Medroxyprogesterone Acetate Tablets

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 Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of medroxyprogesterone acetate (C₂₄H₃₄O₄).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Triturate a number of Tablets, equivalent to about 25 mg of medroxyprogesterone acetate, with 15 mL of chloroform. Filter, evaporate the chloroform on a steam bath, and dry the residue at 105° for 3 h.

Acceptance criteria: Meet the requirements

3 ASSAY

Procedure

Mobile phase: Acetonitrile and water (40:60)

Standard solution: 1 mg/mL of USP Medroxyprogesterone Acetate RS in acetonitrile

Sample solution: Finely powder NLT 20 Tablets. Weigh a portion of the powder, equivalent to 25 mg of medroxyprogesterone acetate, into a 50-mL glass centrifuge tube. Transfer 25 mL of acetonitrile into the tube, shake to wet the powder thoroughly, sonicate for NLT 10 min, and centrifuge. Use the clear supernatant.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm × 30-cm; packing L1

Flow rate: 2 mL/min

Injection volume: 10 μL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2

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 Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response 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: 93.0%–107.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: 0.5% sodium lauryl sulfate; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Mobile phase: Acetonitrile and water (60:40)

Sodium lauryl sulfate stock solution: Transfer 180.0 g of sodium lauryl sulfate to a 2000-mL volumetric flask. Add 1500 mL of water, and stir until dissolved. [Note—Several hours of stirring are required.] Dilute with water to volume.

Standard stock solution: 70 mg of USP Medroxyprogesterone Acetate RS in 140 mL of Sodium lauryl sulfate stock solution. Dilute with water to 250 mL. [Note—It may be necessary to sonicate the solution to bring the Reference Standard into solution before dilution with water.]

Prepare the Standard stock solution fresh daily.

Standard solution: Transfer a 20-mL aliquot of Standard stock solution into a 1-L volumetric flask. Add 40 mL of Sodium lauryl sulfate stock solution, and dilute with water to volume. This solution is stable for up to 7 days.

Sample solution: Withdraw 15 mL of the solution under test and filter, discarding the first 5 mL of the filtrate.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm × 8-cm; packing L7

Flow rate: 1.5 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 1.2

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of medroxyprogesterone acetate (C₂₄H₃₄O₄) dissolved using the responses from the

Sample solution and Standard solution.

Tolerances: NLT 50% (Q) of the labeled amount of medroxyprogesterone acetate (C₂₄H₃₄O₄) is dissolved.

Change to read:

Uniformity of Dosage Units 〈905〉: Meet the requirements (CN 1-Aug-2023)

Procedure for content uniformity

Diluent: Alcohol and water (3:1)

Standard solution: 15 μg/mL of USP Medroxyprogesterone Acetate RS in Diluent

Sample solution: Nominally 15 μg/mL of medroxyprogesterone acetate in Diluent prepared as follows. Transfer 1 Tablet to a volumetric flask, dilute with Diluent to volume, and shake for 15 min. Filter, and quantitatively dilute a portion of the

ltrate as needed.

Instrumental conditions

Mode: UV-Vis

Analytical wavelength: Maximum at about 242 nm

Cell: 1 cm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of medroxyprogesterone acetate (C₂₄H₃₄O₄) in the Tablet taken:

Result = (A_U/A_S) × (C_S/C_U) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

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

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

(CN 1-Aug-2023)

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉