Use of a Polymer Additive To Enhance Impurity Rejection in the Crystallization of a Pharmaceutical Compound-Reference-Cited by-同舟云学术

Use of a Polymer Additive To Enhance Impurity Rejection in the Crystallization of a Pharmaceutical Compound

Published:2017-09-14 Issue:10 Volume:21 Page:1493-1500
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Czyzewski Ann M.¹^ORCID,Chen Shuang¹,Bhamidi Venkateswarlu¹^ORCID,Yu Su¹,Marsden Ian¹,Ding Chen¹,Becker Calvin¹,Napier James J.¹

Affiliation:

1. Process Research & Development, ‡Structural Chemistry, AbbVie Inc., 1401 Sheridan Road, North Chicago, Illinois 60064, United States

Funder

AbbVie

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.7b00145

Reference26 articles.

1. Assuring quality of drugs by monitoring impurities☆

2. Pharmaceutical impurities—A mini-review

3. International Conference on Harmonization (ICH): Guidance for Industry Q3A - Impurities in New Drug Substances; Rev. 2, 2008, U.S. Department of Health and Human Services: FDA, CDER, CBER,http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073385.pdf(10/18/2016).

4. International Conference on Harmonization (ICH): Guidance for Industry Q3B - Impurities in New Drug Products; Rev. 2, 2006, U.S. Department of Health and Human Services: FDA, CDER, CBER,http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073389.pdf(10/18/2016).

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