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Perphenazine
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C21H26ClN3OS 403.97

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 98.0 percent and not more than 102.0 percent of C21H26ClN3OS, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Clarity and color of solution— Dissolve 500 mg in 25 mL of 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—
Solution: 10 µg per mL.
Medium: methanol.
Absorptivities at 257 nm, calculated on the dried basis, do not differ by more than 2.5%.
Melting range, Class I 741: between 94 and 100.
Loss on drying 731 Dry it in vacuum at 65 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Ordinary impurities 466
Test solution: a mixture of acetone and methanol (3:1).
Standard solution: solutions of USP Perphenazine Sulfoxide RS in a mixture of acetone and methanol (3:1) except that the solution having a concentration of 0.01 mg per mL is replaced with a solution having a concentration of 0.02 mg per mL.
Eluant: a mixture of acetone and ammonium hydroxide (95:5).
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 400 mg of Perphenazine, previously dried and accurately weighed, in 50 mL of glacial acetic acid, warming slightly to effect solution. Cool to room temperature, add 10 mL of acetic anhydride, and allow to stand for 5 minutes. Add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 20.20 mg of C21H26ClN3OS.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1689
Pharmacopeial Forum : Volume No. 29(6) Page 1963
Phone Number : 1-301-816-8330