Yashpal Singh Chauhan, Ravi Nex, Ghanshyam Sevak, Mahendra Singh Rathore
Yashpal Singh Chauhan*, Ravi Nex, Ghanshyam Sevak, Mahendra Singh Rathore
Geetanjali institute of Pharmacy, Udaipur, Raj., India.
Volume - 13,
Issue - 4,
Year - 2021
Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.
Cite this article:
Yashpal Singh Chauhan, Ravi Nex, Ghanshyam Sevak, Mahendra Singh Rathore. Stability Testing of Pharmaceutical Products. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(4):317-8. doi: 10.52711/0975-4377.2021.00052
Yashpal Singh Chauhan, Ravi Nex, Ghanshyam Sevak, Mahendra Singh Rathore. Stability Testing of Pharmaceutical Products. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(4):317-8. doi: 10.52711/0975-4377.2021.00052 Available on: https://rjpdft.com/AbstractView.aspx?PID=2021-13-4-9
1. ICH Q1A(R2). Stability testing guidelines: Stability testing of new drug substances and products. ICH Steering Committee, 2003:1-23.
2. Panda A, Kulkarni S., Tiwari R. Stability Studies: An Integral Part of Drug Development Process. International Journal of Pharmaceutical Research and Bio-Science, 2013;2;69-80.
3. Valerie Sautou, Methodological Guidelines for Stability Studies of Hospital Pharmaceutical Preparations, Part 1: Liquid preparation. October 2013,9-16.
4. Rao G., Goyal A., Development of Stability Indicating Studies for Pharmaceutical Products: An Innovative Step, International Journal of Pharmaceutical Chemistry and Analysis, 2016;3:110-116.
5. WHO. Stability studies in a global environment. Geneva meeting working document QAS/05.146 with comments, 2004.
6. Cha J, Gilmor T, Lane P, Ranweiler JS. Stability studies in Handbook of Modern Pharmaceutical Analysis. Separation Science and Technology. Elsevier, 2001;459-505.
7. Kommanaboyina B, Rhodes CT. Trends in stability Testing, with Emphasis on Stability During Distribution and Storage. Drug Development and Industrial Pharmacy. 1999;25:857-867.
8. Anderson G, Scott M. Determination of product shelf life and activation energy for five drugs of abuse. Clinical Chemistry. 1991;37:398-402.
9. Connors KA, Amidon GL, Kennon L. Chemical Stability of Pharmaceuticals-A Handbook for Pharmacists. John Wiley and Sons, New York: 1973;8-119.
10. Lachman L, Lieberman H. Kinetic principles and stability testing. The Theory and Practice of Industrial Pharmacy. CBS Publishers and Distributors Pvt Ltd, New Delhi, Fourth Edition 2013:1036-1072.
11. Bott RF, Oliveira WP. Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Development and Industrial Pharmacy. 2007;33:393-401.
12. International Conference on Harmonisation. ICH Q6A: Specifi cations: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances (http://www.ich.org/LOB/media/ MEDIA430.pdf).
13. Thorat P, Warad S, Solunke R, Sargar A, Bhujbal A, Shinde A. Stability Study of Dosage Form: An Inovative Step, World Journal of Pharmacy and Pharmaceutical Sciences, 2014;3:1031-1050.
14. Bajaj S, Singla D, Sakhuja N. Stability Testing of Pharmaceutical Products. Journal of Applied Pharmaceutical Science. 2012;2:129-138.
15. Singh S., Bakshi M. Guidance on conduct of stress test to determine inherent stability of drugs. Pharmaceutical Technology Asia, Special Issue, Sep. /Oct. 2000;24-36.
16. 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 Development and Industrial Pharmacy. 1998;24:313-325.
17. Ali J, Khar RK, Ahuja A. Dosage form and Design. Birla Publications Pvt. Ltd: Delhi,2008;100-123.
18. Cha J, Gilmor T, Lane P, Ranweiler JS. Stability studies in Handbook of Modern Pharmaceutical Analysis. Separation Science and Technology. Elsevier, 2001;459-505.
19. Guidance on variations to a prequalifi ed product dossier. In: WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Forty-fi rst report. Geneva, World Health Organization, 2007, Annex 6 (WHO Technical Report Series, No. 943).
20. International Conference on Harmonisation. ICH Q1A (R2): Stability testing of new drug substances and products. (http://www.ich.org/LOB/media/ MEDIA419.pdf).
21. Prequalifi cation Programme – Priority Essential Medicines. A United Nations Programme managed by WHO. Information for applicants (http://mednet3.who. int/prequal/).
22. Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996, Annex 5 (WHO Technical Report Series, No. 863).
23. Pokharana M, Vaishnav R, Goyal A, Shrivastava A. Stability testing guidelines of pharmaceutical products. Journal of Drug Delivery and Therapeutics. 2018 Mar 15;8(2):169-75.
24. Regional Guidelines on stability testing of active substances and pharmaceutical products for the WHO Eastern Mediterranean Region. August 2006. (http://www.emro.who.int/edb/media/pdf/EMRC5312En.pdf).
25. Further information can be found on the ICH homepage:http://www.ich.org/cache/ compo/276-254-1.html.
26. Guidelines on active pharmaceutical ingredient master fi le procedure. In: WHO Expert Committee on Specifi cations for Pharmaceutical Preparations.
27. Forty-second report. Geneva, World Health Organization, 2008, Annex 4 (WHO Technical Report Series, No. 948).
28. WHO guidelines for stability evaluation of vaccines. In: WHO Expert
29. Committee on Biological Standardization. Fifty-seventh report. Geneva, World Health Organization (WHO Technical Report Series, (in press))
30. (http://www.who.int/biologicals/publications/trs/areas/vaccines/stability/en/ index.html).
31. Schumacher P. 1972. Über eine für die Haltbarkeit von Arzneimitteln maßgebliche Klimaeinteilung [The impact of climate classifi cation on the stability of medicines]. Die Pharmazeutische Industrie, 34:481–483.
32. Grimm W. 1986. Storage conditions for stability testing (Part 2). Drugs Made in Germany, 29:39–47.
33. Grimm W. 1998. Extension of the International Conference on Harmonisation Tripartite Guidelines for stability testing of new drug substances and products to countries of Climatic Zones III and IV. Drug Development and Industrial Pharmacy, 24:313-325.
34. Zahn M. et al. 2006. A risk-based approach to establish stability testing conditions for tropical countries. Journal of Pharmaceutical Sciences, 95:946–965. Erratum: Journal of Pharmaceutical Sciences, 2007, 96:2177.
35. WHO good manufacturing practices: main principles for pharmaceutical products. In: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Volume 2, 2nd updated edition. Good manufacturing practices and inspection. Geneva, World Health Organization, 2007, Chapter 1.
36. Asean Guideline on stability study of drug product, 9th ACCSQ-PPWG Meeting, Philippines, 21–24 February 2005, version 22 February 2005.
37. Accelerated stability studies of widely used pharmaceutical substances under simulated tropical conditions. Geneva, World Health Organization, 1986 (WHO/PHARM/86.529).