usp溶剂残留中英文版.docVIP

467 溶剂残留 简介： INTRODUCTION This general chapter applies to existing drug substances, excipients, and products. All substances and products are subject to relevant control of solvents likely to be present in a substance or product. 本章节适用于现有的原料药， 辅料和制剂。 应对原料药或制剂产品中可能存在溶剂的所有原料及制剂产品进行控制。 Where the limits to be applied comply with those given below, tests for residual solvents are not generally mentioned in specific monographs, because the solvents employed may vary from one manufacturer to another. 当限值与下面提供的数值相符合， 残留溶剂的测试方法一般不会在专论中特别，因为不同制造商所使用的溶剂不同。 The objective of this general chapter is to provide acceptable amounts of residual solvents in pharmaceuticals for the safety of the patient. The chapter recommends the use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. 本指导原则旨在介绍药物中残留溶剂在保证人体安全条件下的 可接受量， 指导原则建议使用低毒的溶剂， 提出了一些残留溶剂毒理 学上的可接受水平。 For pharmacopeial purposes, residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The residual solvents are not completely removed by practical manufacturing techniques. Appropriate selection of the solvent for the synthesis of a drug substance or an excipient may enhance the yield, or determine characteristics such as crystal form, purity, and solubility. Therefore, the solvent may sometimes be a critical element in the synthetic process. This general chapter does not address solvents deliberately used as excipients, nor does it address solvates. However, the content of solvents in such products should be evaluated and justified. 药物中的残留溶剂在此定义为在原料药或辅料的生产中， 以及在 制剂制备过程中产生或使用的有机挥发性化合物， 它们在工艺中不能完全除尽。在合成原料药中选择适当的溶剂可提高产量或决定药物的性质，如结晶型、纯度和溶解度。因此有时溶剂是合成中非常关键的 因素。通用章节中并没有将溶剂作为辅料或溶剂化物。 然而在这些制 剂中的溶剂含量也应进行评估和判定。 Because residual solvents do not provide therapeutic benefit, they should be removed, to the extent possible, to meet ingredient an