摘要
当药品中所含的残留溶剂水平高于安全值时,残留溶剂对人体或环境将产生危害。ICH根据残留溶剂对人体健康和环境的危害程度将其分为四类,并规定了每种溶剂所允许的最大残留量。对残留溶剂的测定已越来越受到人们的重视。本文综述了气相色谱法在测定有机溶剂残留中的应用,包括直接进样法、顶空分析法和固相微萃取技术的应用,并对残留溶剂质控提出展望。
Objective If the presence of residual solvents in pharmaceuticals exceeds tolerance limits as suggested by safety data, they may be harmful to the human body or the environment. Results Solvents that are often used in the manufacturing of pharmaceuticals are divided into four classes in terms of their level of hazard to humans and the environment and regulated the level of each solvent by the International of Pharmaceuticals for Human Use （ ICH ）. The determination of residual solvents receives a great deal of attention. This article reviews the application of gas chromatography in residual solvents by direct？ injection, headspace and solidphase micro-extraction, and then we look ahead to the quality control of residual solvents.
出处
《中国实用医药》
2009年第33期230-232,共3页
China Practical Medicine
关键词
药品
残留溶剂
气相色谱法
Pharmaceutical
Residual solvent
Gas chromatography
