Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: A comprehensive review
Author:
Funder
National Institute of Pharmaceutical Education
International Islamic University Malaysia
Publisher
Elsevier BV
Subject
Pharmaceutical Science
Reference57 articles.
1. The role of degradant profiling in active pharmaceutical ingredients and drug products;Alsante;Adv. Drug Deliv. Rev.,2007
2. Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 2: safety considerations of impurities in pharmaceutical products and surveying the impurity landscape;Alsante;AAPS PharmSciTech.,2014
3. Baertschi, S.W., 2011. Pharmaceutical Stress Testing: Predicting Drug Degradation, Igarss 2014.
4. Stability testing of pharmaceutical products;Bajaj;J. Appl. Pharm. Sci.,2012
5. MSn, LC-MS-TOF and LC-PDA studies for identification of new degradation impurities of bupropion;Bansal;Biomed. Chromatogr.,2013
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