Cleaning level acceptance criteria and a high pressure liquid chromatography procedure for the assay of Meclizine Hydrochloride residue in swabs collected from pharmaceutical manufacturing equipment surfaces.
A method using pharmacologically based and visual limit of detection criteria to determine the acceptable residue level for Meclizine Hydrochloride (MH) on pharmaceutical manufacturing equipment surfaces after cleaning is described. A formula was used in order to determine the pharmacologically safe cleaning level for MH. This level was termed as specific residual cleaning Level (SRCL) and calculated to be 50 microg 100 cm(-2). The visual limit of detection (VLOD) was determined by spiking different levels of MH on stainless steel plates and having the plates examined by a group of observers. The lowest level that could be visually detected by the majority of the observers, 62.5 microg 100 cm(-2), was considered as the VLOD for MH. The lower of the SRCL and VLOD values, i.e. 50 microg 100 cm(-2), was therefore chosen as the cleaning acceptance criterion. A sensitive reversed-phase HPLC method was developed and validated for the assay of MH in swabs used to test equipment surfaces. Using this method, the mean recoveries of MH from spiked swabs and '180-Grit' stainless steel plates were 87.0 and 89.5% with relative standard deviations (RSD) of +/- 3.3 and +/- 2.4%, respectively. The method was successfully applied to the assay of actual swab samples collected from the equipment surfaces. The stability of MH on stainless steel plates, on cleaning swabs and in the extraction solution was investigated.
Mirza
T
T
United States Pharmacopeial Convention, Rockville, MD 20852, USA. tm@usp.org
Lunn
M J
MJ
Keeley
F J
FJ
George
R C
RC
Bodenmiller
J R
JR
D000932:Antiemetics / Q000032:analysis*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004345:Drug Industry / Q000295:instrumentation*; D004350:Drug Residues / Q000032:analysis*; D008468:Meclizine / Q000032:analysis*; D015203:Reproducibility of Results; D012997:Solvents; D013193:Stainless Steel
D000932:Antiemetics; D012997:Solvents; D013193:Stainless Steel; D008468:Meclizine