Degradation studies stability-indicating

Blessy, M., Patel, R.D., Prajapati, P.N., and Agrawal, Y.K. 2014. Development of forced degradation and stability indicating studies of drugs—A review, /. Pharm. Anal, 4(3) 159-165. 

The stress studies should demonstrate that impurities and degradants from the active ingredient do not interfere with the quantitation of the API [12]. Stress testing of the API, in addition to validating the stability-indicating power of the analytical method, can also help establish the degradation pathways and the intrinsic stability of the molecule [7]. 

Ruan, J., Tattersall, P, Lozano, R., and Shah, P. (2006). The role of forced degradation studies in stability indicating HPLC method developmerWm. Pharm. Rev., 9, 463. 

Bakshi M, Singh B, Singh A, Singh S. The ICH guidance in practice stress degradation studies on ornidazole and development of a validated stability-indicating assay. J Pharm Biomed Anal 2001 26 891-897. 

By the time the drug product is in phase III, studies should be included to demonstrate the inherent stability of the drug product, and the ability to detect potential degradation products should be available. The analytical method should use a validated stability-indicating assay. 

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