At-line quantitative ion mobility spectrometry for direct analysis of swabs for pharmaceutical manufacturing equipment cleaning verification.
The potential for ion mobility spectrometry (IMS) to provide rapid at-line quantitation of residues on surfaces via direct analysis of swabs is attractive for pharmaceutical manufacturing equipment cleaning verification. In this study, the development of an IMS method to provide acceptable quantitation of active pharmaceutical ingredients and cleaning agents is described. Key modifications to commercially available instrumentation were made to achieve a dynamic range of 5-100 microg per 25 cm2 surface area and acceptable analyte recovery in the presence of ionizable matrix components. The results of this study effectively demonstrate the capability of IMS to serve as an at-line quantitative analytical method.
Strege
Mark A
MA
Lilly Research Laboratories, A Division of Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. strege_mark_a@lilly.com
Kozerski
Jessica
J
Juarbe
Nieves
N
Mahoney
Patrick
P
D003902:Detergents / Q000302:isolation & purification*; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D000068736:Duloxetine Hydrochloride; D013057:Spectrum Analysis / Q000379:methods*; D013501:Surface-Active Agents / Q000302:isolation & purification; D013876:Thiophenes / Q000737:chemistry / Q000302:isolation & purification*
D003902:Detergents; D013501:Surface-Active Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride