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C18H19F3N2S 352.42

10H-Phenothiazine-10-propanamine, N, N-dimethyl-2-(trifluoromethyl)-.
10-3-(Dimethylamino)propyl-2-(trifluoromethyl)phenothiazine [146-54-3].
» Triflupromazine contains not less than 97.0 percent and not more than 103.0 percent of C18H19F3N2S.
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 11 USP Triflupromazine Hydrochloride RS.
NOTE—Throughout the following procedures, protect test or assay specimens, the Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.
A: It meets the requirements under Identification—Organic Nitrogenous Bases 181, USP Triflupromazine Hydrochloride RS being used, and 0.01 N hydrochloric acid being used in place of water to dissolve the specimen.
Solution: 7 µg per mL.
Medium: 0.5 N sulfuric acid.
Absorptivities at 255 nm do not differ by more than 3.0%.
Residue on ignition 281: not more than 0.2%.
Ordinary impurities 466
Test solution: acetone.
Standard solution: acetone.
Eluant: a mixture of chloroform and methanol (4:1).
Visualization: 1.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 800 mg of Triflupromazine, accurately weighed, in 100 mL of glacial acetic acid. Add crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 35.24 mg of C18H19F3N2S.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 2202
Phone Number : 1-301-816-8330