title: Ion mobility spectrometry for the simultaneous determination of diacetyl midecamycin and detergents in cleaning validation.
abstract: In the present paper, we have developed two different approaches based on ion mobility spectrometry (IMS) for the cleaning validation of diacetyl midecamycin in the surfaces of manufacture equipment: a semi-quantitative approach based on the use of a sample wand and a quantitative procedure based on the swab test. The simultaneous determination of the active pharmaceutical ingredient and cleaning agents has been performed without important effects of ionization suppression upon the analysis of swabs containing multiple components. Sensitivity, in the ng range, and appropriate selectivity ratify IMS as a serious alternative, a fast and serious alternative in cleaning validation. Other advantage imply its potential for at-line use to perform a semi-quantitative procedure using a sample wand which allows Teflon membranes, swabbed onto the stainless steel surfaces, to be introduced directly into the instrument with no dilution or extraction.
authors.affiliation: Department of Chemistry, Faculty of Sciences, Universitat Autònoma de Barcelona, E-08193 Bellaterra, Barcelona, Spain. sergio.armenta@uab.cat
authors.forename: S
authors.initials: S
authors.lastname: Armenta
authors.forename: M
authors.initials: M
authors.lastname: Alcalà
authors.forename: M
authors.initials: M
authors.lastname: Blanco
authors.forename: J M
authors.initials: JM
authors.lastname: González
mesh_terms: D003902:Detergents / Q000737:chemistry*; D004345:Drug Industry / Q000379:methods; D004866:Equipment Contamination; D007477:Ions / Q000737:chemistry*; D007933:Leucomycins / Q000737:chemistry*; D013057:Spectrum Analysis / Q000379:methods*; D013193:Stainless Steel / Q000032:analysis
chemical_list: D003902:Detergents; D007477:Ions; D007933:Leucomycins; D013193:Stainless Steel; C026483:midecamycin