Your stability testing program, including stability-indicating methods and acceptance criteria for each test to support the labeled storage conditions and expiry dates for your products.
你们的稳定性检测计划，包括每项检测的稳定性指示性方法和可接受标准以支持你们药品标示的存贮条件和有效期。
Objective: to predict the stability of lyophilized human thrombin by estimating the shelf life at different temperatures through accelerated storage test.
目的：为了在短时间内了解凝血酶的稳定性，通过加速试验对人凝血酶在不同温度下的贮存寿命进行了估算。
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。
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