Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances-Reference-Cited by-同舟云学术

Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances

Published:2008-11-13 Issue:2 Volume:13 Page:285-291
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Pierson Duane A.¹,Olsen Bernard A.¹,Robbins David K.¹,DeVries Keith M.¹,Varie David L.¹

Affiliation:

1. Analytical Sciences Research & Development and Chemical Process Research and Development, Eli Lilly & Company, Lilly Research Laboratories, Indianapolis, Indiana 46285, U.S.A.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op8002129

Reference33 articles.

1. International Conference on Harmonisation (ICH).Guideline Q3A(R): Impurities in New Drug Substances;February 2002.

2. European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP).Guideline on the limits of genotoxic impurities, CPMP/SWP/5199/02;London, U.K.,June 2006.

3. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity

4. Toxicological overview of impurities in pharmaceutical products☆

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