本文件的目的是描述试验计划和这些试验计划的不同操作方法，以便在开始分析协议之前，在规定的保存条件（温度、基质、光线、添加稳定剂（如适用）、保存类型等）下，定义和验证样品中物质的可接受稳定性长度（化学和物理化学分析）。不包括生物和微生物方法。 为了进行稳定性研究并实施其试验计划，必须有一种性能已被表征（重复性、中间精密度、真实性、准确度和不确定度）的分析方法。

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.