Photo Gallery

Login

Search

News & Updation

  • Updated Version
  • WJPPS introducing updated version of OSTS (online submission and tracking system), which have dedicated control panel for both author and reviewer. Using this control panel author can submit manuscript
  • Call for Paper
    • WJPPS  Invited to submit your valuable manuscripts for Coming Issue.
  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.
  •  
  • WJPPS Impact Factor
  • Its our Pleasure to Inform you that WJPPS Impact Factor has been increased from  7.454 to 7.632  due to high quality Publication at International Level

  • ICV
  • WJPPS Rank with Index Copernicus Value 84.65 due to high reputation at International Level

  • WJPPS AUGUST ISSUE PUBLISHED
  • AUGUST 2020 Issue has been successfully launched on 1 August 2020.

Abstract

FORCED DEGRADATION STUDIES: PRACTICAL APPROACH AND REGULATORY GUIDANCE

Jagruti Dolas*, Shailesh Jawarkar, Madhuri Game, Monika Jadhav, Kalyani Bhongade

ABSTRACT

Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop the stability indicating method that lead to quality stability data and to understand the degradation of new drug substance and drug product at condition more severe than accelerated condition. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation study. There is not much regulatory guidance available, which can provide step-by-step detail on stress testing. Therefore, in present review paper we described the extensive overview of forced degradation studied. ICH guideline demonstrates certain degradation condition like light, oxidation, dry heat, acidic, basic, hydrolysis etc. These studies are mainly used for the determination of stability of molecule under accelerated condition.

Keywords: Forced degradation, ICH, Degradation product, Degradation condition.


[Full Text Article]

Call for Paper

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Online Submission

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Email & SMS Alert

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More