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- The same drug substance may also exist in a noncrystalline (amorphous) form. 相同的原料药可能也会存在无定型。
- CQAs are generally associated with the drug substance, excipients,intermediates, and drug product. 一般来说，关键质量属性（CQA）是与药物活性成分，赋形剂，中间体和药品相关的。
- The new drug substance must meet its original specifications for crystalline form and/or solvation. 原料药必须符合有关晶形和溶剂化物的原定规格。
- The new drug substance must meet its original specifications for crystalline form and/or solation. 原料药必须符合有关晶形和溶剂化物的原定规格。
- Conditions used in manufacture and/or storage of the drug substance may result in the isolation or formation of a solvated or hydrated drug substance. 原料药制造和/或储存的条件可能会导致溶剂化或水合原料药的分离或形成。
- The principle and development of the CITP method and the automobile method of LDL-C were applied to the determination of vitro drug substance. 在体内药物分析方面,介绍了高效毛细管电泳的在线样品制备技术的原理、特点、及发展状况和LDL-C的自动化方法。
- Also, the rate and manner of freezing has been shown to have an affect on the physical form (polymorph) of the drug substance. 冷冻的速度和方式会影响药物组分的物理形态（同质异构）。
- AIM: To establish a microbiological method for determining the activity of ve rtilmicin in drug substance and injections. 目的:建立测定威替米星效价的方法并用于其原料药及注射液的质量控制。
- The total organic impurities for the drug product or drug substance is the sum of all impurities equal to or greater than their individual QL. 3、所有的没有记载的杂质，以及；4、总杂质。总有机杂质是指所有达到或超过其自身定量限度的杂质的总量。
- In addition to the drug substance, a medicinal product may contain excipients that may be organic molecules, polymers, or solids. 除了药物本身外，一个医药产品还可能含有有机分子、聚合物或固体赋形剂。
- In general, use of an overage of a drug substance to compensate for degradation during manufacture or a product’s shelf life, or to extend shelf life, is discouraged. 总体来说，不鼓励加入过量原料药以补偿生产过程或产品存贮期中原料药的降解，或用以延长保存期。
- VICH GL10:Impurities In New Veterinary Drug Substances Nov,1999. 中国兽药典（2005）版附录，农业部兽药典委员会。
- The analytical testing needed to document the suitability of reference standards is generally more extensive than that required by the bulk drug substance specifications. 证明标准品适应性的分析方法可以包括，通常比原料药质量标准要求的更全面。
- Summarise the quality and controls of the materials (e.g., raw materials, solvents pure and/or recovered, reagents, catalysts) used in the manufacture of the drug substance. 概述原料药生产中用到的物料质量和控制信息（如：原材料，纯溶剂或回收溶剂，试剂，催化剂）
- 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。
- Some types of bulk drug substance for salvage (e. G., Accumulated unused analytical samples, unused portions of lots, bulk returned from customers) may be processed in this fashion. 一些可再利用的散装原料药(如:累积的未使用的分析样品,未使用的批产品,由客户退回的产品)可以用同样的方法加工。
- 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。
- The emery is a hard metallic substance. 金刚砂是非常坚硬的金属物质。
- Such reworked drug substance batched should be subjected to additional analytical examination, as indicated above (i.e., for drug substance resulting from minor deviations of process conditions). 这些再加工的原料药应该接受如上所描述的（如：对稍微背离正常加工条件下所生产的原料药）额外分析检验。
- The nurse diluted the drug with saline water. 护士用生理盐水把药加以稀释。
