Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 10) doc
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 10) doc
... starting conditions for method development by usinginformation of similar separations503 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John ... and pharmaceutical information provides a basis for a significant increase of devel-opment efficiency.If analytical chemists from the various areas of drug development (drugmetabolism, preformulation, ... function of pH in that region. However, this is only true for theneutral form of the basic compound and the neutral form of the acidic com-pound. For basic compounds (or basic functionalities) the...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 8E) docx
... that was optimized by Drylab, a forced degrada-tion sample was run that was stressed at 50°C for 1 week in pH 1 diluent. Itwas noted that a major impurity was formed (Figure 8-49) and was determinedto ... isocratic conditions for deter-mining the most suitable pH for the method. The retention behavior of activeas a function of pH (isocratic) was determined. The best mobile-phase pH for further gradient ... canΠΠrLrLrr23024630460425.....-i.d.column-i.d.column-i.d.column2-i.d.column2==METHOD DEVELOPMENT APPROACHES 425be performed for further structural elucidation of the impurities. Deuteratedexperiments can be performed to support structural assignments.8.5.7 Case...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 8F) docx
... crystals that willdamage the seal over time. Therefore it is recommended to wash the HPLC system with acetonitrile/water (20:80) for at least 30min before the system isshut down to remove any potential ... of analysis is criticalto the success for fast and effective method development. The generalapproach for the method development for the separation of pharmaceutical compounds was discussed, ... R. Vivilecchia, UPLCTM—Acritical look at system/column performance and method transfer considerations for pharmaceutical analytes, HPLC 2005 Conference, Stockholm, Sweden, 2005.41. NIOSH Manual...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 1) docx
... arethree basic types of molecular forces: ionic forces, polar forces, and dispersiveforces. Each specific technique capitalizes on each of these specific forces:1. Polar forces are the dominant type ... normal-phase HPLC (see Chapter 5).2. Dispersive forces are employed in reversed-phase HPLC (see Chapter 4).3. Ionic forces are employed in ion-exchange HPLC (see Chapter 4,Section 4 .10). The ... performed toadequately control and monitor the quality of the prospective drug candidates,excipients, and final products. Effective and fast method development is of3 HPLC for Pharmaceutical Scientists, ...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 3) docx
... in HPLC are porous particles with averagediameters between 3 and 10µm. For most pharmaceutical applications, 3-µmparticle sizes are recommended. Porosity provides the surface area necessary for ... chromatographic performance of the column. The quality of an HPLC column is a subjective factor, which is dependent on the types of analytes andeven on the chromatographic conditions used for the evaluation ... (version 9.3).bLigand length calculated using ACD software for the distance between anchoring oxygen and foremost atom in all-trans conformation of correspondingligand.3.6.2.1 Types Modification...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 12) doc
... specific class for the drug candidate iscritical for future development of dosage forms.Different platforms are used for solubility measurements: UV; HPLC withUV detection; or HPLC with MS detection. ... suggeststhe necessity to formulate it in the form of salt. The reader is referred to ref-erence 46 for more information about the properties, selection, and use of saltforms for future drug development. ... multiple crystalforms of a commercial pharmaceutical and showed the importance of poly-morphic screening for all type of pharmaceutical dosage forms.When the exis-tence of polymorphism for new chemical...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 13) docx
... or microorganisms to screen their spectrum of605 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.baseline setup, ... treated as a whole (for more details see www.fda.gov; General Principles of Software Validation;Final Guidance for Industry and FDA Staff, January 11, 2002). The PQ isusually performed prior to ... chiral → chiral transforma-tions—could create critical issues in the interpretation of the metabolism andpharmacokinetics of the drug.Therefore, selective analytical methods for sep-arations...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 14) docx
... is highly unlikely that the synthetic process641 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.of blanks injected ... than ELSD [24]. HPLC DETECTORS 655Electrochemical detection can be utilized for compounds that are ionic orreadily oxidizable or reducible.Thus, this form of detection can be used for theanalysis ... prior to analysis byreversed-phase LC [21].14.4 HPLC DETECTORSThe detectors utilized for HPLC are designed to respond to the solute beingeluted. HPLC detectors can be classified into two broad...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 17) doc
... size for use with elevated pressures has therefore been anecessary and critical advancement for UHPLC [32, 33].The superior loadingcapacity of these materials makes them practical for most pharmaceutical analyses. ... instrumentation are steps toward making UHPLCa viable tool for pharmaceutical analysis.Two pressure regimes have been described: very-high pressure LC(VHPLC), for the pressure range of about 400–1500 ... be increased. However, due to the resolution765 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.Scientific, Darien,...
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Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 22) docx
... the two sets of crystals, the molecules are987 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.mobile phases ... the point of chiral carbon (Figure 22 -10). The hydroxyl group attached to the chiral carbon is in the same position for the d- and l-enantiomer placed for optimal hydrogen bonding to a 3-hydroxyl ... conformation with the N-TFA-α-amino acid isopropyl ester.(Reprinted from reference 36, with permission.)The introduction of the diamide derivatives for enantiomeric separationwas a step forward...
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