Control of Genotoxic Impurities in Active Pharmaceutical Ingredients: A Review and Perspective-Reference-Cited by-同舟云学术

Control of Genotoxic Impurities in Active Pharmaceutical Ingredients: A Review and Perspective

Published:2010-03-10 Issue:4 Volume:14 Page:946-959
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Robinson Derek I.¹

Affiliation:

1. 38 Millbrook Court, Little Mill, Monmouthshire NP4 0HT, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op900341a

Reference74 articles.

1. ICH Guideline: Impurities in New Drug Substances Q3A,(R2);International Conference on Harmonisation, 2006.

2. ICH Guideline: Impurities in New Drug Products Q3B,(R2);International Conference on Harmonisation, 2006.

3. A recent FDA guideline (July 2009) on impurities in generic drugs would effectively reduce the qualification threshold to 1000 ppm or 1 mg/day for new impurities which were not present in the reference listed drugs.

4. An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals

5. Recent Developments in the Risk Assessment of Potentially Genotoxic Impurities in Pharmaceutical Drug Substances

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