C19H20FNO3·HCl·½H2O 374.83
Piperidine, 3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-, hydrochloride, (3S-trans)-;
(−)-(3S,4R)-4-(p-Fluorophenyl)-3-[[(3,4-methylenedioxy)phenoxy]methyl]piperidine hydrochloride;
(3S,4R)-3-[(Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride
Anhydrous
[78246-49-8] Hemihydrate [110429-35-1]
BRIEFING
Paroxetine Hydrochloride. This proposal is based on the version of the monograph official as of Nov. 1, 2021. It is proposed to revise the monograph as follows:
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Revise Identification C to replace the retention time agreement in the Assay with retention time agreement in the Limit of Paroxetine Related Compound C procedure, to support an evaluation of the stereo-specific identity of paroxetine in the sample.
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Make the following revisions to the Limit of Paroxetine Related Compound C procedure:
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Add the Diluted sample solution to support the proposed change in Identification C.
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Revise the concentration of the Standard solution to align with the acceptance criteria of paroxetine related compound C.
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Add the Sensitivity solution and the Signal-to-noise criterion to strengthen the analysis.
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Replace the column particle size to improve the chromatographic efficiency based on supporting validation data.
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Revise the Tailing factor criterion and use the Standard solution for the requirement based on supporting data.
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Revise Solution A in the Limit of Paroxetine Related Compound E procedure to improve the chromatographic separation of paroxetine related compound E with other potential impurities.
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Replace Organic Impurities, Procedure 1 and Organic Impurities, Procedure 2 with the proposed Organic Impurities procedure that can monitor all the related compounds and impurities. The proposed liquid chromatography procedure in the Organic Impurities procedure was validated using the Zorbax SB brand of column with L7 packing. The typical retention time for paroxetine is about 10 min.
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Revise the Labeling section to reflect the proposed replacement of the Organic Impurities procedure.
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Revise the USP Reference Standards section to delete extraneous note under USP Paroxetine Related Compound E RS and to remove the USP Paroxetine System Suitability Mixture A RS, which is no longer needed with the proposed Organic Impurities procedure.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM4: R. Nguyen)
Correspondence Number—C205413, C311031, C314477