Significance of Stability testing
Stability testing is a crucial process that involves assessing the durability and shelf-life of pharmaceutical products and active ingredients under various environmental conditions. It evaluates how formulations maintain their quality over time, ensuring safety and efficacy. This process encompasses a range of evaluations, including the physical, chemical, and microbiological stability of products, as well as the effects of temperature and humidity on their integrity. Overall, stability testing ensures that pharmaceuticals retain their expected performance throughout their designated shelf life.
Synonyms: Reliability testing, Robustness testing
The below excerpts are indicatory and do represent direct quotations or translations. It is your responsibility to fact check each reference.
The concept of Stability testing in scientific sources
Stability testing evaluates a drug or herbal product's quality over time under varying environmental conditions to determine its expiration date, ensuring the product's durability and maintaining its quality throughout its shelf life.
From: World Journal of Pharmaceutical Research
(1) Evaluation of a product's ability to maintain quality over time, particularly concerning moisture content and potency.[1] (2) The evaluation process to determine how the drug-resin complex maintains its properties over time under various conditions.[2] (3) The assessment of a drug's stability under different conditions to ensure safety and efficacy.[3] (4) The process of determining the stability of pharmaceutical products over time under various conditions.[4] (5) Evaluating the stability of new drug substances and products over time to ensure safety and efficacy.[5]
From: Journal of Ayurveda and Holistic Medicine
(1) The process of assessing the durability of a pharmaceutical product, including how it maintains quality under various conditions.[6]
From: AYU (Journal of Research in Ayurveda)
(1) Stability testing is the process of evaluating how the quality of a drug or herbal product varies with time under different environmental conditions to ascertain its expiration date.[7]
From: International Ayurvedic Medical Journal
(1) Stability testing is a complex set of procedures designed to provide evidence on how the quality of a drug substance or product varies over time under various environmental factors.[8]