Dydrogesterone Tablets
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
» Dydrogesterone Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C21H28O2.
Packaging and storage—-Preserve in well-closed containers.
USP REFERENCE STANDARD (11)-
USP Dudrogesterone RS
Identification—Extract a quantity of the powdered Tablets, containing about 60 mg of Dydrogesterone, with 20 mL of methanol, filter, and evaporate to dryness: the residue so obtained responds to identification test A under Dydrogesterone
DISSOLUTION (711)-
Medium: 0.3% sodium lauryl sulfate; 500 mL.
Apparatus 2: 100 rpm.
Time: 60 minutes.
Procedure-Determine the amount of CHO, dissolved from UV absorbances at the wavelength of maximum absorbance at about 295 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution
having a known concentration of USP. Dydrogesterone RS in the same medium.
Tolerances-Not less than 75% (Q) of the labeled amount of C, H, O, is dissolved in 60 minutes.
UNIFORMITY OF DOSAGE UNITS (905): meet the requirements
Assay—
Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system-Proceed as directed in the Assay under Dydrogesterone
Assay preparation-Weigh and finely powder not less than 20 Tablets. Transfer a portion of the powder, equivalent to about 20 mg of Dydrogesterone, to a 200-ml, volumetric flask, add about 100 ml of Mobile phase, and sonicate for 10 minutes. Cool to room temperature, dilute with Mobile phase to volume, and mix.
Procedure-Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and determine the peak responses by area measurement. Calculate the quantity, in mg, of C21H28O2, in the portion of Tablets taken by the formula:
200C(rU/(rS)
in which is the concentration, in mg per ml, of USP Dydrogesterone RS in the Standard preparation, and rU and rS are the Dydrogesterone peak area responses from the Assay preparation and the Standard preparation, respectively.
