BRIEFING
Pramoxine Hydrochloride Cream. 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 non-specific UV-based Identification A with a chromatographic retention time agreement as obtained in the proposed Assay, to eliminate the use of hazardous solvents.
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Replace the colorimetric test in Identification B with a UV spectrum agreement as obtained in the proposed Assay.
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Replace the Assay procedure with a new HPLC procedure to eliminate the use of an internal standard. The liquid chromatographic procedure is validated using the Eclipse XDB brand of column with L7 packing. The typical retention time for pramoxine is about 11 min.
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Add a storage temperature to the Packaging and Storage section.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM5: S. Ramakrishna)
Case ID—SUB-1068