Cleaning validation procedure eased by using overpressured layer chromatography.
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.
Katona
Z
Z
Gedeon Richter Ltd., Budapest, Hungary. z.katona@richter.hu
Vincze
L
L
Végh
Z
Z
Trompler
A
A
Ferenczi-Fodor
K
K
D002853:Chromatography, Liquid / Q000379:methods*; D004345:Drug Industry / Q000592:standards; D012739:Gonadal Steroid Hormones / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D012739:Gonadal Steroid Hormones