Tue, 19 Dec 2017

A Review on Industrial Applicable Stability Indicating Assay

Ramanlal N. Kachave1*, Priya Vinod Singh 1

1.Department of Pharmaceutics, Amrutvahini College of pharmacy, Sangamner- 422605, Maharashtra, India


ABSTRACT

In this article forced degradation is a degradation of drug product and new drug substance at different condition more severe accelerated condition. The forced degradation studies ensure chemical behavior of the molecule which in turn helps the development of formulation and packaging. The HPLC is an essential analytical tool in assessing drug and product stability. It insists various conditions like humidity, temperature, light and environmental factors which may affects the drug substance and drug product.

Keywords: Stress testing, Stability indicating assay, Development, Regulatory status.


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