Cleaning validation procedure eased by using overpressured layer chromatography

Forced-Flow Development in Overpressured Layer Chromatography

“…This solution is proposed if the resolution is acceptable for shorter development distances [23] e.g., for cleaningvalidation in a steroid manufacturing plant using a single isocratic development [44]. To increase the development distance, multiple development can be used with the same or different development distances and mobile phase compositions.…”

Recent Advances in the Analysis of Steroid Hormones and Related Drugs

“…Examples for the application of OPLC to steroid hormone drugs are the purity test of norgestrel and levonorgestrel (visualization by fluorescence quenching at 254 nm, phosphomolybdic acid or sulfuric acid), 77 allylestrenol drug substance and tablet (sulfuric acid), 78 nandrolone (sulfuric acid; comparison of the impurity profile with those obtained by TLC, HPLC and GC), 79 norethisterone drug substance and tablet (sulfuric acid). 80 OPLC was successfully used in in-process-monitoring 81 and cleaning validation of equipment 82 in the course of the production of bulk steroids and steroid formulations.…”

Cleaning validation 2: Development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent

“…The Food and Drug Administration (FDA) enforces those cleaning processes and the agency published a guide where they specified that no detergent should remain after the cleaning process [3]. It is common to find reports on cleaning validation of drug residues [4][5][6][7][8]. However, reports on cleaning validation of detergents used for the cleaning process are limited [9,10].…”