(18.97.14.85)
[ij] [ij] [ij] 
Email id
 

Research Journal of Pharmacy and Technology
Year : 2009, Volume : 2, Issue : 4
First page : ( 621) Last page : ( 627)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.

Significance of Stability Studies on Degradation Product

Kushwaha Poonam*

Faculty of Pharmacy, Integral University, Lucknow-226026 (India)

*Corresponding Author E-mail: poonm1@yahoo.co.in

Online published on 8 April, 2013.

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.

Top

Keywords

degradation product, degradation mechanism, stability studies, stress testing, stability indicating assay.

Top

  
║ Site map ║ Privacy Policy ║ Copyright ║ Terms & Conditions ║ Page Rank Tool
861,024,136 visitor(s) since 30th May, 2005.
All rights reserved. Site designed and maintained by DIVA ENTERPRISES PVT. LTD..
Note: Please use Internet Explorer (6.0 or above). Some functionalities may not work in other browsers.