IMS distinguishes ions of a given compound on the basis of their velocities through a drift tube under the influence of a weak electric field. Ion velocity (v) is proportional to the applied electric field (E)
Advantages of IMS
Typical IMS method validation parameters to be considered include selectivity, linearity, reproducibility, recovery and solution stability. Selectivity of the analyte is determined based on evaluation of the molecular structure dictating the mode of detection. Selectivity from the sample matrix is based on minimizing the interference from product excipients and cleaning detergents, and should be examined before performing the recovery experiment. In addition, the linearity is based on a second-order polynomial curve obtained from the response versus the amount introduced, as described previously. Reproducibility must be used to determine the action level. Therefore, these parameters must be considered during method development and verified during validation.
The ease of use and the small footprint of ion mobility spectrometry instrument allows for the system to be implemented in various work environments, such as quality control, and to report results with great sensitivity (nanogram to picogram range). Moreover, data reduction software package upgrade ensures 21 CFR Part 11 compliance. The use of this software, in addition to a limit test, has simplified the process of data manipulation, resulting in high-confidence passes for each clean sample analyzed.
Elizabeth Galella* is a research scientist, Scott Jennings is a senior research scientist, Madhavi Srikoti is an associate research scientist, Elizabeth Bonasso is a research scientist, all at the analytical research and development unit of the Pharmaceutical Research Institute, Bristol-Myers Squibb, One Squibb Drive, New Brunswick, NJ 08903, email@example.com
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3. D. Brand, X. Li, and T. Wortley, "Ion Trap Mobility Spectrometry: Reducing Downtime in Cleaning Validation and Verification," GE Sensing, http://www.gesensing.com/toolsupport/whitepaper.htm accessed June 16, 2009.
4. D. Brand et al., "Direct Swabbing and Surface Recovery with Ion Trap Mobility Spectrometry," GE Sensing, http://www.gesensing.com/products/resources/datasheets/GEsensing_whitepaperfinal.pdf accessed June 2, 2009.
5. R. DeBono, "Ion Mobility Spectrometry: A Fast, Sensitive, and Robust HPLC Alternative," Appl. in Chrom. March, 20–23 (2002), http://trace.smithsdetection.com/Documents/LifeSciences/LE203sBarringer.pdf.
6. G.A. Eiceman, "Advances in Ion Mobility Spectrometry," Crit. Rev. Anal. Chem.22 (1, 2), 471–490 (1990).