Packaging and storage—
Preserve in tight, light-resistant containers.
Identification—
A:
Place about 50 mg of Fluphenazine Enanthate and about 50 mg of
USP Fluphenazine Enanthate Dihydrochloride RS in separate, glass-stoppered, small centrifuge tubes, and treat each tube as follows. Add 1.5 mL of sodium hydroxide solution (1 in 250), and mix. Add 2 mL of carbon disulfide, shake vigorously for 2 minutes, and centrifuge. Dry the lower, clear layer by filtering it through 2 g of anhydrous sodium sulfate: the IR absorption spectrum of the test preparation, determined in a 0.1-mm cell, exhibits maxima only at the same wavelengths as that of the Standard preparation, similarly measured.
B:
Ultraviolet Absorption 
197U
—
Solution:
10 µg per mL.
Medium:
methanolic hydrochloric acid (8.5 in 1000).
Absorptivities at 258 nm, calculated on the dried basis, do not differ by more than 2.5%.
Loss on drying 731—
Dry it in vacuum at 60
for 3 hours: it loses not more than 1.0% of its weight.
Heavy metals, Method II 231:
0.003%.
Ordinary impurities 466—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of alcohol, glacial acetic acid, and water (3:1:1).
Visualization:
1.
Assay—
Dissolve about 500 mg of Fluphenazine Enanthate, accurately weighed, in 50 mL of glacial acetic acid, add 1 drop of
crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 27.49 mg of C
29H
38F
3N
3O
2S.
Auxiliary Information—
Staff Liaison :
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 948
Pharmacopeial Forum : Volume No. 29(6) Page 1887
Phone Number : 1-301-816-8330
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