Perphenazine Injection
»Perphenazine Injection is a sterile solution of Perphenazine in Water for Injection,prepared with the aid of Citric Acid.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C21H26ClN3OS,as the citrate.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
USP Reference standards á11ñ— USP Endotoxin RS.USP Perphenazine RS.
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— Dilute 1mLwith methanol to 5mL.Apply 5µLeach of this solution and a solution of USP Perphenazine RSin methanol containing 1mg per mLto 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 15cm.Air-dry the plate,and spray lightly with a solution of iodoplatinic acid prepared by dissolving 100mg of chloroplatinic acid in 1mLof 1Nhydrochloric acid,adding 25mLof potassium iodide solution (4in 100),diluting with water to 100mL,and adding 0.50mLof formic acid:the RFvalue of the principal spot obtained from the Injection corresponds to that obtained from the Standard solution.
Bacterial endotoxins á85ñ— It contains not more than 35.7USP Endotoxin Units per mg of perphenazine.
pHá791ñ: between 4.2and 5.6.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Acid-alcohol solution— Transfer 10mLof hydrochloric acid to a 1000-mLflask containing 500mLof alcohol and 300mLof water.Dilute with water to volume.
Palladium chloride solution— Dissolve 100mg of palladium chloride in a mixture of 1mLof hydrochloric acid and 50mLof water in a 100-mLvolumetric 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 30days.On the day of use,transfer 50mLto a 500-mLvolumetric flask,add 4mLof hydrochloric acid and 4.1g of anhydrous sodium acetate,dilute with water to volume,and mix.
Standard preparation— Dissolve an accurately weighed quantity of USP Perphenazine RSin Acid-alcohol solutionto obtain a solution having a known concentration of about 150µg per mL.
Assay preparation— Dilute 3.0mLof Injection with Acid-alcohol solutionto 100mLin a volumetric flask.
Procedure— Mix 10.0mLeach of the Assay preparationand the Standard preparationwith 15.0mLof 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 480nm,with a suitable spectrophotometer.Calculate the quantity,in mg,of C21H26ClN3OSin the volume of Injection taken by the formula:
0.1C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Perphenazine RSin the Standard preparation,and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1520
Phone Number:1-301-816-8165