Medroxyprogesterone Acetate Injectable Suspension
» Medroxyprogesterone Acetate Injectable Suspension is a sterile suspension of Medroxyprogesterone Acetate in a suitable aqueous medium. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of medroxyprogesterone acetate (C24H34O4).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
Identification Transfer a volume of Injectable Suspension, equivalent to about 50 mg of medroxyprogesterone acetate, to a centrifuge tube, centrifuge, decant the supernatant, and wash the solids with two 15-mL portions of water, discarding the water washings. Dissolve the solids in 10 mL of chloroform, transfer to a small beaker, evaporate the chloroform on a steam bath, and dry at 105 for 3 hours: the residue so obtained responds to Identification test A under Medroxyprogesterone Acetate.
pH 791: between 3.0 and 7.0.
Other requirements It meets the requirements under Injections 1.
Mobile phase Mix 700 mL of butyl chloride, 300 mL of hexane, both previously saturated with water, and 80 mL of acetonitrile. The acetonitrile concentration may be varied to meet system suitability requirements and to provide elution times of about 12 and 15 minutes for progesterone and medroxyprogesterone acetate, respectively. Pass the solution through a membrane filter (1 µm or finer porosity).
Internal standard solution Prepare a solution of progesterone in Mobile phase containing 0.25 mg per mL.
Standard preparation Dissolve about 8 mg of USP Medroxyprogesterone Acetate RS, accurately weighed, in 20.0 mL of Internal standard solution.
Assay preparation Transfer to a suitable container an accurately measured volume of Injectable Suspension, equivalent to about 50 mg of medroxyprogesterone acetate. Pipet 25 mL of chloroform into the container, shake for about 20 minutes, and centrifuge. Pipet 4 mL of the chloroform layer into a suitable container, and evaporate to dryness. Pipet 20 mL of Internal standard solution into the container to dissolve the residue.
Chromatographic system The liquid chromatograph is equipped with a 254-nm detector and a 2-mm × 25-cm column that contains 5-µm packing L3. The Mobile phase is maintained at a flow rate capable of giving the required resolution and suitable elution times. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution of progesterone and medroxyprogesterone is not less than 5.0, and the relative standard deviation of the peak responses for replicate injections is not more than 2.0%.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of medroxyprogeterone acetate (C24H34O4) in each mL of the Injectable Suspension taken by the formula:
125(C / V)(RU / RS)in which C is the concentration, in mg, of USP Medroxyprogesterone Acetate RS in the Standard preparation; V is the volume, in mL, of Injectable Suspension taken; and RU and RS are the ratios of peak areas of medroxyprogesterone acetate peak to internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3781