药物和内标的储备液稳定性应在室温下至少6小时评估。
The stability of stock solutions of drug and the internal standard should be evaluated at room temperature for at least 6 hours.
用于稳定性评估的分析物储备液应使用适当的已知浓度的溶剂制备。
Stock solutions of the analyte for stability evaluation should be prepared in an appropriate solvent at known concentrations.
如果储备液是在相关时期冷藏或冷冻的,稳定性应记录。
If the stock solutions are refrigerated or frozen for the relevant period, the stability should be documented.
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