BRIEFING
Dextromethorphan Hydrobromide Oral Solution. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:
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Replace the chemical test in Identification B with the retention time agreement of the major peak of the Sample solution and Standard solution, as obtained in the Assay.
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In the Assay:
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Update the Chromatographic system by adding the Run time based on supporting data available, using same chromatographic conditions.
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Revise the Suitability requirements for the Relative standard deviation and Tailing factor to be consistent with the expectation of modern chromatographic systems, based on supporting data.
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Update the calculation equation to align with the Acceptance criteria and the molecular weight of hydrous dextromethorphan based on updated chemical information. Delete "on the anhydrous basis" from the variable definition list for the concentration of the Standard solution, as the Reference Standard label specifies the value to be used for quantitative purposes.
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Add the storage temperature in the Packaging and Storage section based on approved manufacturer's storage conditions.
Manufacturers are encouraged to submit validated procedures for the Assay and Organic Impurities test that may be incorporated in future revisions for replacing the ammonium nitrate reagent used in the Mobile phase.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM2: J. Thomas)
Correspondence Number—C321085