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Vol. 14, Issue 7 (2025)

Overview on stability indicating methods in pharmaceutical Analysis

Author(s):
Suvarna G Bhokare, Pallavi Bhosle, Priya, Swarali Karanjeekar, Sonali Karpe and Shruti Karanda
Abstract:

To be accepted and approved, a pharmaceutical product must undergo stability testing that ensures its quality, safety, and efficacy are maintained during its shelf life. These investigations must be conducted in a systematic way in accordance with the guidelines provided by the ICH, WHO, and/or other authorities. This study provides a concise overview of stability testing guidelines, the importance of various methodologies for assessing the stability of pharmaceutical products, and other aspects related to pharmaceutical product stability.
Vegetable oil, lipids, and their biodiesels have the drawback of degrading in quality when exposed to oxygen, in contrast to diesel derived from petroleum. The fuel becomes unstable due to a variety of stability categories, such as oxidation, storage, and heat. The current study examines various kinds of stability measuring test techniques to identify the most efficient method for stability testing. This viewpoint states that while there are several methods to evaluate the stability of the biodiesel, two test methods are most likely to be used to ascertain its oxidative stability. These are ASTM2274 and 743Rancimattest. These two could be used in different ways, according to a comparison. The most popular methods for analysing thermal stability are Rancimattest, TGA/DTA, ASTMD6408-08, and D5304-06. The rancimat test is a crucial method for assessing the thermostability of oils, fats and biodiesel fuels.

Pages: 43-49  |  35 Views  23 Downloads


The Pharma Innovation Journal
How to cite this article:
Suvarna G Bhokare, Pallavi Bhosle, Priya, Swarali Karanjeekar, Sonali Karpe, Shruti Karanda. Overview on stability indicating methods in pharmaceutical Analysis. Pharma Innovation 2025;14(7):43-49.

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