Stress Degradation Studies and Stability-Indicating Analytical Methods

Quality of any Active Pharmaceutical Ingredient (API) or drug product for patient compliance is directly depending on stability of drug. The ICH drug stability test guideline Q1A (R2) requires that analysis of stability samples should be done through the use of validated Stability indicating assay methods (SIAMs) that can detect the changes with time in the chemical, physical, or microbiological properties of the drug substance and drug product, and that are specific, so that the contents of active ingredient, degradation products, and other components of interest can be accurately measured without interference. A proactive approach in developing a SIAMs involve forced degradation at the early stages of development with the key degradation samples used in the method development process.

Autorentext

Dr. Mirza Shahed Baig is presently working as Associate Professor at MAET s Y. B. Chavan College of Pharmacy, Aurangabad, INDIA. He has completed his Doctoral degree from Dr. BAMU University, Aurangabad. He has total 13 years of professional experience. He has published more than 35 research papers in National and International Journals.