By Wei Pan

Published in: Pharmaceutical Outsourcing

Published on: August 9, 2018

Introduction: Stability is a critical quality attribute of pharmaceutical products and is a function of many factors, including the active drug substance itself, the excipients used within the formulation, the manufacturing process employed and the drug product’s container closure system. The purpose of stability testing is to provide evidence of how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and exposure to light, and to establish a retest period for the drug substance or a shelf-life for the drug product, as well as recommended storage conditions.1 Stability studies are conducted throughout all phases of the drug product’s life cycle; the purpose, regulatory requirements and technical challenges for each study vary depending on the product type, the phase of the program and the intended markets.

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