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The U.S. Pharmacopeia (USP) defines stability of pharmaceutical products as the extent to which a product retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of manufacture. Stability is determined by evaluation of the quality parameters with time under the influence of a variety of environmental factors such as temperature, humidity, and light. This article focuses on the stability and shelf life of pharmaceutical drug products. Keywords: pharmaceutical products; stability; quality parameters; shelf life; U.S. pharmacopeia (USP) |
