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Content DescriptionThe purpose of this document is to describe test plans and different operating methodologies of these test plans to define and verify the acceptable length of stability of a substance in a sample under specified conditions of preservation (temperature, matrix, light, addition of a stabilizer, where appropriate, type of preservation etc.) before starting analytical protocols (chemicals and physico-chemicals analysis). Biological and microbiological methods are excluded. It is necessary to have an analytical method with performances that have already been characterized (repeatability, intermediate precision, trueness, accuracy and uncertainty) in order to perform the stability study and implement its test plans. About ISOISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better. |
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