Rational Solvent Selection for Pharmaceutical Impurity Purge-Reference-Cited by-同舟云学术

Rational Solvent Selection for Pharmaceutical Impurity Purge

Published:2018-01-23 Issue:2 Volume:18 Page:1208-1214
ISSN:1528-7483
Container-title:Crystal Growth & Design
language:en
Short-container-title:Crystal Growth & Design

Author:

Abramov Yuriy A.¹^ORCID

Affiliation:

1. Pfizer Worldwide Research and Development, Groton, Connecticut 06340, United States

Publisher

American Chemical Society (ACS)

Subject

Condensed Matter Physics,General Materials Science,General Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.cgd.7b01748

Reference35 articles.

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

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

3. International Conference on Harmonisation (ICH).Guideline Q3C (R4): Impurities: Guidelines for Residual Solvents; 2009.

4. International Conference on Harmonisation (ICH). M7 Tripartite Guideline.Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Current Step 4 version; 23 June 2014.

5. Impurity Occurrence and Removal in Crystalline Products from Process Reactions

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