残留溶剂的方法学验证

Method Validation for Residual Solvents

抗生素类药品的生产过程中会用到各种有机溶剂,最终产品也因此会残留这些溶剂,残留量的多少会直接对产品的质量及人体造成伤害。因此,有机溶剂残留量的检测方法就至关重要。有机溶剂残留量的检测方法在《中国药典》中没有明确的检测方法。我公司同时生产舒巴坦酸、他唑巴坦、托西酸舒他西林、舒他西林、哌拉西林、舒巴坦钠、舒巴坦匹酯等这些产品,产品中残留溶剂检测方法的不一致导致了资源的浪费。为整合检验方法使其共用一个方法检测,特制定了本验证方案,进行了验证试验。

The organic solvents used or formed in the manufacture of API or auxiliary material,and preparation of formulation,but not removed completely,can be hazardous to environment and human. In order to ensure the drug safety and control the product quality,the residue of organic solvents should be studied and controlled. No matter what kind of method is used,the study on the method should be conducted to justify if the method is feasible and reasonable.