Stability
Stability Data and Evaluation of Finished Pharmaceutical Products
Stability Studies: A Brief Introduction Stability studies are crucial for determining the shelf life and storage conditions of pharmaceutical products, ensuring their efficacy and safety throughout their lifespan. Long-term and accelerated studies are conducted to evaluate how products respond to various environmental conditions. Data from these studies help establish expiration ... Read More
Stability Requirements for Oral Solid Formulations in ANDA
When submitting an ANDA for a generic drug, one of the critical aspects is ensuring the product’s stability. The drug’s stability is a key factor in maintaining its safety, efficacy, and quality over its intended shelf life. Here are some key considerations: Long-term Stability: The generic drug product should retain ... Read More