1724 Histamini phosphas 1725 Histidine 5.1-2945 Histidine hydrochloride monohydrate 1727 Histidini hydrochloridum monohydricum 1727 Histidinum 5.1-2945 Homatropine hydrobromide 1728 Homatropine methylbromide 1729 Homatropini hydrobromidum 1728 Homatropini methylbromidum 1729 Homoeopathic preparations 893 Homoeopathic preparations, arsenious trioxide for 895 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.1 Index Homoeopathic preparations, common stinging nettle for 895 Homoeopathic preparations, copper for 896 Homoeopathic preparations, garlic for 897 Homoeopathic preparations, herbal drugs for 893 Homoeopathic preparations, honey bee for 898 Homoeopathic preparations, hypericum for 898 Homoeopathic preparations, iron for 899 Homoeopathic preparations, mother tinctures for 894 Homoeopathic preparations, saffron for 900 Honey 5.1-2946 Honey bee for homoeopathic preparations 898 Hop strobile 1730 Human albumin injection, iodinated (125I) 827 Human albumin solution 1731 Human anti-D immunoglobulin 1732 Human anti-D immunoglobulin, assay of (2.7.13.) 205 Human anti-D immunoglobulin for intravenous administration 1733 Human antithrombin III, assay of (2.7.17.) 209 Human antithrombin III concentrate 1733 Human coagulation factor II, assay of (2.7.18.) 209 Human coagulation factor IX 1738 Human coagulation factor IX, assay of (2.7.11.) 204 Human coagulation factor VII 1734 Human coagulation factor VII, assay of (2.7.10.) 203 Human coagulation factor VIII 1736 Human coagulation factor VIII, assay of (2.7.4.) 194 Human coagulation factor VIII (rDNA) 1737 Human coagulation factor X, assay of (2.7.19.) 210 Human coagulation factor XI 1739 Human coagulation factor XI, assay of (2.7.22.) 212 Human fibrinogen 1740 Human hepatitis A immunoglobulin 1741 Human hepatitis B immunoglobulin 1741 Human hepatitis B immunoglobulin for intravenous administration 1741 Human insulin 1800 Human measles immunoglobulin 1742 Human normal immunoglobulin 1742 Human normal immunoglobulin for intravenous administration 1744 Human plasma for fractionation 1746 Human plasma (pooled and treated for virus inactivation) 1747 Human prothrombin complex 1748 Human rabies immunoglobulin 1750 Human rubella immunoglobulin 1751 Human tetanus immunoglobulin 1751 Human varicella immunoglobulin 1752 Human varicella immunoglobulin for intravenous administration 1753 Human von Willebrand factor, assay of (2.7.21.) 211 Hyaluronidase 1753 Hyaluronidasum 1753 Hydralazine hydrochloride 1754 Hydralazini hydrochloridum 1754 Hydrargyri dichloridum 1995 Hydrastis rhizoma 1683 Hydrochloric acid, concentrated 1755 Hydrochloric acid, dilute 1756 Hydrochlorothiazide 1756 Hydrochlorothiazidum 1756 Hydrocortisone 1757 Hydrocortisone acetate 1759 Hydrocortisone hydrogen succinate 1761 Hydrocortisoni acetas 1759 Hydrocortisoni hydrogenosuccinas 1761 Hydrocortisonum 1757 Hydrogenated arachis oil 1018 Hydrogenated castor oil 1197 Hydrogenated cottonseed oil 1370 Hydrogenated soya-bean oil 2475 Hydrogenated wool fat 2708 Hydrogenii peroxidum 30 per centum 1763 Hydrogenii peroxidum per centum 1762 Hydrogen peroxide solution (30 per cent) 1763 Hydrogen peroxide solution (3 per cent) 1762 Hydromorphone hydrochloride 1763 Hydromorphoni hydrochloridum 1763 Hydrous wool fat 2709 Hydroxocobalamin acetate 1765 Hydroxocobalamin chloride 1766 Hydroxocobalamini acetas 1765 Hydroxocobalamini chloridum 1766 Hydroxocobalamini sulfas 1767 Hydroxocobalamin sulphate 1767 Hydroxycarbamide 1768 Hydroxycarbamidum 1768 Hydroxyethylcellulose 5.1-2947 Hydroxyethylcellulosum .5.1-2947 Hydroxyethylis salicylas 1769 Hydroxyethylmethylcellulose 2018 Hydroxyethyl salicylate 1769 Hydroxyl value (2.5.3.) 127 Hydroxypropylbetadex 1771 Hydroxypropylbetadexum 1771 Hydroxypropylcellulose 1773 Hydroxypropylcellulosum 1773 Hydroxypropylmethylcellulose 1780 Hydroxypropylmethylcellulose phthalate 1781 Hydroxyzine hydrochloride 1774 Hydroxyzini hydrochloridum 1774 Hymecromone 1775 Hymecromonum 1775 Hyoscine butylbromide 1776 Hyoscine hydrobromide 1777 Hyoscini butylbromidum 1776 Hyoscini hydrobromidum 1777 Hyoscyamine sulphate 1778 Hyoscyamini sulfas 1778 Hyperici herba 2485 Hypericum 2485 Hypericum for homoeopathic preparations 898 Hypericum perforatum ad praeparationes homoeopathicas 898 Hypromellose 1780 Hypromellose phthalate 1781 Hypromellosi phthalas 1781 Hypromellosum 1780 General Notices (1) apply to all monographs and other texts 3065 I Ibuprofen 1785 Ibuprofenum 1785 Iceland moss 1787 ICH (5.8.) 551 Ichthammol 1787 Ichthammolum 1787 Identification (2.3.) 95 Identification and control of residual solvents (2.4.24.) 113 Identification of fatty oils by thin-layer chromatography (2.3.2.) 98 Identification of phenothiazines by thin-layer chromatography (2.3.3.) 99 Identification reactions of ions and functional groups (2.3.1.) 95 Idoxuridine 1788 Idoxuridinum 1788 Index EUROPEAN PHARMACOPOEIA 5.1 Iecoris aselli oleum A 1348 Iecoris aselli oleum B 1352 Ifosfamide 1789 Ifosfamidum 1789 Imipenem 1791 Imipenemum 1791 Imipramine hydrochloride 1792 Imipramini hydrochloridum 1792 Immunochemical methods (2.7.1.) 187 Immunoglobulin, animal, anti-T lymphocyte, for human use 1010 Immunoglobulin for intravenous administration, human hepatitis B 1741 Immunoglobulin for intravenous administration, human normal 1744 Immunoglobulin for intravenous administration, human varicella 1753 Immunoglobulin, human anti-D 1732 Immunoglobulin, human anti-D, assay of (2.7.13.) 205 Immunoglobulin, human anti-D, for intravenous administration 1733 Immunoglobulin, human hepatitis A 1741 Immunoglobulin, human hepatitis B 1741 Immunoglobulin, human measles 1742 Immunoglobulin, human normal 1742 Immunoglobulin, human rabies 1750 Immunoglobulin, human rubella 1751 Immunoglobulin, human tetanus 1751 Immunoglobulin, human varicella 1752 Immunoglobulin, test for anticomplementary activity of (2.6.17.) 170 Immunoglobulin, test for Fc function of (2.7.9.) 202 Immunoglobulinum anti-T lymphocytorum ex animale ad usum humanum 1010 Immunoglobulinum humanum anti-D 1732 Immunoglobulinum humanum anti-D ad usum intravenosum 1733 Immunoglobulinum humanum hepatitidis A 1741 Immunoglobulinum humanum hepatitidis B 1741 Immunoglobulinum humanum hepatitidis B ad usum intravenosum 1741 Immunoglobulinum humanum morbillicum 1742 Immunoglobulinum humanum normale 1742 Immunoglobulinum humanum normale ad usum intravenosum 1744 Immunoglobulinum humanum rabicum 1750 Immunoglobulinum humanum rubellae 1751 Immunoglobulinum humanum tetanicum 1751 Immunoglobulinum humanum varicellae 1752 Immunoglobulinum humanum varicellae ad usum intravenosum 1753 Immunosera ad usum veterinarium 575 Immunosera and vaccines, phenol in (2.5.15.) .131 Immunosera and vaccines, veterinary, evaluation of safety (5.2.6.) .5.1-2827 Immunosera and vaccines, veterinary, evaluation of the efficacy (5.2.7) 5.1-2829 Immunosera and vaccines, veterinary, evaluation of the safety of each batch (5.2.9.) 5.1-2830 Immunosera ex animale ad usum humanum 573 Immunosera for human use, animal 573 Immunosera for veterinary use 575 Immunoserum botulinicum 801 Immunoserum clostridii novyi alpha ad usum veterinarium 5.1-2865 Immunoserum clostridii perfringentis beta ad usum veterinarium 5.1-2866 Immunoserum clostridii perfringentis epsilon ad usum veterinarium 5.1-2867 3066 Immunoserum contra venena viperarum europaearum 806 Immunoserum diphthericum 801 Immunoserum gangraenicum (Clostridium novyi) 802 Immunoserum gangraenicum (Clostridium perfringens) 803 Immunoserum gangraenicum (Clostridium septicum) 804 Immunoserum gangraenicum mixtum 802 Immunoserum tetanicum ad usum humanum 805 Immunoserum tetanicum ad usum veterinarium 5.1-2868 Implants 5.1-2843 Impurities in substances for pharmaceutical use, control of (5.10.) 559 Indapamide 1793 Indapamidum 1793 Indicators, relationship between approximate pH and colour (2.2.4.) 27 Indii (111In) chloridi solutio 828 Indii (111In) oxini solutio 829 Indii (111In) pentetatis solutio iniectabilis 830 Indium (111In) chloride solution 828 Indium (111In) oxine solution 829 Indium (111In) pentetate injection 830 Indometacin 1794 Indometacinum 1794 Infectious bovine rhinotracheitis vaccine (live), freeze-dried 768 Infectious bronchitis vaccine (inactivated), avian 718 Infectious bronchitis vaccine (live), avian 720 Infectious bursal disease vaccine (inactivated), avian 722 Infectious bursal disease vaccine (live), avian 723 Infectious chicken anaemia vaccine (live) 769 Infectious encephalomyelitis vaccine (live), avian 725 Infectious laryngotracheitis vaccine (live), avian 727 Influenza vaccine (split virion, inactivated) 671 Influenza vaccine (surface antigen, inactivated) 673 Influenza vaccine (surface antigen, inactivated, virosome) 674 Influenza vaccine (whole virion, inactivated) 676 Infrared absorption spectrophotometry (2.2.24.) 37 Infusions .5.1-2842 Inhalanda 5.1-2843 Inhalation gas, krypton (81MKr) 833 Inhalation, preparations for 5.1-2843 Inhalation, preparations for : aerodynamic assessment of fine particles (2.9.18.) 5.1-2799 Injections 5.1-2841 Injections, gels for 5.1-2843 Injections or infusions, concentrates for .5.1-2842 Injections or infusions, powders for .5.1-2842 Inserts, ophthalmic 604 Insulin aspart 1795 Insulin, bovine 1797 Insulin, human 1800 Insulini biphasici iniectabilium 1802 Insulini isophani biphasici iniectabilium 1803 Insulini isophani iniectabilium 1803 Insulin injection, biphasic 1802 Insulin injection, biphasic isophane 1803 Insulin injection, isophane 1803 Insulin injection, soluble 1803 Insulini solubilis iniectabilium 1803 Insulini zinci amorphi suspensio iniectabilis 1811 Insulini zinci cristallini suspensio iniectabilis 1812 Insulini zinci suspensio iniectabilis 1811 Insulin lispro 1804 Insulin, porcine 1806 Insulin preparations, injectable 1808 Insulinum aspartum 1795 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.1 Index Insulinum bovinum 1797 Insulinum humanum 1800 Insulinum lisprum 1804 Insulinum porcinum 1806 Insulin zinc injectable suspension 1811 Insulin zinc injectable suspension (amorphous) 1811 Insulin zinc injectable suspension (crystalline) 1812 Interferon alfa-2 concentrated solution 1812 Interferon gamma-1b concentrated solution 1815 Interferoni alfa-2 solutio concentrata 1812 Interferoni gamma-1b solutio concentrata 1815 Interferons, assay of (5.6.) 533 int-rac-α-Tocopherolum 5.1-3023 int-rac-α-Tocopherylis acetas 5.1-3024 Intramammary preparations for veterinary use 606 Intraruminal devices 607 In vivo assay of poliomyelitis vaccine (inactivated) (2.7.20.) .210 Iobenguane (123I) injection 831 Iobenguane (131I) injection for diagnostic use 832 Iobenguane (131I) injection for therapeutic use 833 Iobenguani (123I) solutio iniectabilis 831 Iobenguani (131I) solutio iniectabilis ad usum diagnosticum 832 Iobenguani (131I) solutio iniectabilis ad usum therapeuticum 833 Iodinated (125I) human albumin injection 827 Iodinated povidone 2291 Iodinati (125I) humani albumini solutio iniectabilis 827 Iodine 1819 Iodine value (2.5.4.) 127 Iodum 1819 Iohexol 1819 Iohexolum 1819 Ionic concentration, potentiometric determination of using ion-selective electrodes (2.2.36.) 55 Ions and functional groups, identification reactions (2.3.1.) 95 Ion-selective electrodes, potentiometric determination of ionic concentration (2.2.36.) 55 Iopamidol 1822 Iopamidolum 1822 Iopanoic acid 1824 Iotalamic acid 1825 Ioxaglic acid 1826 Ipecacuanhae extractum fluidum normatum 5.1-2951 Ipecacuanhae pulvis normatus 1829 Ipecacuanhae radix 1829 Ipecacuanhae tinctura normata 5.1-2951 Ipecacuanha liquid extract, standardised 5.1-2951 Ipecacuanha, prepared 1829 Ipecacuanha root 1829 Ipecacuanha tincture, standardised 5.1-2951 Ipratropii bromidum 1831 Ipratropium bromide 1831 Iron (2.4.9.) 107 Iron for homoeopathic preparations 899 Irrigation, preparations for 622 Isoconazole 1833 Isoconazole nitrate 1834 Isoconazoli nitras 1834 Isoconazolum 1833 Isoelectric focusing (2.2.54.) .81 Isoflurane 1835 Isofluranum 1835 Isoleucine 1836 Isoleucinum 1836 Isomalt 1837 Isomaltum 1837 Isoniazid 1839 Isoniazidum 1839 Isophane insulin injection 1803 Isoprenaline hydrochloride 1839 Isoprenaline sulphate 1840 Isoprenalini hydrochloridum 1839 Isoprenalini sulfas 1840 Isopropyl alcohol 1841 Isopropylis myristas 5.1-2952 Isopropylis palmitas 5.1-2953 Isopropyl myristate 5.1-2952 Isopropyl palmitate 5.1-2953 Isosorbide dinitrate, diluted 1844 Isosorbide mononitrate, diluted 1845 Isosorbidi dinitras dilutus 1844 Isosorbidi mononitras dilutus 1845 Isotretinoin 1847 Isotretinoinum 1847 Isoxsuprine hydrochloride 1848 Isoxsuprini hydrochloridum 1848 Ispaghula husk 1849 Ispaghula seed 1850 Isradipine 1851 Isradipinum 1851 Itraconazole 1852 Itraconazolum 1852 Iuniperi aetheroleum 1863 Iuniperi pseudo-fructus 1862 Ivermectin 1854 Ivermectinum 1854 Ivy leaf 5.1-2954 General Notices (1) apply to all monographs and other texts 3067 J Javanese turmeric 2645 Java tea 1859 Josamycin 1860 Josamycini propionas 1861 Josamycin propionate 1861 Josamycinum 1860 Juniper 1862 Juniper oil 1863 K Kalii acetas .2273 Kalii bromidum 2273 Kalii carbonas 2274 Kalii chloridum 2275 Kalii citras .2275 Kalii clavulanas 2276 Kalii clavulanas dilutus .2278 Kalii dihydrogenophosphas 2280 Kalii hydrogenoaspartas hemihydricus 2280 Kalii hydrogenocarbonas 2281 Kalii hydrogenotartras 2282 Kalii hydroxidum 2283 Kalii iodidum 2283 Kalii metabisulfis 2284 Kalii natrii tartras tetrahydricus .2286 Kalii nitras 2284 Kalii perchloras .2285 Kalii permanganas 2286 Kalii sorbas .2287 Kalii sulfas 2288 Kanamycin acid sulphate 1867 Kanamycini monosulfas 1868 Kanamycini sulfas acidus 1867 Kanamycin monosulphate 1868 Kaolin, heavy 1869 Index EUROPEAN PHARMACOPOEIA 5.1 Kaolinum ponderosum 1869 Kelp 1869 Ketamine hydrochloride 1870 Ketamini hydrochloridum 1870 Ketobemidone hydrochloride 1871 Ketoconazole 1872 Ketoconazolum 1872 Ketoprofen 1874 Ketoprofenum 1874 Ketotifen hydrogen fumarate 1875 Ketotifeni hydrogenofumaras 1875 Knotgrass 1877 Krypton (81mKr) inhalation gas 833 Kryptonum (81mKr) ad inhalationem 833 L Labetalol hydrochloride 1881 Labetaloli hydrochloridum 1881 Lacca 2409 Lactic acid 1882 Lactic acid, (S)- 1883 Lactitol monohydrate 1883 Lactitolum monohydricum 1883 Lactobionic acid 1885 Lactose, anhydrous 1886 Lactose monohydrate 1887 Lactosum anhydricum 1886 Lactosum monohydricum 1887 Lactulose 1888 Lactulose, liquid 1890 Lactulosum 1888 Lactulosum liquidum 1890 Lanugo cellulosi absorbens 2681 Lanugo gossypii absorbens 1369 Lauroyl macrogolglycerides 1892 Lavandulae aetheroleum 1894 Lavandulae flos 1893 Lavender flower 1893 Lavender oil 1894 Lead in sugars (2.4.10.) 107 Lemon oil 1895 Leonuri cardiacae herba .2063 Leptospirosis vaccine (inactivated), bovine 730 Leptospirosis vaccine (inactivated), canine 740 Leucine 1897 Leucinum 1897 Leuprorelin 1898 Leuprorelinum 1898 Levamisole for veterinary use 1899 Levamisole hydrochloride 1900 Levamisoli hydrochloridum 1900 Levamisolum ad usum veterinarium 1899 Levistici radix 1932 Levocabastine hydrochloride 1902 Levocabastini hydrochloridum 1902 Levocarnitine .5.1-2959 Levocarnitinum 5.1-2959 Levodopa 1904 Levodopum 1904 Levodropropizine 1905 Levodropropizinum 1905 Levomenthol 1907 Levomentholum 1907 Levomepromazine hydrochloride 1908 Levomepromazine maleate 1908 Levomepromazini hydrochloridum 1908 Levomepromazini maleas 1908 Levomethadone hydrochloride 1909 Levomethadoni hydrochloridum 1909 3068 Levonorgestrel 1911 Levonorgestrelum 1911 Levothyroxine sodium 1912 Levothyroxinum natricum 1912 Lichen islandicus 1787 Lidocaine 1913 Lidocaine hydrochloride 1914 Lidocaini hydrochloridum 1914 Lidocainum 1913 Light liquid paraffin 2186 Light magnesium carbonate 1954 Light magnesium oxide 1958 Lime flower 1914 Limit test of particle size by microscopy (2.9.13.) 239 Limit tests (2.4.) 103 Limit tests, standard solutions for (4.1.2.) 426 Limit tests, standard solutions for (4.1.2.) 5.1-2818 Limonis aetheroleum 1895 Lincomycin hydrochloride 1915 Lincomycini hydrochloridum 1915 Lindane 1916 Lindanum 1916 Linen thread, sterile, in distributor for veterinary use 886 Lini oleum virginale 1918 Lini semen 5.1-2960 Linoleoyl macrogolglycerides .1917 Linseed 5.1-2960 Linseed oil, virgin 1918 Liothyronine sodium 1919 Liothyroninum natricum 1919 Liquid and semi-solid preparations, test for deliverable mass or volume (2.9.28.) 263 Liquid chromatography (2.2.29.) 43 Liquid extracts 571 Liquid glucose 1667 Liquid glucose, spray-dried 1668 Liquid lactulose 1890 Liquid maltitol 1969 Liquid paraffin 2187 Liquid preparations for cutaneous application 607 Liquid preparations for cutaneous application, veterinary 630 Liquid preparations for inhalation 5.1-2843 Liquid preparations for oral use 608 Liquid sorbitol (crystallising) 2471 Liquid sorbitol (non-crystallising) 2472 Liquid sorbitol, partially dehydrated 2473 Liquiritiae extractum fluidum ethanolicum normatum 1920 Liquiritiae radix 1921 Liquorice ethanolic liquid extract, standardised 1920 Liquorice root 1921 Lisinopril dihydrate 1922 Lisinoprilum dihydricum 1922 Lithii carbonas 1923 Lithii citras 1924 Lithium carbonate 1923 Lithium citrate 1924 L-Methionine ([11C]methyl) injection 834 L-Methionini ([11C]methyl) solutio iniectabilis 834 Lobeline hydrochloride 1925 Lobelini hydrochloridum 1925 Lomustine 1926 Lomustinum 1926 Loosestrife 1927 Loperamide hydrochloride 1928 Loperamide oxide monohydrate 1930 Loperamidi hydrochloridum 1928 Loperamidi oxidum monohydricum 1930 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.1 Index M Macrogol 15 hydroxystearate 1941 Macrogol 20 glyceroli monostearas 1942 Macrogol 20 glycerol monostearate 1942 Macrogol glycerol caprylocaprate 1941 Macrogol glyceroli caprylocapras 1941 Macrogola 1950 Macrogol cetostearyl ether 1943 Macrogolglyceridorum caprylocaprates 1173 Macrogolglyceridorum laurates 1892 Macrogolglyceridorum linoleates 1917 Macrogolglyceridorum oleates 2133 Macrogolglyceridorum stearates 2491 Macrogolglycerol cocoates 1947 Macrogolglycerol hydroxystearate 1948 Macrogolglyceroli cocoates 1947 Macrogolglyceroli hydroxystearas 1948 Macrogolglyceroli ricinoleas 1949 Macrogolglycerol ricinoleate 1949 Macrogoli 15 hydroxystearas 1941 Macrogoli aether cetostearylicus 1943 Macrogoli aether laurilicum 1944 Macrogoli aether oleicum 1945 Macrogoli aether stearylicus 1946 Macrogoli oleas 1944 Macrogoli stearas 1946 Macrogol lauryl ether 1944 Macrogol oleate 1944 Macrogol oleyl ether 1945 Macrogols 1950 Macrogol stearate 1946 Macrogol stearyl ether 1946 Magaldrate 1951 Magaldratum 1951 Magnesii acetas tetrahydricus 1952 Magnesii aspartas dihydricus 1953 Magnesii chloridum 4.5-hydricum 1955 Magnesii chloridum hexahydricum 1956 Magnesii glycerophosphas 1957 Magnesii hydroxidum 1957 Magnesii oxidum leve 1958 Magnesii oxidum ponderosum 1958 Magnesii peroxidum 1959 Magnesii pidolas 1960 Magnesii stearas 1961 Magnesii subcarbonas levis 1954 Magnesii subcarbonas ponderosus 1954 Magnesii sulfas heptahydricus 1962 Magnesii trisilicas 1963 Magnesium (2.4.6.) 104 Magnesium acetate tetrahydrate 1952 Magnesium and alkaline-earth metals (2.4.7.) 104 Magnesium aspartate dihydrate 1953 Magnesium carbonate, heavy 1954 Magnesium carbonate, light 1954 Magnesium chloride 4.5-hydrate 1955 Magnesium chloride hexahydrate 1956 Magnesium glycerophosphate 1957 Magnesium hydroxide 1957 Magnesium oxide, heavy 1958 Magnesium oxide, light 1958 Magnesium peroxide 1959 Magnesium pidolate 1960 Magnesium stearate 1961 Magnesium sulphate heptahydrate 1962 Magnesium trisilicate 1963 Maize oil, refined 1964 Maize starch .5.1-2965 Malathion 1965 Malathionum 1965 Maleic acid 1966 Malic acid 1966 Mallow flower 1967 Maltitol 1968 Maltitol, liquid 1969 Maltitolum 1968 Maltitolum liquidum 1969 Maltodextrin 1970 Maltodextrinum 1970 Malvae sylvestris flos 1967 Manganese sulphate monohydrate 1971 Mangani sulfas monohydricus 1971 Mannheimia vaccine (inactivated) for cattle 771 Mannheimia vaccine (inactivated) for sheep 772 Mannitol 1971 Mannitolum 1971 Maprotiline hydrochloride 1973 Maprotilini hydrochloridum 1973 Marek’s disease vaccine (live) 774 Marrubii herba 5.1-3039 Marshmallow leaf 1974 Marshmallow root 1975 Mass spectrometry (2.2.43.) 65 Mass uniformity of delivered doses from multidose containers (2.9.27.) 263 Mass uniformity of single-dose preparations (2.9.5.) 233 Mastic 1975 Masticabilia gummis medicata 601 Mastix 1975 Materials based on non-plasticised poly(vinyl chloride) for containers for dry dosage forms for oral administration (3.1.11.) 291 Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous solutions (3.1.10.) 289 Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion (3.1.14.) 296 Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components (3.1.1.1.) 269 Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components (3.1.1.2.) 272 Materials for containers for human blood and blood components (3.1.1.) 269 Materials used for the manufacture of containers (3.1.) 269 Matricariae aetheroleum 5.1-2967 General Notices (1) apply to all monographs and other texts 3069 Lorazepam 1931 Lorazepamum 1931 Loss on drying (2.2.32.) 50 Loss on drying of extracts (2.8.17.) 222 Lovage root 1932 Lovastatin 1933 Lovastatinum 1933 Low-molecular-mass heparins 1717 Lozenges and pastilles 613 Lozenges, compressed 613 Lubricant, silicone oil (3.1.8.) 287 Lupuli flos 1730 Lynestrenol 1935 Lynestrenolum 1935 Lysine acetate 5.1-2960 Lysine hydrochloride 1936 Lysini acetas 5.1-2960 Lysini hydrochloridum 1936 Lythri herba 1927 Index EUROPEAN PHARMACOPOEIA 5.1 Matricariae extractum fluidum 5.1-2966 Matricariae flos 5.1-2965 Matricaria flower .5.1-2965 Matricaria liquid extract 5.1-2966 Matricaria oil 5.1-2967 Maydis amylum 5.1-2965 Maydis oleum raffinatum 1964 Meadowsweet 1980 Measles immunoglobulin, human 1742 Measles, mumps and rubella vaccine (live) 678 Measles vaccine (live) 679 Measurement of consistency by penetrometry (2.9.9.) 235 Mebendazole 1981 Mebendazolum 1981 Meclozine hydrochloride 1982 Meclozini hydrochloridum 1982 Medicated chewing gum, drug release from (2.9.25.) 260 Medicated chewing gums 601 Medicated feeding stuffs for veterinary use, premixes for 617 Medicated foams 604 Medicated plasters 626 Medicated tampons 628 Medicated vaginal tampons 630 Medicinal air 929 Medicinal air, synthetic 932 Medium-chain triglycerides 2623 Medroxyprogesterone acetate 1983 Medroxyprogesteroni acetas 1983 Mefenamic acid 1984 Mefloquine hydrochloride 1986 Mefloquini hydrochloridum 1986 Megestrol acetate 1987 Megestroli acetas 1987 Meglumine 1988 Megluminum 1988 Mel 5.1-2946 Melaleucae aetheroleum .2534 Melilot 5.1-2970 Meliloti herba 5.1-2970 Melissae folium 1989 Melissa leaf 1989 Melting point - capillary method (2.2.14.) 32 Melting point - instantaneous method (2.2.16.) 33 Melting point - open capillary method (2.2.15.) 33 Menadione 1990 Menadionum 1990 Meningococcal group C conjugate vaccine 680 Meningococcal polysaccharide vaccine 682 Menthae arvensis aetheroleum partim mentholi privum .2050 Menthae piperitae aetheroleum 2206 Menthae piperitae folium .2205 Menthol, racemic 1991 Mentholum racemicum 1991 Menyanthidis trifoliatae folium 1115 Mepivacaine hydrochloride 1992 Mepivacaini hydrochloridum 1992 Meprobamate 1993 Meprobamatum 1993 Mepyramine maleate 1994 Mepyramini maleas 1994 Mercaptopurine 1995 Mercaptopurinum 1995 Mercuric chloride 1995 Mesalazine 1996 Mesalazinum 1996 Mesna 5.1-2971 Mesnum 5.1-2971 Mesterolone 1999 3070 Mesterolonum 1999 Mestranol 2000 Mestranolum 2000 Metacresol 2001 Metacresolum 2001 Metamizole sodium 2002 Metamizolum natricum .2002 Metformin hydrochloride .2003 Metformini hydrochloridum 2003 Methacrylic acid - ethyl acrylate copolymer (1:1) .2005 Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent 2005 Methacrylic acid - methyl methacrylate copolymer (1:1) 2006 Methacrylic acid - methyl methacrylate copolymer (1:2) 2007 Methadone hydrochloride 2007 Methadoni hydrochloridum 2007 Methanol and 2-propanol, test for (2.9.11.) 239 Methaqualone 2008 Methaqualonum 2008 Methenamine 2009 Methenaminum .2009 Methionine 2010 Methionine ([11C]methyl) injection, L- 834 Methionine, DL- 2010 Methioninum 2010 Methods in pharmacognosy (2.8.) 215 Methods of preparation of sterile products (5.1.1.) 445 Methotrexate 2011 Methotrexatum 2011 Methylatropine bromide 2014 Methylatropine nitrate 2015 Methylatropini bromidum 2014 Methylatropini nitras 2015 Methylcellulose 2016 Methylcellulosum 2016 Methyldopa 2016 Methyldopum 2016 Methylene blue 2028 Methylene chloride 2017 Methyleni chloridum 2017 Methylhydroxyethylcellulose 2018 Methylhydroxyethylcellulosum 2018 Methylis nicotinas 5.1-2972 Methylis parahydroxybenzoas 2013 Methylis parahydroxybenzoas natricum 2441 Methylis salicylas 2014 Methyl nicotinate 5.1-2972 Methyl parahydroxybenzoate 2013 Methylpentoses in polysaccharide vaccines (2.5.21.) 133 Methylphenobarbital 2019 Methylphenobarbitalum 2019 Methylprednisolone .2020 Methylprednisolone acetate 2022 Methylprednisolone hydrogen succinate 2024 Methylprednisoloni acetas 2022 Methylprednisoloni hydrogenosuccinas 2024 Methylprednisolonum 2020 Methylpyrrolidone, N- .2026 Methylrosanilinii chloridum 5.1-2973 Methylrosanilinium chloride 5.1-2973 Methyl salicylate 2014 Methyltestosterone 2027 Methyltestosteronum 2027 Methylthioninii chloridum 2028 Methylthioninium chloride 2028 Metixene hydrochloride 2029 Metixeni hydrochloridum .2029 Metoclopramide 2030 Metoclopramide hydrochloride 2031 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.1 Index Multidose containers, uniformity of mass of delivered doses (2.9.27.) 263 Mumps vaccine (live) 684 Mupirocin 2065 Mupirocin calcium 2067 Mupirocinum 2065 Mupirocinum calcicum 2067 Musci medicati 604 Mycobacteria (2.6.2.) 149 Mycoplasmas (2.6.7.) 149 Myristicae fragrantis aetheroleum 2123 Myrrh 2069 Myrrha .2069 Myrrhae tinctura .2069 Myrrh tincture 2069 Myrtilli fructus recens 1099 Myrtilli fructus siccus 1099 Myxomatosis vaccine (live) for rabbits 775 Metoclopramidi hydrochloridum 2031 Metoclopramidum 2030 Metoprololi succinas 2032 Metoprololi tartras 2034 Metoprolol succinate .2032 Metoprolol tartrate 2034 Metrifonate 2035 Metrifonatum 2035 Metronidazole 2037 Metronidazole benzoate 2038 Metronidazoli benzoas 2038 Metronidazolum 2037 Mexiletine hydrochloride 2039 Mexiletini hydrochloridum 2039 Mianserin hydrochloride 2041 Mianserini hydrochloridum 2041 Miconazole 2042 Miconazole nitrate 2043 Miconazoli nitras 2043 Miconazolum 2042 Microbiological assay of antibiotics (2.7.2.) 188 Microbiological examination of non-sterile products (test for specified micro-organisms) (2.6.13.) 156 Microbiological examination of non-sterile products (total viable aerobic count) (2.6.12.) 154 Microbiological quality of pharmaceutical preparations (5.1.4.) 449 Microcrystalline cellulose .1228 Micro determination of water (2.5.32.) 137 Microscopy, limit test of particle size (2.9.13.) 239 Midazolam 2045 Midazolamum 2045 Milk-thistle fruit 2046 Millefolii herba .2723 Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (5.2.8.) 463 Minocycline hydrochloride 2047 Minocyclini hydrochloridum .2047 Minoxidil .5.1-2974 Minoxidilum 5.1-2974 Mint oil, partly dementholised 2050 Mitomycin 2051 Mitomycinum 2051 Mitoxantrone hydrochloride 2053 Mitoxantroni hydrochloridum 2053 Modified-release capsules 600 Modified-release granules 606 Modified-release tablets 628 Molecular mass distribution in dextrans (2.2.39.) 57 Molgramostim concentrated solution 2054 Molgramostimi solutio concentrata 2054 Mometasone furoate 2057 Mometasoni furoas 2057 Monographs (1.4.) Morantel hydrogen tartrate for veterinary use 2059 Moranteli hydrogenotartras ad usum veterinarium 2059 Morphine hydrochloride .2060 Morphine sulphate 2061 Morphini hydrochloridum 2060 Morphini sulfas 2061 Moss, Iceland 1787 Mother tinctures for homoeopathic preparations 894 Motherwort .2063 Mouthwashes 612 Moxonidine 2064 Moxonidinum 2064 Mucoadhesive preparations 613 Mullein flower 2065 N Nabumetone 2073 Nabumetonum 2073 N-Acetyltryptophan 918 N-Acetyltryptophanum 918 N-Acetyltyrosine 920 N-Acetyltyrosinum 920 Nadolol 2074 Nadololum 2074 Nadroparin calcium 2075 Nadroparinum calcicum .2075 Naftidrofuryl hydrogen oxalate 2078 Naftidrofuryli hydrogenooxalas 2078 Nalidixic acid 2080 Naloxone hydrochloride dihydrate .2080 Naloxoni hydrochloridum dihydricum .2080 Naltrexone hydrochloride 5.1-2979 Naltrexoni hydrochloridum 5.1-2979 Naphazoline hydrochloride 2082 Naphazoline nitrate 2083 Naphazolini hydrochloridum 2082 Naphazolini nitras 2083 Naproxen 2084 Naproxenum 2084 Nasal drops and liquid nasal sprays 610 Nasalia 610 Nasal powders 611 Nasal preparations 610 Nasal preparations, semi-solid 611 Nasal sticks 611 Nasal washes 611 Natrii acetas trihydricus 2415 Natrii acetatis ([1-11C]) solutio iniectabilis 839 Natrii alendronas 2416 Natrii alginas 2417 Natrii amidotrizoas 2418 Natrii aminosalicylas dihydricus 2419 Natrii ascorbas .2420 Natrii benzoas 2421 Natrii bromidum 2422 Natrii calcii edetas 2422 Natrii caprylas 2423 Natrii carbonas anhydricus 5.1-3008 Natrii carbonas decahydricus .5.1-3008 Natrii carbonas monohydricus 5.1-3009 Natrii cetylo- et stearylosulfas 2426 Natrii chloridum 2428 Natrii chromatis (51Cr) solutio sterilis 840 Natrii citras .2429 Natrii cromoglicas 2429 General Notices (1) apply to all monographs and other texts 3071 Index EUROPEAN PHARMACOPOEIA 5.1 Natrii cyclamas 2430 Natrii dihydrogenophosphas dihydricus 2431 Natrii docusas 1471 Natrii fluoridi (18F) solutio iniectabilis 841 Natrii fluoridum 2432 Natrii fusidas 2433 Natrii glycerophosphas hydricus 2434 Natrii hyaluronas 2434 Natrii hydrogenocarbonas 2437 Natrii hydroxidum 2437 Natrii iodidi (123I) solutio iniectabilis 842 Natrii iodidi (131I) capsulae ad usum diagnosticum 843 Natrii iodidi (131I) solutio 844 Natrii iodidi (131I) solutio ad radio-signandum 845 Natrii iodidum 2438 Natrii iodohippurati (123I) solutio iniectabilis 845 Natrii iodohippurati (131I) solutio iniectabilis 846 Natrii lactatis solutio 2438 Natrii laurilsulfas 2440 Natrii metabisulfis 2441 Natrii molybdas dihydricus 2442 Natrii nitris .2443 Natrii nitroprussias 2443 Natrii perboras hydricus .2444 Natrii pertechnetatis (99mTc) fissione formati solutio iniectabilis 847 Natrii pertechnetatis (99mTc) sine fissione formati solutio iniectabilis 848 Natrii phosphatis (32P) solutio iniectabilis 849 Natrii picosulfas 2445 Natrii polystyrenesulfonas 2446 Natrii propionas 2447 Natrii salicylas 2449 Natrii selenis pentahydricus 2449 Natrii (S)-lactatis solutio .2439 Natrii stearas 2452 Natrii stearylis fumaras .2453 Natrii sulfas anhydricus 2454 Natrii sulfas decahydricus 2455 Natrii sulfis anhydricus .2455 Natrii sulfis heptahydricus 2456 Natrii thiosulfas 5.1-3009 Natrii valproas 2457 Near-infrared spectrophotometry (2.2.40.) 59 Neohesperidin-dihydrochalcone 2085 Neohesperidin-dihydrochalconum .2085 Neomycini sulfas .2086 Neomycin sulphate 2086 Neonatal piglet colibacillosis vaccine (inactivated) 776 Neonatal ruminant colibacillosis vaccine (inactivated) 778 Neostigmine bromide 2088 Neostigmine metilsulfate 2089 Neostigmini bromidum 2088 Neostigmini metilsulfas 2089 Netilmicini sulfas 2089 Netilmicin sulphate 2089 Nettle leaf 5.1-2980 Neurovirulence test for poliomyelitis vaccine (oral) (2.6.19.) 172 Neurovirulence test of live viral vaccines (2.6.18.) 172 Newcastle disease vaccine (inactivated) 779 Newcastle disease vaccine (live) 781 Nicergoline 2091 Nicergolinum 2091 Nicethamidum 2100 Nickel in polyols (2.4.15.) 108 Niclosamide, anhydrous 2092 Niclosamide monohydrate .2093 Niclosamidum anhydricum 2092 3072 Niclosamidum monohydricum 2093 Nicotinamide .2094 Nicotinamidum 2094 Nicotine 2095 Nicotine resinate 2096 Nicotinic acid 2097 Nicotini resinas .2096 Nicotinum 2095 Nifedipine 2098 Nifedipinum 2098 Nifuroxazide 2099 Nifuroxazidum .2099 Nikethamide 2100 Nimesulide 2101 Nimesulidum 2101 Nimodipine 2102 Nimodipinum 2102 Nitrazepam 2103 Nitrazepamum 2103 Nitrendipine 2104 Nitrendipinum 2104 Nitric acid 2105 Nitric oxide 2105 Nitrofural 2106 Nitrofuralum 2106 Nitrofurantoin 2107 Nitrofurantoinum 2107 Nitrogen 2108 Nitrogen determination by sulphuric acid digestion (2.5.9.) 129 Nitrogen determination, primary aromatic amino (2.5.8.) 129 Nitrogenii oxidum 2105 Nitrogenium 2108 Nitrogenium oxygenio depletum 2109 Nitrogen, low-oxygen 2109 Nitrogen monoxide and nitrogen dioxide in gases (2.5.26.) 135 Nitrous oxide 5.1-2981 Nitrous oxide in gases (2.5.35.) 141 Nizatidine 2111 Nizatidinum .2111 N-Methylpyrrolidone 2026 N-Methylpyrrolidonum 2026 N,N-Dimethylaniline (2.4.26.) 119 Nomegestrol acetate 2113 Nomegestroli acetas 2113 Nonoxinol 2114 Nonoxinolum .2114 Non-sterile products, microbiological examination of (test for specified micro-organisms) (2.6.13.) 156 Non-sterile products, microbiological examination of (total viable aerobic count) (2.6.12.) 154 Noradrenaline hydrochloride 2114 Noradrenaline tartrate 2115 Noradrenalini hydrochloridum 2114 Noradrenalini tartras 2115 Norcholesteroli iodinati (131I) solutio iniectabilis 836 Norcholesterol injection, iodinated (131I) 836 Norethisterone 2116 Norethisterone acetate 2117 Norethisteroni acetas 2117 Norethisteronum 2116 Norfloxacin 2118 Norfloxacinum 2118 Norgestrel 2119 Norgestrelum 2119 Normal immunoglobulin for intravenous administration, human 1744 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.1 Normal immunoglobulin, human 1742 Nortriptyline hydrochloride 2120 Nortriptylini hydrochloridum 2120 Noscapine 2121 Noscapine hydrochloride 2122 Noscapini hydrochloridum 2122 Noscapinum 2121 Nuclear magnetic resonance spectrometry (2.2.33.) 51 Nucleic acid amplification techniques (2.6.21.) 174 Nucleic acids in polysaccharide vaccines (2.5.17.) 132 Nutmeg oil 2123 Nystatin 2124 Nystatinum 2124 O O-Acetyl in polysaccharide vaccines (2.5.19.) 132 Oak bark 2129 Octoxinol 10 2129 Octoxinolum 10 2129 Octyldodecanol 2130 Octyldodecanolum 2130 Octyl gallate 2129 Octylis gallas 2129 Odour (2.3.4.) 99 Odour and taste of essential oils (2.8.8.) .216 Oenotherae oleum raffinatum 5.1-2921 Ofloxacin 2131 Ofloxacinum 2131 Oils rich in omega-3- acids, composition of fatty acids (2.4.29.) 121 Ointments 625 Oleae folium 2134 Olea herbaria 595 Oleic acid 2132 Oleoyl macrogolglycerides 2133 Oleyl alcohol 2134 Olivae oleum raffinatum 2135 Olivae oleum virginale 2136 Olive leaf 2134 Olive oil, refined 2135 Olive oil, virgin 2136 Olsalazine sodium 2137 Olsalazinum natricum 2137 Omega-3-acid ethyl esters 60 2140 Omega-3-acid ethyl esters 90 2142 Omega-3 acidorum esteri ethylici 60 2140 Omega-3 acidorum esteri ethylici 90 2142 Omega-3 acidorum triglycerida 2144 Omega-3-acids, composition of fatty acids in oils rich in (2.4.29.) 121 Omega-3-acids, fish oil rich in .1595 Omega-3-acid triglycerides 2144 Omeprazole 2146 Omeprazole sodium 2148 Omeprazolum 2146 Omeprazolum natricum 2148 Ondansetron hydrochloride dihydrate 2149 Ondansetroni hydrochloridum dihydricum 2149 Ononidis radix 2361 Opalescence of liquids, clarity and degree (2.2.1.) 23 Ophthalmica 602 Ophthalmic inserts 604 Opii pulvis normatus 2151 Opium crudum 2152 Opium, prepared 2151 Opium, raw 2152 Optical rotation (2.2.7.) 28 Oral drops 609 Oral powders 617 General Notices (1) apply to all monographs and other texts Index Oral solutions, emulsions and suspensions 609 Oral use, liquid preparations for 608 Orciprenaline sulphate 2154 Orciprenalini sulfas 2154 Oregano 2155 Organ preservation, solutions for .2458 Origani herba 2155 Orodispensible tablets 628 Oromucosal capsules 613 Oromucosal drops, oromucosal sprays and sublingual sprays 612 Oromucosal preparations 611 Oromucosal preparations, semi-solid 612 Oromucosal solutions and oromucosal suspensions 612 Orphenadrine citrate 2156 Orphenadrine hydrochloride 2157 Orphenadrini citras 2156 Orphenadrini hydrochloridum 2157 Orthosiphonis folium 1859 Oryzae amylum .2369 Osmolality (2.2.35.) 54 Other provisions applying to general chapters and monographs (1.2.) .5 Ouabain 2158 Ouabainum 2158 Oxaliplatin 2159 Oxaliplatinum 2159 Oxazepam 2162 Oxazepamum 2162 Oxeladin hydrogen citrate 2163 Oxeladini hydrogenocitras 2163 Oxfendazole for veterinary use 2164 Oxfendazolum ad usum veterinarium 2164 Oxidising substances (2.5.30.) 137 Oxolinic acid 2165 Oxprenolol hydrochloride 2166 Oxprenololi hydrochloridum 2166 Oxybuprocaine hydrochloride 2167 Oxybuprocaini hydrochloridum 2167 Oxybutynin hydrochloride 2168 Oxybutynini hydrochloridum 2168 Oxycodone hydrochloride .5.1-2987 Oxycodoni hydrochloridum 5.1-2987 Oxygen 2169 Oxygen (15O) 837 Oxygen-flask method (2.5.10.) 130 Oxygen in gases (2.5.27.) 136 Oxygenium 2169 Oxygenium (15O) 837 Oxymetazoline hydrochloride 2170 Oxymetazolini hydrochloridum 2170 Oxytetracycline dihydrate 2171 Oxytetracycline hydrochloride 2172 Oxytetracyclini hydrochloridum 2172 Oxytetracyclinum dihydricum 2171 Oxytocin 2174 Oxytocin bulk solution 2175 Oxytocini solutio 2175 Oxytocinum .2174 P Palmitic acid 2179 Pancreas powder 2179 Pancreatis pulvis 2179 Pancuronii bromidum 2182 Pancuronium bromide 2182 Pansy, wild (flowering aerial parts) .2700 Papaverine hydrochloride 2183 Papaverini hydrochloridum 2183 3073 Index EUROPEAN PHARMACOPOEIA 5.1 Papaveris rhoeados flos 2359 Paper chromatography (2.2.26.) 40 Paracetamol 2184 Paracetamolum 2184 Paraffin, hard 2186 Paraffin, light liquid 2186 Paraffin, liquid 2187 Paraffinum liquidum 2187 Paraffinum perliquidum 2186 Paraffinum solidum 2186 Paraffin, white soft 2187 Paraffin, yellow soft 2188 Parainfluenza virus vaccine (live), bovine, freeze-dried 732 Parainfluenza virus vaccine (live), canine 742 Paraldehyde 2189 Paraldehydum 2189 Parenteralia .5.1-2841 Parenteral preparations 5.1-2841 Parenteral preparations, test for extractable volume of (2.9.17.) 243 Parnaparin sodium 2189 Parnaparinum natricum 2189 Paroxetine hydrochloride hemihydrate 2190 Paroxetini hydrochloridum hemihydricum 2190 Particles, fine, aerodynamic assessment of in preparations for inhalation (2.9.18.) 5.1-2799 Particle size by microscopy, limit test of (2.9.13.) 239 Particulate contamination : sub-visible particles (2.9.19.) 253 Particulate contamination : visible particles (2.9.20.) 255 Parvovirosis vaccine (inactivated), canine 743 Parvovirosis vaccine (inactivated), porcine 787 Parvovirosis vaccine (live), canine 744 Passiflorae herba 2192 Passion flower 2192 Pastes 625 Pasteurella vaccine (inactivated) for sheep 783 Pastilles and lozenges 613 Patches, transdermal 616 Patches, transdermal, dissolution test for (2.9.4.) 231 Pefloxacini mesilas dihydricus 2193 Pefloxacin mesilate dihydrate 2193 Penbutololi sulfas 2195 Penbutolol sulphate 2195 Penetrometry, measurement of consistency (2.9.9.) 235 Penicillamine 2196 Penicillaminum 2196 Pentaerythrityli tetranitras dilutus 2198 Pentaerythrityl tetranitrate, diluted 2198 Pentamidine diisetionate 2199 Pentamidini diisetionas 2199 Pentazocine 5.1-2991 Pentazocine hydrochloride .5.1-2991 Pentazocine lactate 5.1-2992 Pentazocini hydrochloridum 5.1-2991 Pentazocini lactas 5.1-2992 Pentazocinum 5.1-2991 Pentobarbital 2201 Pentobarbital sodium 2202 Pentobarbitalum 2201 Pentobarbitalum natricum 2202 Pentoxifylline 2203 Pentoxifyllinum .2203 Pentoxyverine hydrogen citrate 2204 Pentoxyverini hydrogenocitras 2204 Peppermint leaf 2205 Peppermint oil 2206 Pepsini pulvis 2207 Pepsin powder 2207 3074 Peptide mapping (2.2.55.) 82 Peptides, synthetic, acetic acid in (2.5.34.) 141 Pergolide mesilate 2209 Pergolidi mesilas .2209 Perindopril tert-butylamine 2210 Peritoneal dialysis, solutions for 2212 Peroxide value (2.5.5.) 128 Perphenazine 2214 Perphenazinum 2214 Pertussis (acellular, component), diphtheria, tetanus, poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) 653 Pertussis, diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed) 656 Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) 657 Pertussis vaccine 685 Pertussis vaccine (acellular), assay of (2.7.16.) 208 Pertussis vaccine (acellular, component, adsorbed) 686 Pertussis vaccine (acellular, co-purified, adsorbed) 688 Pertussis vaccine (adsorbed) 690 Pertussis vaccine, assay of (2.7.7.) 197 Peru balsam 2215 Pessaries 629 Pessaries and suppositories, disintegration of (2.9.2.) 227 Pessaries and suppositories, resistance to rupture (2.9.24.) 258 Pesticide residues (2.8.13.) 218 Pethidine hydrochloride 2216 Pethidini hydrochloridum 2216 Pharmaceutical technical procedures (2.9.) 225 Pharmacognosy, methods in (2.8.) 215 Pharmacopoeial harmonisation (5.8.) 551 Phenazone 2217 Phenazonum 2217 Pheniramine maleate 2218 Pheniramini maleas 2218 Phenobarbital 2219 Phenobarbital sodium 2220 Phenobarbitalum 2219 Phenobarbitalum natricum 2220 Phenol 2221 Phenol in immunosera and vaccines (2.5.15.) 131 Phenolphthalein .2222 Phenolphthaleinum 2222 Phenolsulfonphthalein 2222 Phenolsulfonphthaleinum 2222 Phenolum 2221 Phenothiazines, identification by thin-layer chromatography (2.3.3.) 99 Phenoxyethanol 2223 Phenoxyethanolum 2223 Phenoxymethylpenicillin 5.1-2992 Phenoxymethylpenicillin potassium .5.1-2994 Phenoxymethylpenicillinum .5.1-2992 Phenoxymethylpenicillinum kalicum 5.1-2994 Phentolamine mesilate 2227 Phentolamini mesilas 2227 Phenylalanine 2228 Phenylalaninum 2228 Phenylbutazone .2229 Phenylbutazonum 2229 Phenylephrine 2231 Phenylephrine hydrochloride 2232 Phenylephrini hydrochloridum 2232 Phenylephrinum 2231 Phenylhydrargyri acetas .2232 Phenylhydrargyri boras .2233 Phenylhydrargyri nitras 2234 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 5.1 Index Phenylmercuric acetate 2232 Phenylmercuric borate 2233 Phenylmercuric nitrate 2234 Phenylpropanolamine hydrochloride 2234 Phenylpropanolamini hydrochloridum 2234 Phenytoin 2235 Phenytoin sodium 2236 Phenytoinum 2235 Phenytoinum natricum 2236 Pholcodine .2237 Pholcodinum 2237 Phosphates (2.4.11.) 108 Phosphoric acid, concentrated .2237 Phosphoric acid, dilute 2238 Phosphorus in polysaccharide vaccines (2.5.18.) 132 pH, potentiometric determination of (2.2.3.) 26 Phthalylsulfathiazole 2238 Phthalylsulfathiazolum 2238 Physical and physicochemical methods (2.2.) 23 Physostigmine salicylate .2239 Physostigmine sulphate 2240 Physostigmini salicylas 2239 Physostigmini sulfas 2240 Phytomenadione 2241 Phytomenadionum 2241 Phytosterol 2242 Phytosterolum 2242 Picotamide monohydrate .2243 Picotamidum monohydricum 2243 Pilocarpine hydrochloride 2244 Pilocarpine nitrate 2246 Pilocarpini hydrochloridum 2244 Pilocarpini nitras 2246 Pimozide 2247 Pimozidum .2247 Pindolol 2248 Pindololum .2248 Pipemidic acid trihydrate .2249 Piperacillin 2250 Piperacillin sodium 2252 Piperacillinum 2250 Piperacillinum natricum 2252 Piperazine adipate 2253 Piperazine citrate 2254 Piperazine hydrate 2255 Piperazini adipas 2253 Piperazini citras 2254 Piperazinum hydricum 2255 Piracetam 2256 Piracetamum 2256 Pirenzepine dihydrochloride monohydrate .2257 Pirenzepini dihydrochloridum monohydricum .2257 Piretanide 2258 Piretanidum 2258 Piroxicam 2259 Piroxicamum 2259 Piscis oleum omega-3 acidis abundans 1595 Pivampicillin 2261 Pivampicillinum 2261 Pivmecillinam hydrochloride .2262 Pivmecillinami hydrochloridum 2262 Plantae ad ptisanam 573 Plantae medicinales 572 Plantae medicinales ad praeparationes homoeopathicas 893 Plantae medicinales praeparatore 572 Plantaginis lanceolatae folium 2368 Plantaginis ovatae semen 1850 Plantaginis ovatae seminis tegumentum 1849 Plasma for fractionation, human 1746 Plasma, human (pooled and treated for virus inactivation) 1747 Plasma humanum ad separationem 1746 Plasma humanum collectum deinde conditum ad viros exstinguendos 1747 Plastic additives (3.1.13.) 293 Plastic containers and closures for pharmaceutical use (3.2.2.) 308 Plastic containers for aqueous solutions for parenteral infusion (3.2.2.1.) 309 Plastic containers for human blood and blood components, sterile (3.2.3.) 309 Plastic syringes, single-use, sterile (3.2.8.) 314 Pneumococcal polysaccharide conjugate vaccine (adsorbed) .5.1-2851 Pneumococcal polysaccharide vaccine 691 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed) 648 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis vaccine (adsorbed) 656 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed) 653 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis and haemophilus type b conjugate vaccine (adsorbed) 657 Poliomyelitis vaccine (inactivated) 692 Poliomyelitis vaccine (inactivated), in vivo assay of (2.7.20.) .210 Poliomyelitis vaccine (oral) 695 Poliomyelitis vaccine (oral), test for neurovirulence (2.6.19.) 172 Poloxamera .2264 Poloxamers 2264 Polyacrylate dispersion 30 per cent 2265 Polyacrylatis dispersio 30 per centum 2265 Poly(alcohol vinylicus) 2272 Polyamide 6/6 suture, sterile, in distributor for veterinary use 887 Polyamide suture, sterile, in distributor for veterinary use 886 Polyethyleneglycols 1950 Polyethylene terephthalate for containers for preparations not for parenteral use (3.1.15.) 298 Poly(ethylene terephthalate) suture, sterile, in distributor for veterinary use 887 Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations (3.1.7.) 285 Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations (3.1.5.) 279 Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations (3.1.4.) 278 Polygalae radix 2401 Polygoni avicularis herba 1877 Polymorphism (5.9.) 555 Polymyxin B sulphate .2266 Polymyxini B sulfas 2266 Polyolefines (3.1.3.) 274 Polyoxyl castor oil 1949 Polyoxyl hydrogenated castor oil 1948 Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations (3.1.6.) 282 Polysaccharide vaccines, hexosamines in (2.5.20.) 132 Polysaccharide vaccines, methylpentoses in (2.5.21.) 133 Polysaccharide vaccines, nucleic acids in (2.5.17.) 132 Polysaccharide vaccines, O-acetyl in (2.5.19.) 132 Polysaccharide vaccines, phosphorus in (2.5.18.) 132 Polysaccharide vaccines, protein in (2.5.16.) 131 Polysaccharide vaccines, ribose in (2.5.31.) 137 General Notices (1) apply to all monographs and other texts 3075 Index EUROPEAN PHARMACOPOEIA 5.1 Polysaccharide vaccines, sialic acid in (2.5.23.) 133 Polysaccharide vaccines, uronic acids in (2.5.22.) 133 Polysorbate 20 2267 Polysorbate 40 2268 Polysorbate 60 2269 Polysorbate 80 2270 Polysorbatum 20 .2267 Polysorbatum 40 .2268 Polysorbatum 60 .2269 Polysorbatum 80 .2270 Poly(vinyl acetate) 2271 Poly(vinyl alcohol) 2272 Poly(vinyl chloride), non-plasticised, materials based on for containers for dry dosage forms for oral administration (3.1.11.) 291 Poly(vinyl chloride), non-plasticised, materials based on for containers for non-injectable aqueous solutions (3.1.10.) 289 Poly(vinyl chloride), plasticised, empty sterile containers of for human blood and blood components (3.2.4.) 311 Poly(vinyl chloride), plasticised, materials based on for containers for aqueous solutions for intravenous infusion (3.1.14.) 296 Poly(vinyl chloride), plasticised, materials based on for containers for human blood and blood components (3.1.1.1.) 269 Poly(vinyl chloride), plasticised, materials based on for tubing used in sets for the transfusion of blood and blood components (3.1.1.2.) 272 Poly (vinyl chloride), plasticised, sterile containers of for human blood containing anticoagulant solution (3.2.5.) 312 Poly(vinylis acetas) .2271 Poppy petals, red 2359 Porcine actinobacillosis vaccine (inactivated) 784 Porcine influenza vaccine (inactivated) 785 Porcine insulin 1806 Porcine parvovirosis vaccine (inactivated) 787 Porcine progressive atrophic rhinitis vaccine (inactivated) 788 Porosity of sintered-glass filters (2.1.2.) 17 Potassium (2.4.12.) 108 Potassium acetate 2273 Potassium bromide 2273 Potassium carbonate 2274 Potassium chloride 2275 Potassium citrate .2275 Potassium clavulanate 2276 Potassium clavulanate, diluted .2278 Potassium dihydrogen phosphate 2280 Potassium hydrogen aspartate hemihydrate .2280 Potassium hydrogen carbonate 2281 Potassium hydrogen tartrate .2282 Potassium hydroxide .2283 Potassium iodide 2283 Potassium metabisulphite 2284 Potassium nitrate .2284 Potassium perchlorate 2285 Potassium permanganate .2286 Potassium sodium tartrate tetrahydrate 2286 Potassium sorbate 2287 Potassium sulphate 2288 Potato starch 2288 Potentiometric determination of ionic concentration using ion-selective electrodes (2.2.36.) 55 Potentiometric determination of pH (2.2.3.) 26 Potentiometric titration (2.2.20.) 35 Poultices 625 Pour-on preparations 631 3076 Povidone 2289 Povidone, iodinated 2291 Povidonum 2289 Povidonum iodinatum 2291 Powdered cellulose 1232 Powders and granules for oral solutions and suspensions 609 Powders and granules for syrups 610 Powders and tablets for rectal solutions and suspensions 624 Powders, ear 602 Powders, effervescent .617 Powders for cutaneous application .616 Powders for eye-drops and powders for eye lotions 603 Powders for inhalation 5.1-2845 Powders for injections or infusions 5.1-2842 Powders for oral drops 609 Powders, nasal .611 Powders, oral .617 Praeadmixta ad alimenta medicata ad usum veterinarium 617 Praeparationes ad irrigationem 622 Praeparationes buccales 611 Praeparationes homoeopathicas 893 Praeparationes insulini iniectabiles 1808 Praeparationes intramammariae ad usum veterinarium 606 Praeparationes intraruminales 607 Praeparationes liquidae ad usum dermicum 607 Praeparationes liquidae peroraliae 608 Praeparationes liquidae veterinariae ad usum dermicum 630 Praeparationes molles ad usum dermicum 624 Praeparationes pharmaceuticae in vasis cum pressu 622 Pravastatin sodium 2292 Pravastatinum natricum .2292 Prazepam 2293 Prazepamum 2293 Praziquantel 2294 Praziquantelum .2294 Prazosin hydrochloride 2295 Prazosini hydrochloridum 2295 Prednicarbate 2297 Prednicarbatum .2297 Prednisolone .2298 Prednisolone acetate .2299 Prednisolone pivalate 2301 Prednisolone sodium phosphate 2302 Prednisoloni acetas 2299 Prednisoloni natrii phosphas 2302 Prednisoloni pivalas 2301 Prednisolonum 2298 Prednisone .2303 Prednisonum 2303 Prekallikrein activator (2.6.15.) 168 Premixes for medicated feeding stuffs for veterinary use 617 Preparations for inhalation 5.1-2843 Preparations for inhalation : aerodynamic assessment of fine particles (2.9.18.) 5.1-2799 Preparations for irrigation 622 Pressurised pharmaceutical preparations 622 Prilocaine 2305 Prilocaine hydrochloride 2307 Prilocaini hydrochloridum 2307 Prilocainum 2305 Primaquine diphosphate 2308 Primaquini diphosphas .2308 Primary aromatic amino-nitrogen, determination of (2.5.8.) 129 Primary standards for volumetric solutions (4.2.1.) 435 See the information section on general monographs (cover pages) ... (1S,3R,4R,7R,9R,11R,15S,16R,17R,18S,19E,21E,25E,27E,29E ,31 E ,33 R ,35 S ,36 R ,37 S) -33 -[ (3- amino -3, 6-dideoxy-β- be examined in 25 ml of methanol R and dilute to 50 ml D-mannopyranosyl)oxy]-1 ,3, 4,7,9,11,17 ,37 -octahydroxy- 15, 16,... absorbance between 220 nm and 35 0 nm (2.2. 25) The solution shows absorption maxima at 230 nm, 291 nm, 3 05 nm 2124 25 - 35 100 → 0 → 100 35 - 45 100 45 - 50 → 100 100 → 50 - 55 100 Flow rate : 1.0 ml/min... ml with water R Mix 35 0 ml of this buffer solution with 650 ml of methanol R, Time (min) Mobile phase A (per cent V/V) Mobile phase B (per cent V/V) Comment - 15 55 45 isocratic 15 - 45 55 → 45