注射剂低温循环和冻融稳定性试验的技术要求探讨
Technical Requirements for Low Temperature Cycle and Freeze-thaw Stability Test of Injection
曹新欣 1郭碧莹 1李钰婷 1甘素立1
作者信息
- 1. 广州帝奇医药技术有限公司,广东 广州 510320
- 折叠
摘要
目的:本文介绍了注射剂低温循环和冻融稳定性试验的概念,探讨了注射剂低温循环和冻融稳定性试验的重要意义.方法:通过对比NMPA、ICH和FDA的稳定性指导原则的要求,本文对药物低温循环和冻融稳定性试验进行了归纳总结,综述各个要素的技术要求.结果:通过依达拉奉注射液实例,最终确认了低温循环和冻融稳定性试验的技术要求的具体内容.结论:根据 NMPA、ICH和FDA的稳定性指导原则,以及在现实世界中可能遇到的极端和快速温度变化等各种条件下处理药品的要求,我们设计合理的稳定性方案,以完整、准确和全面考察低温循环和冻融稳定性试验.
Abstract
Objective:The concept of low temperature cycle and freeze-thaw stability test of injection dosage form is introduced in this paper,and the importance of low temperature cycle and freeze-thaw stability test for injections is discussed.Methods:Through comparing the requirements of NMPA,ICH,and FDA guidance,this paper summarizes the low-temperature cycling and freeze-thaw stability testing of drugs and provides an overview of the technical requirements of each element.Results:By using Edaravone injection as an example,the specific content of the technical requirements for low-temperature cycling and freeze-thaw stability testing was confirmed.Conclusion:Based on the stability guidelines of NMPA,ICH,and FDA,and the requirements of handling a pharmaceutical product under various conditions such as extre33me and rapid temperature changes which we may encounter in a real world,we would design a reasonable protocols for a complete,accurate and comprehensive testing of low-temperature cycling and freeze-thaw stability.
关键词
低温循环/冻融/稳定性试验/注射剂/技术要求Key words
low temperature cycle/freeze-thaw/stability test/injection/technical requirements引用本文复制引用
出版年
2024
NETL
NSTL
万方数据