Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development-Reference-Cited by-同舟云学术

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Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development

Published:2011-07-12 Issue: Volume: Page:279-335
ISSN:
Container-title:Characterization of Impurities and Degradants Using Mass Spectrometry
language:
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Author:

Pan Changkang,Liu Frances,Motto Michael

Publisher

John Wiley & Sons, Inc.

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/9780470921371.ch10/fullpdf

Reference135 articles.

1. US Food and Drug Administration 2003 Guidance for Industry, Q3A Impurities in New Drug Substances

2. US Food and Drug Administration 2006 Guidance for Industry, Q3B Impurities in New Drug Products

3. US Food and Drug Administration 1997 Guidance for Industry, Q3C Impurities: Residual Solvents

4. US Food and Drug Administration 2005 Draft Guidance for Industry, ANDAs: Impurities in Drug Substances

5. US Food and Drug Administration 2005 Draft Guidance for Industry, ANDAs: Impurities in Drug Products

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