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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Main Authors:	Sengupta, Pinaki Ranjan, Chatterjee, Bappaditya, Tekade, Rakesh
Format:	Article
Language:	English English English
Published:	Elsevier B.V 2018
Subjects:	RS Pharmacy and materia medica
Online Access:	http://irep.iium.edu.my/63353/ http://irep.iium.edu.my/63353/ http://irep.iium.edu.my/63353/ 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

id	iium-63353
recordtype	eprints
spelling	iium-633532019-03-13T05:30:52Z http://irep.iium.edu.my/63353/ Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review Sengupta, Pinaki Ranjan Chatterjee, Bappaditya Tekade, Rakesh RS Pharmacy and materia medica 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 stability testing of pharmaceuticals. Mostly, ICH stability guidelines are followed in practice. This guideline recommends to validate stability indicating method using forced degradation samples that contains all possible degradation impurities. ICH guidelines provide general recommendations for inclusion of stability indicating parameters in a stability testing protocol. However, those guidelines do not provide specific requirements and experimental methodology to be followed for stability studies. Due to this gap, often confusion arises in the scientific community in designing stability testing protocol. Therefore, significant variations are observed in reported literature in selection of stability indicating parameters. Procedural dissimilarity amongst reported stability studies is also evident. This review discusses the regulatory guidelines and procedures to follow in performing stability testing of pharmaceuticals. Scope of this review also includes recommendations on practical approaches for designing stability testing protocol to fulfill current regulatory requirements for drug substances and their formulations. Elsevier B.V 2018-04-06 Article PeerReviewed application/pdf en http://irep.iium.edu.my/63353/1/63353_Current%20regulatory%20requirements%20and%20practical.pdf application/pdf en http://irep.iium.edu.my/63353/7/63353_Current%20regulatory%20requirements%20and%20practical%20approaches_scopus.pdf application/pdf en http://irep.iium.edu.my/63353/13/63353_Current%20regulatory%20requirements%20and%20practical%20approaches%20for%20stability%20analysis%20of%20pharmaceutical%20products_WoS.pdf Sengupta, Pinaki Ranjan and Chatterjee, Bappaditya and Tekade, Rakesh (2018) Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review. International Journal of Pharmaceutics, 543 (1). pp. 328-344. ISSN 0378-5173 https://www.sciencedirect.com/science/article/pii/S0378517318302187 10.1016/j.ijpharm.2018.04.007
repository_type	Digital Repository
institution_category	Local University
institution	International Islamic University Malaysia
building	IIUM Repository
collection	Online Access
language	English English English
topic	RS Pharmacy and materia medica
spellingShingle	RS Pharmacy and materia medica Sengupta, Pinaki Ranjan Chatterjee, Bappaditya Tekade, Rakesh Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
description	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 stability testing of pharmaceuticals. Mostly, ICH stability guidelines are followed in practice. This guideline recommends to validate stability indicating method using forced degradation samples that contains all possible degradation impurities. ICH guidelines provide general recommendations for inclusion of stability indicating parameters in a stability testing protocol. However, those guidelines do not provide specific requirements and experimental methodology to be followed for stability studies. Due to this gap, often confusion arises in the scientific community in designing stability testing protocol. Therefore, significant variations are observed in reported literature in selection of stability indicating parameters. Procedural dissimilarity amongst reported stability studies is also evident. This review discusses the regulatory guidelines and procedures to follow in performing stability testing of pharmaceuticals. Scope of this review also includes recommendations on practical approaches for designing stability testing protocol to fulfill current regulatory requirements for drug substances and their formulations.
format	Article
author	Sengupta, Pinaki Ranjan Chatterjee, Bappaditya Tekade, Rakesh
author_facet	Sengupta, Pinaki Ranjan Chatterjee, Bappaditya Tekade, Rakesh
author_sort	Sengupta, Pinaki Ranjan
title	Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
title_short	Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
title_full	Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
title_fullStr	Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
title_full_unstemmed	Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
title_sort	current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review
publisher	Elsevier B.V
publishDate	2018
url	http://irep.iium.edu.my/63353/ http://irep.iium.edu.my/63353/ http://irep.iium.edu.my/63353/ 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
first_indexed	2023-09-18T21:29:52Z
last_indexed	2023-09-18T21:29:52Z
_version_	1777412438296100864

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

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