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Cleaning Verification: Method Development and Validation Using Ion Mobility Spectrometry
The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.
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)
in which K is the ion mobility in units of cm2 /Vs. Drift time t is proportional to 1/K , ion mass m, and collisional cross section C.
Reduced mobility Ko for an analyte is calculated by normalizing its drift time to that of the internal calibrant as in the following equation:
in which (KoC) is the reduced mobility of the calibrant and t C is the drift time of the calibrant.
Figure 3: Illustration of ions of varying sizes migrating toward the detector through a constant flow of air.
These velocities, or ion mobilities, are determined and selective for a given compound. The high sensitivity of the instrument
(nanogram to picogram range) provides for an excellent technique to quickly verify equipment cleanliness. Figure 3 illustrates
the separation process described in the theory above. This technique allows for positive or negative mode of detection. Each
mode has a unique internal calibrant used for calculation of the Ko. In the positive mode the internal calibrant is nicotinamide. In the negative mode the internal calibrant is methyl salicylate.
Elizabeth Galella is a research scientist at the analytical research and development unit of the Pharmaceutical Research Institute, Bristol-Myers Squibb, One Squibb Drive, New Brunswick, NJ 08903.
Articles by Elizabeth Galella
Scott Jennings
Scott Jennings is a senior research scientist at the analytical research and development unit of the Pharmaceutical Research Institute, Bristol-Myers Squibb.
Articles by Scott Jennings
Madhavi Srikoti
Madhavi Srikoti is an associate research scientist at the analytical research and development unit of the Pharmaceutical Research Institute, Bristol-Myers Squibb.
Articles by Madhavi Srikoti
Elizabeth Bonasso
Elizabeth Bonasso is a research scientist at the analytical research and development unit of the Pharmaceutical Research Institute, Bristol-Myers Squibb.
Articles by Elizabeth Bonasso
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