Morpholine, 4-[3-(4-butoxyphenoxy)propyl]-, hydrochloride;
4-[3-(p-Butoxyphenoxy)propyl]morpholine hydrochloride [637-58-1]
BRIEFING
Pramoxine Hydrochloride. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to revise the monograph with the following changes:
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Revise Identification A to allow flexibility to use either 197K or 197A.
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Delete the Column efficiency requirement for System suitability in the Assay as the Tailing factor and percent relative standard deviation can adequately establish the suitability of the chromatographic system.
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Add preparation of Dilute phosphoric acid and update the Buffer preparation in the Assay to be consistent with current USP style.
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Add a Run time under Chromatographic system in the Assay to be consistent with the validated procedure.
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Revise the system suitability requirement for percent relative standard deviation in the Assay to be consistent with Chromatography 〈621〉.
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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-1069