Application of Quality by Design Principles to Support Development of a Control Strategy for the Control of Genotoxic Impurities in the Manufacturing Process of a Drug Substance-Reference-Cited by-同舟云学术

Application of Quality by Design Principles to Support Development of a Control Strategy for the Control of Genotoxic Impurities in the Manufacturing Process of a Drug Substance

Published:2009-11-06 Issue:4 Volume:14 Page:993-998
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Cimarosti Zadeo¹,Bravo Fernando¹,Stonestreet Paul¹,Tinazzi Francesco¹,Vecchi Orsola¹,Camurri Giulio¹

Affiliation:

1. GlaxoSmithKline R&D, Chemical Development, Via Fleming, 4, Verona, Italy, and GlaxoSmithKline R&D, Chemical Development, Old Powder Mills, Near Leigh, Tonbridge, Kent TN11 9AN, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op900242x

Reference4 articles.

1. ICHQ8 Pharmaceutical Development, ICHQ9 Quality Risk Management, ICHQ10 Pharmaceutical Quality System.

2. Questions and answers to the follow-up to the contamination of Viracept (nelfinavir) with ethyl mesylate. EMEA/CHMP/375807/2008. London: European Medicines Agency, 2008.http://www.emea.europa.eu/human-docs/PDFs/EPAR/Viracept/Q&A_Viracept_37580708en.pdf(accessed 10 October 2009).

3. Mechanism and Processing Parameters Affecting the Formation of Methyl Methanesulfonate from Methanol and Methanesulfonic Acid: An Illustrative Example for Sulfonate Ester Impurity Formation

4. Amount of intermediate coming from 1 wt of the isolated intermediate3.

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