期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 293, 期 1-2, 页码 101-125出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2004.12.013
关键词
drug stability; accelerated aging; hydrolysis; oxidation; shelf-life
Methods of rapidly and accurately assessing the chemical stability of pharmaceutical dosage forms are reviewed with respect to the major degradation mechanisms generally observed in pharmaceutical development. Methods are discussed, with the appropriate caveats, for accelerated aging of liquid and solid dosage forms, including small and large molecule active pharmaceutical ingredients. In particular, this review covers general thermal methods, as well as accelerated aging methods appropriate to oxidation, hydrolysis, reaction with reactive excipient impurities, photolysis and protein denaturation. (c) 2005 Elsevier B.V. All rights reserved.
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