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Arunachalam A. et al. / Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 1(4), 2013, 184 - 195. Available online: October - December 184 Review Article ISSN: 2321-0923 STABILITY STUDIES: A REVIEW A. Arunachalam*1, M. Shankar2 *1Department of Pharmaceutics, Asmara College of Health Sciences, School of Pharmacy, Asmara, Eritrea, Africa. 2Department of Pharmaceutical Chemistry, Seven Hills College of Pharmacy, Tirupati, A P, 517562, India. INTRODUCTION INTRODUCTION Stability testing of pharmaceutical products is a complex set of procedures involving considerable cost, time consumption and scientific expertise in order to build in quality, efficacy and safety in a drug formulation. Scientific and commercial success of a pharmaceutical product can only be ensured with the understanding of the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan. The most important steps during the developmental stages include pharmaceutical analysis and stability studies that are required to determine and assure the identity, potency and ABSTRACT The stability studies is one of the very important parameters of pharmaceutical products. Stability assessment and shelf-life prediction is usually a major focus of a pharmaceutical scientist’s attention in the development of all dosage forms. It is important in the development of small molecule drug products as well, particularly given the importance of the physical state of the drug in determining stability characteristics. Stability testing is utilized for formulated product to prediction of shelf life, determine proper storage conditions and suggest labeling instructions. KEYWORDS Stability Studies, Shelf Life, Expirary Date, Storage Conditions, CPMP Guidelines and ICH Guidelines. Author for correspondence: A. Arunachalam, Department of Pharmaceutics, University of Asmara, Asmara College of Health Sciences, School of Pharmacy, Asmara, Eritrea, Africa. Email: [email protected]Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry Journal home page:
Arunachalam A. et al. / Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 1(4), 2013, 184 - 195. Available online: October - December 185 purity of ingredients, as well as those of the formulated products1. 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