美国药监局实行FDA认证,并要求药品进入美国市场前,必须进行文件注册。在DMF文件“3.2.S.3.2原料药物特性确认”中,对残留溶媒的研究是一个重要内容。山东鲁抗医药拳头产品大观霉素、泰乐菌素系列产品都通过了FDA认证。笔者结合FDA认证注册较丰富的经验和ICH Q3C(R5)对残留溶剂的指导原则,总结了原料药FDA注册中残留溶剂研究的基本原则。 FDA to implement FDA certification, and require the drug to enter the US market, you must register the file. In the DMF document “3.2.S.3.2 Confirmation of drug properties of raw materials”, the study of residual solvents is an important part. Shandong Lu anti-pharmaceutical products spectinomycin, tylosin products have passed the FDA certification. The author combines the FDA certification registration of rich experience and ICH Q3C (R5) on the residual solvent guidelines, summed up the raw drug FDA registration of residual solvents in the basic principles.