HH-WAX毛细管柱 世界各国药典对药物残留溶剂测定

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世界各国药典对药物残留溶剂测定
世界各国药典对药物残留溶剂测定 详细信息：

名称：毛细管柱
固定相：聚乙二醇
规格：30m*0.25mm*0.25um
型号：HH-WAX
应用：世界各国药典对药物残留溶剂测定


 药物中的残留溶剂系指在原料药或辅料的生产中，以及在制剂过程中使用或产生的，但在工艺过程中未能完全去除的有机溶剂。根据国际化学品安全性纲要，美国环境保护机构、世界卫生组织等一些国际组织的研究结果，很多有机溶剂对环境、人体都有一定的危害，因此，为保障药物的用药安全，控制产品质量，需要进行有机溶剂残留量的研究和控制。

目前虽有陈立亚和陈苏伟等人发表了相关文章，但均未对各国药典中的残留溶剂测定法做系统的比较分析，浩瀚色谱（山东）应用技术开发有限公司通过对ChP2010、USP34、BP2011、EP7.0、JP15收载的残留溶剂种类、限度、色谱检测方法和系统适用性。

    类溶剂 人体致癌物、疑为人体致癌物或环境危害物 0.1以下(1,1,1)三氯乙烷除外（15.0）
        第二类溶剂 有非遗传致癌毒性或其他不可逆毒性、或其他严重的可逆毒性 0.5-50
        第三类溶剂 对人体低毒 50 以上
        第四类溶剂 尚无足够毒理学资料 





Drug Residual Solvent Determination in Pharmacopoeia of the World
Determination of drug residue solvents in pharmacopoeia around the world Details:

Name: capillary column
Stationary Phase: Polyethylene Glycol
Specifications: 30m*0.25mm*0.25um
Model: HH-WAX
Application: Determination of drug residual solvent in pharmacopoeia around the world


 Residual solvents in drugs refer to organic solvents that are used or produced in the production of APIs or excipients, and in the preparation process, but cannot be completely removed during the process. According to the International Chemical Safety Outline, the research results of some international organizations such as the US Environmental Protection Agency and the World Health Organization, many organic solvents have certain hazards to the environment and human body. Therefore, in order to ensure the safety of drugs and control product quality, Research and control of the residual amount of organic solvents is required.

At present, although Chen Liya and Chen Suwei have published relevant articles, they have not done a systematic comparative analysis of the residual solvent determination methods in the pharmacopoeia of various countries. Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. .0. Residual solvent types, limits, chromatographic detection methods and system applicability contained in JP15.

    Class 1 solvents Human carcinogens, suspected human carcinogens or environmental hazards Below 0.1 (1,1,1) Except for trichloroethane (15.0)
        Class II solvents have non-genetic carcinogenic toxicity or other irreversible toxicity, or other serious reversible toxicity 0.5-50
        The third type of solvent has low toxicity to human body above 50
        Class IV solvents No sufficient toxicological data