Impact of metal-induced degradation on the determination of pharmaceutical compound purity and a strategy for mitigation-Reference-Cited by-同舟云学术

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Impact of metal-induced degradation on the determination of pharmaceutical compound purity and a strategy for mitigation

Published:2011-04 Issue:5 Volume:54 Page:987-994
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Dotterer Sally K.,Forbes Robert A.,Hammill Cynthia L.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference17 articles.

1. Reviewer Guidance, Validation of Chromatographic Methods;Center for Drug Evaluation and Research (CDER),1994

2. Metal-catalyzed Oxidation of Organic Compounds;Sheldon,1981

3. Chapter 2 and 7 in Pharmaceutical Stress Testing,2007

4. A stress testing benchmarking study;Alsante;Pharm. Technol.,2003

5. ICH Harmonised Tripartite Guideline, Impurities in New Drug Substances, Q3A (R2),2006

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