English translation for "drug substance"
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- 药的本质
Related Translations:
- Example Sentences:
| 1. | 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。 | | 2. | 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。 | | 3. | 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。 | | 4. | 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。 | | 5. | 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。 | | 6. | Although this guidance does not specifically address the submission of analytical procedures and validation data for raw materials , intermediates , excipients , container closure components , and other materials used in the production of drug substances and drug products , validated analytical procedures should be used to analyze these materials 尽管本指南并不专门叙述原料,中间体,赋形剂,包装材料及原料药和制剂生产中所用的其它物料的分析方法及分析方法验证资料的递交,但是应该应用验证过的分析方法来分析检测这些物质。 |
- Similar Words:
- "drug store of tcm" English translation, "drug store whisky" English translation, "drug store, pharmacy" English translation, "drug storehouse" English translation, "drug study" English translation, "drug sundries" English translation, "drug superviser" English translation, "drug supervisory body" English translation, "drug supporting healthy energy" English translation, "drug suppository" English translation
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