Perphenazine
;)
1-Piperazineethanol,4-[3-(2-chloro-10H-phenothiazin-10-yl)propyl-].
4-[3-(2-Chlorophenothiazin-10-yl)propyl]-1-piperazineethanol [58-39-9].
»Perphenazine contains not less than 98.0percent and not more than 102.0percent of C21H26ClN3OS,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Clarity and color of solution—
Dissolve 500mg in 25mLof methanol:the solution is clear and not more than light yellow.
NOTE—Throughout the following procedures,protect test or assay specimens,the USP Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
Identification—
A:
Infrared Absorption á197Mñ.
Solution:
10µg per mL.
Medium:
methanol.
Absorptivities at 257nm,calculated on the dried basis,do not differ by more than 2.5%.
Loss on drying á731ñ—
Dry it in vacuum at 65
for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
a mixture of acetone and methanol (3:1).
Standard solution:
solutions of USP Perphenazine Sulfoxide RSin a mixture of acetone and methanol (3:1)except that the solution having a concentration of 0.01mg per mLis replaced with a solution having a concentration of 0.02mg per mL.
Eluant:
a mixture of acetone and ammonium hydroxide (95:5).
Visualization:
1.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 400mg of Perphenazine,previously dried and accurately weighed,in 50mLof glacial acetic acid,warming slightly to effect solution.Cool to room temperature,add 10mLof acetic anhydride,and allow to stand for 5minutes.Add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 20.20mg of C21H26ClN3OS.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1520
Pharmacopeial Forum:Volume No.29(6)Page 1963
Phone Number:1-301-816-8165