USPUSP-NF
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Fenfluramine Hydrochloride
C12H16F3N·HCl 267.72
 Benzeneethanamine, N-ethyl-α-methyl-3-(trifluoromethyl)-, hydrochloride;
 N-Ethyl-1-[3-(trifluoromethyl)phenyl]propan-2-amine hydrochloride [404-82-0]

BRIEFING

 Fenfluramine Hydrochloride. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.

  1. The proposed liquid chromatographic procedures in the Assay and the test for Organic Impurities were validated using the XSelect CSH C18 brand of column with L1 packing. The typical retention time for fenfluramine is about 8.5 min.

 Description and Solubility information: A white to greyish powder. Sparingly soluble in water and in ethanol.

 (SM4: R. Nguyen)

 Case ID—SUB-1292

USP REFERENCE STANDARDS FOR PURCHASE

USP 4-Fenfluramine Hydrochloride RS
USP Fenfluramine Hydrochloride RS
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