Triflupromazine Hydrochloride
C18H19F3N2S·HCl
388.88
10H-Phenothiazine-10-propanamine,N,N-dimethyl-2-(trifluoromethyl)-,monohydrochloride.
10-[3-(Dimethylamino)propyl]-2-(trifluoromethyl)phenothiazine monohydrochloride [1098-60-8].
»Triflupromazine Hydrochloride contains not less than 97.0percent and not more than 103.0percent of C18H19F3N2S·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant glass 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 by using low-actinic glassware.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
0.5Nsulfuric acid.
Absorptivities at 255nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Prepare a solution of Triflupromazine Hydrochloride in methanol containing 10mg per mL.Apply 10µLeach of this solution and a Standard solution of USP Triflupromazine Hydrochloride RSin methanol containing 10mg per mLto a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of n-propyl alcohol,water,and ammonium hydroxide (88:11:1)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Locate the spots on the plate by spraying lightly with dilute methanolic sulfuric acid (4in 10)and then heating for 15minutes:the RFvalue and color (pink-orange)of the principal spot obtained from the test solution correspond to that obtained from the Standard solution.
Loss on drying á731ñ—
Dry it at 100
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
acetone.
Standard solution:
acetone.
Eluant:
a mixture of chloroform and methanol (4:1).
Visualization:
1.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 800mg of Triflupromazine Hydrochloride,accurately weighed,in 100mLof glacial acetic acid.Add 10mLof mercuric acetate TSand 1drop of 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 38.89mg of C18H19F3N2S·HCl.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1978
Pharmacopeial Forum:Volume No.29(6)Page 1994
Phone Number:1-301-816-8165