Medroxyprogesterone Acetate Injectable Suspension

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Medroxyprogesterone Acetate Injectable Suspension is a sterile suspension of Medroxyprogesterone Acetate in a suitable aqueous medium. It contains NLT 90.0% and NMT 110.0% of the labeled amount of medroxyprogesterone acetate (C₂₄H₃₄O₄).

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

Sample: Transfer a volume of Injectable Suspension, equivalent to 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 the residue at 105° for 3 h.

Acceptance criteria: Meets the requirements

3 ASSAY

Procedure

Mobile phase: 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 min for Progesterone and medroxyprogesterone acetate, respectively. Pass the solution through a membrane filter of 1 μm or less pore size.

Internal standard solution: 0.25 mg/mL of progesterone in Mobile phase

Standard solution: 0.4 mg/mL of USP Medroxyprogesterone Acetate RS in Internal standard solution

Sample solution: Nominally 0.4 mg/mL of medroxyprogesterone acetate in Internal standard solution, prepared as follows. Transfer a volume of Injectable Suspension, equivalent to 50 mg of medroxyprogesterone acetate, to a suitable container. Transfer 25 mL of chloroform into the container, shake for 20 min, and centrifuge. Transfer 4 mL of the chloroform layer into a suitable container, and evaporate to dryness.

Dissolve the residue in 20 mL of Internal standard solution.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 2-mm × 25-cm; 5-μm packing L3

Flow rate: The Mobile phase is maintained at a flow rate capable of giving the required resolution and suitable elution times.

Injection volume: 10 μL

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT 5.0 between progesterone and medroxyprogesterone acetate

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of medroxyprogesterone acetate (C₂₄H₃₄O₄) in the portion of Injectable Suspension taken:

Result = (R_U/R_S) × (C_S/C_U) × 100

R_U = peak area ratio of medroxyprogesterone acetate to the internal standard from the Sample solution

R_S = peak area ratio of medroxyprogesterone acetate to the internal standard from the Standard solution

C_S = concentration of USP Medroxyprogesterone Acetate RS in the Standard solution (mg/mL)

C_U = nominal concentration of medroxyprogesterone acetate in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

pH 〈791〉: 3.0–7.0

Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass.

USP Reference Standards 〈11〉

USP Medroxyprogesterone Acetate RS