FORCED DEGRADATION STUDY – A NEW APPROACH FOR STRESS TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTSAbstract
Forced degradation studies are a vital tool in pharmaceutical research and development to predict long-term stability. Stress studies should be performed in method development to know drug behavior but can also be performed with method validation for regulatory filling predict stability, and measure impurities. It is especially valuable when little data is free about potential degradation products. Forced degradation studies may help encourage drug advancement in regions like formulation development, manufacturing, and packaging, in which information on substance conduct can be utilized to improve a medication item. Hence it is important to realize the purity profile and conduct of a medication substance under various natural conditions. For stable formulation development, comprehension of synthetic conduct forced degradation pathways and degradants of drug substance and drug product is very important. Therefore, by using different regulatory guidelines in the present review paper, we described the broad overview of forced degradation studies by determining the system to perform stress studies & its methods for isolation and identification of degradation.
A. K. Mullani * and P. I. Nargatti
Annasaheb Dange College of Pharmacy, Ashta, Walwa, Sangli, Maharashtra, India.
30 April 2020
16 March 2021
18 March 2021
01 May 2021