Methyltestosterone 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

Methyltestosterone Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of methyltestosterone (C₂₀H₃₀O₂).

2 IDENTIFICATION

A. Infrared Absorption

Sample: Evaporate to dryness 25 mL of the Sample stock solution from the Assay.

Acceptance criteria: The IR absorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima at the same

wavelengths as those of a similar preparation of USP Methyltestosterone RS.

3 ASSAY

Procedure

Standard solution: 10 µg/mL of USP Methyltestosterone RS in alcohol

Sample stock solution: Nominally 0.2 mg/mL of methyltestosterone prepared as follows. Transfer the equivalent to 10 mg of

methyltestosterone from NLT 20 powdered Tablets to a 125-mL separator with the aid of about 5 mL of water. Extract with four 25-mL

portions of chloroform, filtering each through chloroform-washed cotton. Evaporate the combined extracts on a steam bath, with the aid of

a current of air, to dryness. Dissolve the residue in alcohol, transfer to a 50-mL volumetric flask, and dilute with alcohol to volume.

Sample solution: Nominally 10 µg/mL of methyltestosterone in alcohol from the Sample stock solution

Instrumental conditions

Mode: UV

Analytical wavelength: Maximum absorbance at about 241 nm

Cell: 1 cm

Blank: Alcohol

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of methyltestosterone (C₂₀H₃₀O₂) in the portion of Tablets taken:

Result = (Aᵤ / Aₛ) × (Cₛ / Cᵤ) × 100

Aᵤ = absorbance of the Sample solution

Aₛ = absorbance of the Standard solution

Cₛ = concentration of USP Methyltestosterone RS in the Standard solution (µg/mL)

Cᵤ = nominal concentration of methyltestosterone in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Disintegration 〈701〉

Time: 30 min

Acceptance criteria: Tablets intended for buccal administration meet the requirements for Buccal Tablets.

Change to read:

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

Procedure for content uniformity

Standard solution: 0.010 mg/mL of USP Methyltestosterone RS in methanol

Sample stock solution: Transfer 1 finely powdered Tablet to a 100-mL volumetric flask. Add 50 mL of methanol, and shake by mechanical

means for 60 min. Dilute with methanol to volume, and filter, discarding the first 20 mL of the filtrate.

Sample solution: Dilute a suitable volume of the Sample stock solution with methanol to obtain 0.010 mg/mL of methyltestosterone.

Instrumental conditions

Mode: UV

Analytical wavelength: Maximum absorbance at about 241 nm

Cell: 1 cm

Blank: Methanol

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of methyltestosterone (C₂₀H₃₀O₂) in the Tablet taken:

Result = (Aᵤ / Aₛ) × (Cₛ / L) × V × D × 100

Aᵤ = absorbance of methyltestosterone from the Sample solution

Aₛ = absorbance of methyltestosterone from the Standard solution

Cₛ = concentration of USP Methyltestosterone RS in the Standard solution (mg/mL)

L = label claim (mg/Tablet)

V = volume of the Sample solution (mL)

D = dilution factor of the Sample solution

(CN 1-Aug-2023)

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Methyltestosterone RS