Research Journal of Pharmacy and Technology

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0974-360X (Online)
0974-3618 (Print)


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Significance of Stability Studies on Degradation Product

Author(s): Poonam Kushwaha

Email(s): poonm1@yahoo.co.in

DOI: Not Available

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

Published In:   Volume - 2,      Issue - 4,     Year - 2009

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ABSTRACT:
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.


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Cite this article:
Poonam Kushwaha. Significance of Stability Studies on Degradation Product. Research J. Pharm. and Tech.2 (4): Oct.-Dec. 2009; Page 621-627.

Cite(Electronic):
Poonam Kushwaha. Significance of Stability Studies on Degradation Product. Research J. Pharm. and Tech.2 (4): Oct.-Dec. 2009; Page 621-627.   Available on: https://rjptonline.org/AbstractView.aspx?PID=2009-2-4-65


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RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

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Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal, devoted to pharmaceutical sciences. The aim of RJPT is to increase the impact of pharmaceutical research both in academia and industry, with strong emphasis on quality and originality. RJPT publishes Original Research Articles, Short Communications, Review Articles in all areas of pharmaceutical sciences from the discovery of a drug up to clinical evaluation. Topics covered are: Pharmaceutics and Pharmacokinetics; Pharmaceutical chemistry including medicinal and analytical chemistry; Pharmacognosy including herbal products standardization and Phytochemistry; Pharmacology: Allied sciences including drug regulatory affairs, Pharmaceutical Marketing, Pharmaceutical Microbiology, Pharmaceutical biochemistry, Pharmaceutical Education and Hospital Pharmacy.    
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