Abstract

A CRUCIAL COMPONENT OF PHARMACEUTICAL QUALITY ASSURANCE IS DRUG STABILITY TESTING.

Gungan Shashwat Kerketta*

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Abstract

A crucial component of pharmaceutical quality assurance is drug stability testing. A crucial part of pharmaceutical quality control is stability testing, which makes sure that medications maintain their identity, safety, and efficiency over the course of their intended shelf lives in a variety of storage environments. Ensuring pharmaceutical products‘ safety, shelf life, and efficacy is imperative. Stability testing is done to determine how stable drug substances as well as products are in different environments, such as different temperatures, humidity levels, light levels, and pH levels. These studies aid in determining suitable storage conditions and expiration dates as well as valuable information about the possible deterioration of medications. There are 2 main types of stability testing: long-term and accelerated. Long-term studies are car ried out at room temperature and under normal storage conditions, while accelerated studies are conducted at higher temperatures and/or humidity to simulate aging over time. The type of stability testing that is conducted depends on the specific drug and its expected shelf life.

Keywords: International Conference of Harmonization guidelines, Stability studies, pharmaceutical products, Storage Conditions, Expiry Date, CPMP Guidelines, and ICH Guidelines.