DETERMINATION OF THE STABILITY AND SHELF LIFE OF ESCIN SUBSTANCE
Abstract
The quality and stability of drugs are closely related concepts. Drug stability is influenced by several factors, including temperature, light, and humidity. Determining the shelf life of a drug is a crucial concern for specialists in the field of Pharmacy. It involves studying the processes during drug extraction, storage, transportation, and other factors to establish proper storage conditions and expiration dates. Standard stability tests are carried out to determine storage conditions and expiration dates in accordance with industry standards. However, conducting accelerated tests for certain thermolabile drug substances and types, especially herbal medicines, is challenging, leading to reliance on natural (continuous) tests as the primary method for determining stability. Positive results from accelerated tests can suggest that stability can be maintained despite short-term deviations under normal storage conditions. Real-time continuous testing plays a crucial role in determining and validating optimal shelf life after drug registration. These tests are conducted under conditions that closely simulate actual storage conditions when the drug is in circulation. Based on these considerations, the shelf life of Escin was determined only through natural testing.
