The chemical stability of a drug substance in the solid state can be evaluated under various temperature and humidity conditions.
可在不同温度和湿度条件下评价固态原料药的化学稳定性。
In general, a drug substance should be evaluated under storage conditions (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture.
通常，原料药的评估应当在测试其热稳定性的存储条件下(包括合适的公差)进行。
For products that contain more than one drug substance, the compatibility of the drug substances with each other should also be evaluated.
对于含有多个原料药的制剂，还应讨论各原料药间的兼容性。
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