Development and Stability of Forced Degradation Studies Indicating Different Brands of Metformin Drugs-Reference-Cited by-同舟云学术

Development and Stability of Forced Degradation Studies Indicating Different Brands of Metformin Drugs

Published:2021-10-05 Issue: Volume: Page:54-60
ISSN:2581-9429
Container-title:International Journal of Advanced Research in Science, Communication and Technology
language:en
Short-container-title:IJARSCT

Author:

Giri A. J.¹,Kingre Anjali D¹,Dhumal J. K.¹,Doifode P. R.¹,Jaybhaye Pratiksha¹,Tathe P. R²

Affiliation:

1. Samarth College of Pharmacy Deulgaon Raja, Buldhana, Maharashtra, India

2. Research Scholar, Shri JJT University, Rajasthan

Abstract

In present study, Accouring to specification of Indian pharmacopeia the content official limit of not less than (98.5%) and not more than (101.0%) of the lable amount our hypothesis was that when all different brands of metformin were expose to the different degradation parameters. The Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions.

Publisher

Naksh Solutions

Subject

General Medicine

Reference10 articles.

1. Ragine Maheswaran.FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA Submissions. Pharmaceutical Technology 2012; 36:73-80.

2. Bojana P, Markus D, Kappe CO. Microwave-assisted forced degradation using high-throughput microtiter platforms. Pharmaceut Biomed 2011; 56:867-873.

3. International conference on harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use, Validation of analytical procedures: Text methodology, (Q2 (R1) Geneva, 2005) 6-13.

4. Draft guidance analytical procedures and method validation, US food and drug administration, Centre for drugs and biologics, Department of Health and Human Services. http://www.fda.gov/cder/guidance/2396 dft.htm#111, 2000.

5. Brummer H et.al. How to approach a forced degradation study. Life Sci.Tech. Bull.31, 2011, 1-4.