Triflupromazine
;)
10H-Phenothiazine-10-propanamine,N,N-dimethyl-2-(trifluoromethyl)-.
10-3-(Dimethylamino)propyl-2-(trifluoromethyl)phenothiazine [146-54-3].
»Triflupromazine contains not less than 97.0percent and not more than 103.0percent of C18H19F3N2S.
Packaging and storage—
Preserve in tight,light-resistant containers.
USP Reference standards á11ñ—
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.
Identification—
A:
It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ,USP Triflupromazine Hydrochloride RSbeing used,and 0.01Nhydrochloric acid being used in place of water to dissolve the specimen.
Solution:
7µg per mL.
Medium:
0.5Nsulfuric acid.
Absorptivities at 255nm do not differ by more than 3.0%.
Residue on ignition á281ñ:
not more than 0.2%.
Ordinary impurities á466ñ—
Test solution:
acetone.
Standard solution:
acetone.
Eluant:
a mixture of chloroform and methanol (4:1).
Visualization:
1.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 800mg of Triflupromazine,accurately weighed,in 100mLof glacial acetic acid.Add crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 35.24mg of C18H19F3N2S.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1977
Phone Number:1-301-816-8165