Azaperone Injection
» Azaperone Injection is a sterile solution of Azaperone in Water for Injection, prepared with the aid of Tartaric Acid. It may contain a suitable preservative and a stabilizing agent. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C19H22FN3O.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light.
Labeling— Label it to indicate that it is for veterinary use only.
USP Reference standards 11—
USP Azaperone RS Click to View Structure
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for azaperone, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation, obtained as directed in the Assay.
pH 791: between 4.0 and 5.6.
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase— Prepare a filtered and degassed mixture containing 6 volumes of acetonitrile and 4 volumes of 0.01 M dibasic potassium phosphate, and adjust by the addition of dilute phosphoric acid (1 in 10) to a pH of 7.8 ± 0.1. Make adjustments if necessary (see System Suitability under Chromatography 621).
Internal standard solution— Prepare a solution of benzophenone in methanol containing about 0.5 mg per mL.
Standard preparation— Dissolve an accurately weighed quantity of USP Azaperone RS in methanol, and dilute quantitatively with methanol to obtain a solution having a known concentration of about 0.5 mg per mL. Combine 2.5 mL of this solution with 2.5 mL of Internal standard solution, dilute quantitatively with methanol to 10.0 mL, and mix.
Assay preparation— Dilute an accurately measured volume of Injection quantitatively with methanol to obtain a solution containing about 0.5 mg of azaperone per mL. Combine 2.5 mL of this solution with 2.5 mL of Internal standard solution, dilute quantitatively with methanol to 10.0 mL, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with 243-nm detector and a 4.6-mm × 25-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the azaperone and internal standard peaks is not less than 2.7; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of azaperone (C19H22FN3O) in each mL of the Injection taken by the formula:
(C)(L / D)(RU / RS)
in which C is the concentration, in mg per mL, of USP Azaperone RS in the Standard preparation; L is the labeled quantity, in mg, of azaperone in each mL of the Injection; D is the concentration, in mg per mL, of azaperone in the Assay preparation, based on the volume of Injection taken and the extent of dilution; and RU and RS are the ratios of the azaperone peak to the benzophenone peak obtained 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 Morgan Puderbaugh, B.S.
Associate Scientific Liaison
1-301-998-6833		 (SM32010) Monographs - Small Molecules 3
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 2275