Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review

Different regulatory guidelines recommend establishing stability profile of pharmaceuticals at the time of drug development. The expiry date, retesting period and storage conditions of active drugs or products are established through stability analysis. Several regulatory guidelines exist for stabil...

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Bibliographic Details

Main Authors:	Sengupta, Pinaki Ranjan, Chatterjee, Bappaditya, Tekade, Rakesh
Format:	Article
Language:	en en en
Published:	Elsevier B.V 2018
Subjects:	RS Pharmacy and materia medica
Online Access:	http://irep.iium.edu.my/63353/1/63353_Current%20regulatory%20requirements%20and%20practical.pdf http://irep.iium.edu.my/63353/7/63353_Current%20regulatory%20requirements%20and%20practical%20approaches_scopus.pdf http://irep.iium.edu.my/63353/13/63353_Current%20regulatory%20requirements%20and%20practical%20approaches%20for%20stability%20analysis%20of%20pharmaceutical%20products_WoS.pdf http://irep.iium.edu.my/63353/ https://www.sciencedirect.com/science/article/pii/S0378517318302187
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