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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。
Residual solvents can pose a hazard to the human body or the environment when the level of residual solvent contained in the drug is above a safe level. The ICH classifies the residual solvents into four categories according to their degree of harm to human health and the environment, and specifies the maximum allowable amount of each solvent. The determination of residual solvents has been more and more people’s attention. This review summarizes the applications of gas chromatography in the determination of organic solvent residues, including direct injection, headspace analysis and solid-phase microextraction. The quality control of residual solvents is also discussed.