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

• المؤلفون الرئيسيون: Sengupta, Pinaki Ranjan, Chatterjee, Bappaditya, Tekade, Rakesh
• التنسيق: مقال
• اللغة: English; English; English
• منشور في: Elsevier B.V 2018
• الموضوعات: RS Pharmacy and materia medica
• الوصول للمادة أونلاين: 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

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...