» Fluphenazine Decanoate contains not less than 98.0 percent and not more than 102.0 percent of C32H44F3N3O2S, calculated on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
USP Fluphenazine Decanoate Dihydrochloride RS.
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.
A: Place about 50 mg of Fluphenazine Decanoate and about 50 mg of USP Fluphenazine Decanoate 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 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: Use a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Impregnate the plate with a 1 in 20 solution of tetradecane in hexane, and allow to air-dry. Prepare a test solution in alcohol containing 20 mg per mL. Apply 1 µL each of the test solution and of a Standard solution of USP Fluphenazine Decanoate Dihydrochloride RS in alcohol, similarly prepared. Allow the spots to dry. Apply to the spot from the Standard solution, 1.0 µL of 0.1 N sodium hydroxide and allow it to dry. Develop the plate in an equilibrated chamber using a mixture of methanol and water (9:1) as the mobile phase. Examine the plate under short-wavelength UV light at 254 nm: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Loss on drying 731 Dry it in vacuum at 60 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant : a mixture of acetone, cyclohexane, and ammonium hydroxide (16:6:1).
Visualization: 1; then spray the plate with 50% sulfuric acid.
Interpretation: no individual ordinary impurity observed exceeds 1.0% and the total of any ordinary impurities observed does not exceed 2.0%.
Assay Dissolve about 500 mg of Fluphenazine Decanoate, accurately weighed, in 50 mL of glacial acetic acid, add one 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 29.59 mg of C32H44F3N3O2S.
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USP32NF27 Page 2421Pharmacopeial Forum: Volume No. 29(6) Page 1887