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. © 2013 Elsevier B.V.
|Journal||Journal of Pharmaceutical and Biomedical Analysis|
|Publication status||Published - 1 Sep 2013|
- Cleaning agents
- Cleaning validation
- Diacetyl midecamycin
- Ion mobility spectrometry