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Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
45, Number 6, July 2007, pp.293-297
Development of a Residual Solvent Test for Bulk
α-Phenyl-1-(2-phenylethyl)-piperine Methanol
Using Headspace Sampling
C. B’Hymer
University of Cincinnati, Mail Location 0172, Cincinnati, OH 45221-0172
An automated static headspace gas chromatographic
method for
the determination of residual solvents in the bulk drug substance
α-phenyl-1-(2-phenylethyl)-piperine methanol, a serotonin 5-HT2
receptor antagonist, is evaluated. The method includes the use
of
1-propanol as an internal standard. The gas chromatographic
conditions utilize a dimethylpolysiloxane phase (SPB-1) capillary
column and a flame ionization detector. Validation of this test
method includes a recovery study of known levels of acetone, ethyl
acetate, methanol, and methyl ethyl ketone in the range of 0.05%
to 1.0% (weight-per-weight or w/w) to verify the accuracy of this
method; these four solvents are the most likely residual volatiles
used in the production of the drug substance. These data and other
aspects of the development of this test method are discussed.
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