Study of MPS Under Stressed Conditions


EOI: 10.11242/viva-tech.01.03.04

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Citation

Ms. Shwetali Kiran Churi, "Study of MPS Under Stressed Conditions", VIVA-IJRI Volume 1, Issue 3, Article 4, pp. 1-8, 2020. Published by Computer Engineering Department, VIVA Institute of Technology, Virar, India.

Abstract

This study is done to access the chemical stability of the candidate compound in the pharmaceuticals. Usually, it is performed at the preliminary stage in the process of drug development. Forced degradation/ stress testing is performed under accelerated environment. The experimental conditions cause the candidate compound to degrade under extreme conditions like acid and base hydrolysis, peroxide oxidation, photo-oxidation and thermal stability to identify the resultant degradation products. This helps to establish degradation pathways and thus intrinsic stability of a drug substance. The stability of product describes shelf life and storage conditions and helps in the selection of appropriate formulations and their suitable packaging. This is compulsory for regulatory documentation. The commonly used analytical approach for FDS is HPLC with UV and/ or MS but these techniques consume a lot of time and not provide high resolution to confirm the precise detection of degradation products. Use of UPLC with photodiode array and MS analysis supports the identification of degradation products and also reduces the time needed to evolve stability indicating methods.

Keywords

Pharmaceuticals, Degradation, Stability Hydrolysis, Oxidation.

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