Dydrogesterone Tablets
Action and use
Progestogen.
Definition
Dydrogesterone Tablets contain Dydrogesterone.
Content of dydrogesterone, C21H28O2
92.5 to 107.5% of the stated amount.
Identification
Extract a quantity of the powdered tablets containing 60 mg of Dydrogesterone with 20 mL of methanol, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of dydrogesterone (RS 118).
Tests
Related substances
Carry out the method for gas chromatography, Appendix III B.
The test is not valid unless, in the chromatogram obtained with solution (1), the resolution between the peaks due to dydrogesterone and 1,2,3,4-tetraphenylcyclopenta-1,3-diene is at least 1.5.
In the chromatogram obtained with solution (3), the ratio of the sum of the areas of any secondary peaks to the area of the peak due to the internal standard is not greater than the ratio of the area of the peak due to dydrogesterone to the area of the peak due to the internal standard in the chromatogram obtained with solution (1) (2%).
Disregard any secondary peak with an area less than the area of the peak due to dydrogesterone in the chromatogram obtained with solution (4) (0.2%).
Assay
Weigh and powder 20 tablets. Shake a quantity of the powder containing 10 mg of Dydrogesterone for 15 minutes with 70 mL of methanol, dilute to 200 mL with methanol and filter. Dilute 5 mL of the filtrate to 100 mL with methanol and measure the absorbance of the resulting solution at the maximum at 286 nm, Appendix II B. Calculate the content of C21H28O2 taking 845 as the value of A (1%, 1 cm) at the maximum at 286 nm.
Storage
Dydrogesterone Tablets should be protected from light.