Perphenazine Tablets
» Perphenazine Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C21H26ClN3OS.
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 11
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— Shake a portion of finely powdered Tablets, equivalent to about 5 mg of perphenazine, with about 10 mL of chloroform, filter, evaporate the filtrate on a steam bath nearly to dryness, and dissolve the residue in 5 mL of methanol: the solution so obtained responds to the Identification test under Perphenazine Injection.
Dissolution 711
Medium: 0.1 N hydrochloric acid; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C21H26ClN3OS dissolved from UV absorbances at the wavelength of maximum absorbance at about 257 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Perphenazine RS in the same medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C21H26ClN3OS is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Acid-alcohol solution and Palladium chloride solution Prepare as directed in the Assay under Perphenazine Injection.
Standard preparation— Prepare as directed in the Assay under Perphenazine Syrup.
Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer a portion of the powder, equivalent to about 4 mg of perphenazine, to a glass-stoppered conical flask, pipet into the flask 25 mL of Acid-alcohol solution, shake by mechanical means for 30 minutes, and centrifuge a portion of the mixture. The clear supernatant fluid is the Assay preparation.
Procedure— Proceed as directed for Procedure in the Assay under Perphenazine Injection. Calculate the quantity, in mg, of C21H26ClN3OS in the portion of Tablets taken by the formula:
0.025C(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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3262