Scientech’s stability program includes the study of a product as it relates to factors that could affect its quality. For example, Scientech considers the interactions of API with excipients, container closure systems and packaging materials. In fixed-dose combination, Scientech also evaluates the interaction between two or more APIs.
The guidelines provided by the International Council on Harmonization (ICH) establish what is required for the Stability Data Packet for APIs and Finished Products.
Ensuring Product Quality Through Comprehensive Interaction and Environmental Testing
The purpose of stability testing is to provide information on how the quality of an API or FPP changes over time and/or under the influence of a variety of environmental factors, such as temperature, humidity and light.
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