STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS
Abstract
Stability studies of pharmaceutical products ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. Stability of a pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications. Stability studies are required to be conducted in a planned way following the guidelines issued by ICH, who and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been included in the present review
Keywords: stability testing, stability studies, stability, pharmaceutical products, international council for harmonisation
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DOI
https://doi.org/10.22270/jddt.v8i2.1564References
Bajaj S, Singla D, Sakhuja N, Stability Testing of Pharmaceutical Products, Journal of Applied Pharmaceutical Science. 2012; 02(03): 129-138
Singh S. Stability testing during product development in Jain NK Pharmaceutical product development CBS publisher and distributors. India, (2000) 272-293.
Kommanaboyina B., Rhodes CT. Trends in stability testing with Emphasis on Stability during Distribution and Storage. Drug Dev. Ind. Pharm. 1999; 25:857-867.
Rana A, Hari Kumar S. Manufacturing defects of tablets - a review. Journal of Drug Delivery and Therapeutics, 2013; 3(6):200-206. doi:10.22270/jddt.v3i6.722
Carstensen JT., Rhodes CT. Clin. Res. Drug Reg. Affairs. 1993; 10:177-185
Anderson G., Scott M. Determination of product shelf life and activation energy for five drugs of abuse. Clin. Chem. 1991; 37:398-402
WHO. Stability studies in a global environment. Geneva meeting working document QAS/05.146 with comments, (2004).
Mundhe A, Cocrystalization: an alternative approach for solid modification. Journal of Drug Delivery and Therapeutics, 2013; 3(4):166-172. doi:10.22270/jddt.v3i4.555
ICH Q1A (R2). Stability testing guidelines: Stability testing of new drug substances and products. ICH Steering Committee, 2003.
Grimm W. Extension of the international conference on harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones 3 and 4. Drug Dev. Ind. Pharm. 1998; 24:313-325
Ali J. Khar RK, Ahuja A. Dosage form and design.3rd ed. Delhi. Birla Publications Pvt. Ltd (2008) 100-123.
Cha J, Gilmor T, Lane P, Ranweiler JS. Stability studies in Handbook of modern pharmaceutical analysis. Separation Science and Technology. Elsevier (2001) 459-505.
Mischler PG. Developing Stability Protocols for Global Product Registrations-An Update. Presentation at International Seminar on Stability Testing: Design and Interpretation for International Registration, 13 and 14 February 2002, IBC Life Sciences, London.
Singh S, Bhutani H, Mariappan TT, Kaur H, Bajaj M, Pakhale SP. Behaviour of Uptake of Moisture by Drugs and Excipients under Accelerated Conditions of Temperature and Humidity in the Absence and the Presence of light. 1. Pure Anti-Tuberculosis Drugs and their Combinations. Int. J. Pharm. 2002; 245:37-44.
Bhutani H, Mariappan TT, Singh S. Behavior of Uptake of Moisture by Drugs and Excipients under Accelerated Conditions of Temperature and Humidity in the Absence and the Presence of light. Part 2. Packaged and Unpackaged anti-Tuberculosis drug products. Pharm. Technol. 2003; 27:44-52.
Shah D, Patel B, Shah C. Nanosuspension technology: a innovative slant for drug delivery system and permeability enhancer for poorly water soluble drugs. Journal of Drug Delivery and Therapeutics, 2015; 5(1):10-23. doi:10.22270/jddt.v5i1.995
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