» 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 standards 11
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.
Medium: 0.3% sodium lauryl sulfate; 500 mL.
Apparatus 2: 100 rpm.
Time: 60 minutes.
Procedure Determine the amount of C21H28O2 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 C21H28O2 is dissolved in 60 minutes.
Uniformity of dosage units 905: meet the requirements.
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 C 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.
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USP35NF30 Page 2999