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We use cookies in order to design and continuously optimise the website. By using this website you agree to the use of cookies. Detailed information is provided in the data protection policy. Real-Time Aging programs provide the best data to determine shelf life and the effects of aging on materials.

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Each strength of a drug product, and each primary package and closure system in which it is distributed must be supported by stability testing. If you are contracting this work to a third party laboratory be sure that they can provide guidance to help navigate the regulatory and compendial guidelines, and you perform a quality system audit of their facility. A stability study is a program of testing that is designed to provide evidence on 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 light, and which enables recommended storage conditions, retest periods, and shelf lives to be established.

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