Résumé
The 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.
Informations générales
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État actuel: PubliéeDate de publication: 2022-02Stade: Norme internationale en cours d'examen systématique [90.20]
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Edition: 1
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Comité technique :ISO/TC 147/SC 6ICS :13.060.45
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Cycle de vie
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Actuellement
PubliéeISO/TS 5667-25:2022
Les normes ISO sont réexaminées tous les cinq ans
Stade: 90.20 (En cours d'examen)