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- 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。
- Bulk substances (e.g., drug substances, impurities, excipients) should be stored in opaque nonreactive containers. 而像原料药，杂质，赋形剂等，则应当要保存在不透明的惰性容器中。
- 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。
- However, drug substances from different suppliers may have different impurity profiles that are not addressed by the compendial test procedure. 然而，不同供应商的原料药可能有不同的杂质情况，这些未用药典方法进行叙述。
- Key accountabilities: 1. Plan and execute preformulation studies for drug substances including but not limited to determ...... ... 公司名称：上海药明康德新药开发有限公司工作地点：上海市浦东新区发布时间：2009-7-30
- Cambrex has extensive experience developing process to manufacture drug substances for clients use in tox. studies, clinical studies and commercial supply - from grams to tons. 其细胞培养产品主要有细胞培养基和生长的普通培养基，无血清、无蛋白培养基，特殊细胞的专用培养基，培养用的血清、生长因子、试剂等。
- For drug substances under the proision of ParagrapH 1 of Article 2 hereof, long-term stability data and stressed condition stability data shall be submitted. 对于本法第2条第1段规定的原料药,应提交长期稳定性资料和影响因素稳定性数据。
- This guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle. 本指南适用于药品生产周期中的原料药和制剂，包括生物技术的，生物的产品。
- USP Reference Standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators. USP标准品是高度确认了的原料药，赋型剂，可报告的杂质，降解物，药典试剂，和性能校准器的样品
- For drug substances that are proteins, see the "CRC Handbook of Biochemistry and Molecular Biology," "Methods in Enzymology," and related monographs for how protein properties may be described. 对于蛋白质原料药，参见：“CRC生物化学和分子生物学手册” “酶学方法”和有关描述蛋白质特性的专论。
- 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 nurse diluted the drug with saline water. 护士用生理盐水把药加以稀释。
- 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）。
- Substances consist of small particles called molecules. 物质是由叫做分子的微粒组成的。
- 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。
