Pharmaceutical Aspects Of Accelerated Stability Studies
Year: 2024
Type: article
Abstract: One of the most crucial factors in the creation of novel medications and formulations is the stability studies of pharmaceuticals. Predicting the shelf life plays a crucial part in the creation of pharmaceutical products for all dosage forms. It is also used to provide label instructions and identify specific storage requirements. Before any pharmaceutical product is accepted and approved, stability tests that guarantee the product's quality, safety, and efficacy throughout its shelf life are thought to be necessary. These investigations must be carried out according to predetermined protocols that are followed by the WHO, ICH, and other organizations. To guarantee that pharmaceutical products remain safe, effective, and of high quality for the duration of their shelf lives, stability studies are a standard operating procedure are adhered to when it comes to pharmaceutical items. Evidence of how a drug product's quality varies over time under the impact of different environmental conditions is provided by stability testing. Pharmaceutical Product Stability Studies: Determine how long a pharmaceutical product can stay within specified parameters in a particular packaging system to preserve quality and provide the intended performance during retesting or expiration. This review article includes an introduction to stability studies, lists the many kinds of stability studies, and provides criteria for estimating a pharmaceutical product's shelf life.
Author: Ramya Teja Medarametla*1, K. Venkata Gopaiah2, J. N. Suresh Kumar3, R. Lakshmi Pravallika4, P. Mouli4, S. K. Harshad4, P. Nannesha4, P. Ravishankar Durga Prasad4
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6892990045
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