Journal :   Research Journal of Pharmacy and Technology

Volume No. :   2

Issue No. :  4

Year :  2009

Pages :   621-627

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Significance of Stability Studies on Degradation Product

Address:   Poonam Kushwaha
Faculty of Pharmacy, Integral University, Lucknow-226026 (India)
*Corresponding Author

Drug degradation in formulations is a very complex and often unpredictable process. Degradation products arise during manufacture and storage of formulation. Common degradation products are derived from oxidation (by air, light, trace metal), hydrolysis, dehydration, adduct formation, dimerization, rearrangement, excipient reaction, and often the combination of these processes. For ensuring the stability of drug products over entire self life, various regulatory authorities requires, the stability data must be submitted with the NDA or ANDA. ICH and various other regulatory authorities have published guidelines on stability studies. Stress testing and stability indicating assays are also conducted to obtain stability data.
degradation product; degradation mechanism; stability studies; stress testing; stability indicating assay.
Poonam Kushwaha. Significance of Stability Studies on Degradation Product. Research J. Pharm. and Tech.2 (4): Oct.-Dec. 2009; Page 621-627.
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