化学原料药中元素杂质含量的风险评估

Risk Assessment of Elemental Impurities Content in Chemical API

考虑到药品的安全性、有效性和质量可控性,化学原料药中元素杂质的研究越来越受到制剂企业的关注,因为原料药中的元素杂质不仅对药品的稳定性产生不利影响,甚至会给患者的身体健康带来潜在危险,所以它们在原料药中的含量需要被控制在可接受的限度范围内。就原料药生产实际,结合元素杂质的来源、分类情况,从风险评估的角度探讨元素杂质含量的限度设定,为企业制定合理的元素杂质控制种类及含量限度提供参考,从而保证化学原料药的质量,进一步保证了最终患者使用的药品质量。

Considering the safety,efficacy and quality controllability of drug products,the study of elemental impurities in chemical active pharmaceutical ingredients (API) is received more and more attention coming from drug product companies,because of the elemental impurities in the API are not only harmful to the stability of the drug product,even a potential danger to the patient’s health,so the contents of them in API need to be controlled in the range of acceptable limits.Now regarding the actual production of API,combining with the sources and classification of elemental impurities,the limits of elemental impurities are discussed from the perspective of risk assessment,so as to offer reference for companies to set reasonable elemental impurities types and content limits,thus effectively guarantee the quality of chemical API,further guarantee the quality of drug product which patients use in the end.