» Perphenazine Injection is a sterile solution of Perphenazine in Water for Injection, prepared with the aid of Citric Acid. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C21H26ClN3OS, as the citrate.
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Endotoxin RS.
USP Perphenazine 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.
Identification Dilute 1 mL with methanol to 5 mL. Apply 5 µL each of this solution and a solution of USP Perphenazine RS in methanol containing 1 mg per mL to a suitable thin-layer chromatographic plate, coated with a 0.25-mm layer of chromatographic silica gel. Develop the chromatogram in a solvent system consisting of a mixture of acetone and ammonium hydroxide (200:1) until the solvent front has moved about 15 cm. Air-dry the plate, and spray lightly with a solution of iodoplatinic acid prepared by dissolving 100 mg of chloroplatinic acid in 1 mL of 1 N hydrochloric acid, adding 25 mL of potassium iodide solution (4 in 100), diluting with water to 100 mL, and adding 0.50 mL of formic acid: the RF value of the principal spot obtained from the Injection corresponds to that obtained from the Standard solution.
Bacterial endotoxins 85 It contains not more than 35.7 USP Endotoxin Units per mg of perphenazine.
pH 791: between 4.2 and 5.6.
Other requirements It meets the requirements under Injections 1.
Acid-alcohol solution Transfer 10 mL of hydrochloric acid to a 1000-mL flask containing 500 mL of alcohol and 300 mL of water. Dilute with water to volume.
Palladium chloride solution Dissolve 100 mg of palladium chloride in a mixture of 1 mL of hydrochloric acid and 50 mL of water in a 100-mL volumetric flask, heating on a steam bath to effect solution. Cool, dilute with water to volume, and mix. Store in an amber bottle and use within 30 days. On the day of use, transfer 50 mL to a 500-mL volumetric flask, add 4 mL of hydrochloric acid and 4.1 g of anhydrous sodium acetate, dilute with water to volume, and mix.
Standard preparation Dissolve an accurately weighed quantity of USP Perphenazine RS in Acid-alcohol solution to obtain a solution having a known concentration of about 150 µg per mL.
Assay preparation Dilute 3.0 mL of Injection with Acid-alcohol solution to 100 mL in a volumetric flask.
Procedure Mix 10.0 mL each of the Assay preparation and the Standard preparation with 15.0 mL of Palladium chloride solution, filter, if necessary, and concomitantly determine the absorbances of these solutions, against a reagent blank, in 1-cm cells at the wavelength of maximum absorbance at about 480 nm, with a suitable spectrophotometer. Calculate the quantity, in mg, of C21H26ClN3OS in the volume of Injection taken by the formula:
0.1C(AU / AS)in which C is the concentration, in µg per mL, of USP Perphenazine RS in the Standard preparation, and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3260