PharmaTutor (August- 2014)
ISSN: 2347 - 7881
(Volume 2, Issue 8)
Received On: 06/06/2014; Accepted On: 15/06/2014; Published On: 01/08/2014
AUTHORS: Salma S. Quadri*, Lalit V. Sonwane, Bhagwat N. Poul, Sharada N. Kamshette
Department of Quality Assurance,
MSS’s Maharashtra College of Pharmacy, Nilanga,
Latur, Maharashtra, India.
Salmaq13@gmail.com
ABSTRACT:
The main contemporary goal of stability indicating methods is to provide information about condition for stress testing so as to establish the stability of drug substances and product. This paper reviews the regulatory aspects for development of stability indicating methods. SIMs are used to differentiate the API from its potential decomposition product. Regulatory guidance in ICH Q1A (R2) ICH Q3B (R2) Q6A and FDA 21 CFR section 211 requires validated stability indicating methods. Force degradation is required to demonstrate the specificity when developing SIMs and for this reason, it should be perform prior to implementing the stability studies. Force degradation of drug standard and excipients is carried out under different conditions to determine whether the analytical method is stability indicating. The approaches for the development of stability indicating method is discussed.
How to cite this article: SS Quadri, LV Sonwane, B Poul, S Kamshette; Review on Stability Indicating Assay Methods (SIAMs); PharmaTutor; 2014; 2(8); 16-31
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