drug substance meaning in English
药的本质
Examples
- The principles also apply to drug substances and drug products covered in type ii drug master files ( dmfs )
这些原则同样适用于二类dmf所涉及的原料药和制剂。 - Quantitative description ： the name and quantity of the drug substance and of each excipient in the finished product should be expressed both as amount per dosage unit and as amount per batch
定量描述：药品中所含半制品与赋型剂之名称与含量应以单位剂量与单位批示量来表示。 - Furthermore , specific recommendations for biological and immunochemical tests that may be necessary for characterization and quality control of many drug substances and drug products are beyond the scope of this guidance document
而且，许多原料药和制剂的界定和质量控制所需的生物和免疫化学检测并不在本指南的范围之内。 - The accuracy for drug substance may be determined with a reference substance or sample with known purity , or by comparing the result obtained by this method with the result obtained by another method of which the accuracy has been established
原料药可用已知纯度的对照品或样品进行测定,或用本法所得结果与已建立准确度的另一方法测定的结果进行比较。 - The qualitative and quantitative analytical procedures used to characterize a reference standard are expected to be different from , and more extensive than , those used to control the identity , strength , quality , purity , and potency of the drug substance or the drug product
用于界定标准品的定性和定量分析方法应当要不同于用于控制原料药或制剂的结构，剂量，质量，纯度和效力的分析方法，要比它们更深入。