Cleaning validation procedure eased by using overpressured layer chromatography.
Cleaning validation procedure eased by using overpressured layer chromatography.
复制标题
通过使用超压层析简化了清洁验证程序。
DOI：
10.1016/s0731-7085(99)00293-9
复制
发表时间：
2000
影响因子：
3.4
通讯作者：
K. Ferenczi
中科院分区：
文献类型：
--
作者：
Z. Katona;L. Vincze;Z. Végh;A. Trompler;K. Ferenczi
在许多制药公司的制造工厂中，反应设备适合生产不同的活性药物成分。完成化合物的生产后，应清洁设备，以避免下一批其他产品的交叉污染。在作者的实验室中，引入了几种色谱方法来测量清洁程序后残留在设备表面的残留物质的量。开发并验证了一种灵敏且相当快速的超压层色谱 (OPLC) 程序，适用于分离和控制同一设备在不同时间生产的五种类固醇激素化合物（烯丙雌醇、雌二醇、乙炔二醇二乙酸酯、左炔诺孕酮、炔诺酮）。
In the manufacturing plants of many pharmaceutical companies the reaction apparatus is suitable to produce different active pharmaceutical ingredients. After completing the production of a compound the equipment should be cleaned in order to avoid the cross contamination in the next lot of the other products. In the authors’ laboratory several chromatographic methods were introduced to measure the amount of the residual substances remaining on the surface of the apparatus after the cleaning procedure. A sensitive and fairly rapid overpressured layer chromatographic (OPLC) procedure — suitable to separate and control five steroid hormone compounds (allylestrenol, estradiol, ethynodiol diacetate, levonorgestel, norethisterone) produced in the same equipment at different times — was developed and validated.