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Pramoxine Hydrochloride
C17H27NO3·HCl 329.86
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:

  1. Revise Identification A to allow flexibility to use either 197K or 197A.

  2. 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.

  3. Add preparation of Dilute phosphoric acid and update the Buffer preparation in the Assay to be consistent with current USP style.

  4. Add a Run time under Chromatographic system in the Assay to be consistent with the validated procedure.

  5. Revise the system suitability requirement for percent relative standard deviation in the Assay to be consistent with Chromatography 〈621〉.

  6. 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

USP REFERENCE STANDARDS FOR PURCHASE

USP Pramoxine Hydrochloride RS
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