Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms

被引：19

作者：

Alsante, Karen M. ^{[1
]}

Huynh-Ba, Kim ^{[2
]}

Baertschi, Steven W. ^{[3
]}

Reed, Robert A. ^{[4
]}

Landis, Margaret S. ^{[1
]}

Kleinman, Mark H. ^{[5
]}

Foti, Christopher ^{[1
]}

Rao, Venkatramana M. ^{[6
]}

Meers, Paul ^{[7
]}

Abend, Andreas ^{[8
]}

Reynolds, Daniel W. ^{[9
]}

Joshi, Biren K. ^{[9
]}

机构：

[1] Pfizer Global Res & Dev, Groton, CT 06340 USA

[2] Pharmalytik, Newark, DC USA

[3] Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46285 USA

[4] Celsion Corp, Lawrenceville, NJ USA

[5] GlaxoSmithKline, King Of Prussia, PA USA

[6] Bristol Myers Squibb, New Brunswick, NJ USA

[7] Rutgers State Univ, New Brunswick, NJ 08903 USA

[8] Merck, West Point, PA USA

[9] GlaxoSmithKline, Res Triangle Pk, NC USA

来源：

AAPS PHARMSCITECH | 2014年 / 15卷 / 01期

关键词：

CHEMICAL HYDROLYSIS; GAS-CHROMATOGRAPHY; EXCIPIENTS; STABILITY; PHOTOSTABILITY; LIPOSOMES; IDENTIFICATION; PHOSPHOLIPIDS; PHOTOTOXICITY; FORMULATIONS;

D O I：

10.1208/s12249-013-0047-x

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：198 / 212

页数：15

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