0861 残留溶剂测定法

　　药品中的残留溶剂系指在原料药或辅料的生产中，以及在制剂制备过程中使用的，但在工艺过程中未能完全去除的有机溶剂。药品中常见的残留溶剂及限度见附表1，除另有规定外，第一、第二、第三类溶剂的残留限度应符合附表1中的规定；对其他溶剂，应根据生产工艺的特点，制定相应的限度，使其符合产品规范、药品生产质量管理规范（GMP）或其他基本的质量要求。

　　填充柱 以直径为0.18～0.25mm的二乙烯苯-乙基乙烯苯型高分子多孔小球或其他适宜的填料作为固定相。

　　编号:20231124006

　　型号:GDX-101填充柱

　　规格:2m*3MM，60-80目

　　使用温度:250°C

　　应用: yao典2025年版四部0521,0861，溶剂残留测定

　　适用于:岛津，安捷伦，赛默飞，瓦里安，布鲁克，PE等

　　0861 Residual solvent determination method

　　Residual solvents in drugs refer to organic solvents used in the production of raw materials or excipients, as well as in the preparation of formulations, but not completely removed during the manufacturing process. The common residual solvents and their limits in drugs are shown in Appendix 1. Unless otherwise specified, the residual limits of Class I, II, and III solvents should comply with the provisions in Appendix 1; For other solvents, corresponding limits should be established based on the characteristics of the production process to ensure that they comply with product specifications, Good Manufacturing Practice (GMP), or other basic quality requirements.

　　The filling column is fixed with a porous polymer ball with a diameter of 0.18-0.25mm, such as divinylbenzene-ethylvinylbenzene, or other suitable fillers.

　　Number: 20231124006

　　Model: GDX-101 filled column

　　Specification: 2m * 3MM, 60-80 mesh

　　Operating temperature: 250 ° C

　　Application: Yao Dian 2025 Edition Part 4 05210861, Solvent Residue Determination

　　Applicable to: Shimadzu, Agilent, Thermo Fisher, Varian, Brooke, PE, etc