Document Detail

A quality evaluation strategy for multi-sourced active pharmaceutical ingredient (API) starting materials.
MedLine Citation:
PMID:  16621411     Owner:  NLM     Status:  MEDLINE    
Establishing appropriate impurity specifications for active pharmaceutical ingredient (API) starting materials is an important component of the commercialization and registration of an API. Multiple sources and routes of manufacture of starting materials and the capability of the API synthetic process for tolerating impurities introduced with starting materials must be understood. A strategy for purity method development and use test evaluation of starting materials to aid in establishing quality requirements is described. Phenyl methyl amino propanol (PMAP), a starting material that may be used for fluoxetine hydrochloride and atomoxetine hydrochloride, is used to illustrate the quality evaluation strategy. Knowledge of actual and potential synthetic routes was used to predict potential impurities and guide purity method development. Multiple analytical methods that were semi-orthogonal in the nature of impurity retention (ion-pairing, ion interaction and hydrophilic interaction chromatographic modes) along with use tests were investigated.
Peter F Gavin; Bernard A Olsen; David D Wirth; Kurt T Lorenz
Publication Detail:
Type:  Journal Article     Date:  2006-04-18
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  41     ISSN:  0731-7085     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2006 Jun 
Date Detail:
Created Date:  2006-05-30     Completed Date:  2006-08-02     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  1251-9     Citation Subset:  IM    
Analytical Sciences Research & Development, Eli Lilly & Company, Lilly Research Laboratories, Indianapolis, IN 46285, USA.
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MeSH Terms
Chemistry, Pharmaceutical / methods*
Chromatography, Liquid / methods
Drug Contamination
Evaluation Studies as Topic
Pharmaceutical Preparations / analysis*
Quality Control*
Reg. No./Substance:
0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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