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Sep 25, 2003 · Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes.
Aug 19, 2020 · Stability storage is the placement of samples into environmentally controlled chambers to determine how the quality of the substance or product varies with time under the influence of environmental factors such as temperature, humidity and light.
The purpose of a stability study is to establish, based on testing a minimum of three batches of the drug substance or product, a retest period or shelf life and label storage instructions applicable to all future batches manufactured and packaged under similar circumstances.
The purpose of stability testing is to provide evidence of how the quality of an API or FPP varies with time under the influence of a variety of environmental factors such as temperature, humidity and light.
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Stability studies should be conducted on product stored under normal storage conditions or, preferably, under exaggerated conditions.
Dec 9, 2008 · To properly evaluate the stability of a drug product, it is essential to determine the storage conditions under which the drug strength can be
ICH walk-in stability chambers, accelerated and bespoke storage conditions and assessments, and stability analysis for drug substance or drug product testing.
