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.
NOTEThroughout 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%.
Loss on drying 731
Dry it in vacuum at 65
for 3 hours: it loses not more than 0.5% of its weight.
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.
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 C
21H
26ClN
3OS.
Auxiliary Information
Staff Liaison :
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29NF24 Page 1689
Pharmacopeial Forum : Volume No. 29(6) Page 1963
Phone Number : 1-301-816-8330