Stability studies are a routine procedure for ensuring the maintenance of pharmaceutical product safety, quality and efficacy throughout the shelf life. These pharmaceutical products are followed by the guidelines issued by Regulatory bodies like ICH, WHO or other regulatory agencies. Stability testing provides evidence that the quality of a drug product under the influence of various environmental factors changes with time.
Stability Studies of Pharmaceutical Product Capacity of a pharmaceutical product in a given packaging system to remain within established specifications to maintain its Quality and deliver the desired Performance throughout the retest or expiration period. This review article includes introduction about stability studies, types of stability studies, and guidelines issued for shelf life estimation of pharmaceutical products.
Key Words: Stability, Types of Stability Studies, Stability Guidelines, Stability Testing.