Take about 5mg of this product, put it in a small test tube, add 0.2ml of methanol to dissolve, add about 3mg of sodium nitroferricyanide powder, about 50mg of sodium carbonate and ammonium acetate, shake well, let stand for 10 to 30 minutes, Should be blue and purple. Take about 0.5mg of this product, put it in a small test tube, add about 1mg of isoniazid and 1ml of methanol to dissolve, add 1 drop of dilute hydrochloric acid, which is yellow. The infrared absorption spectrum of this product should be consistent with the control spectrum (spectrum set 434). Chromatographic conditions and system suitability test using octadecylsilane bonded silica as a filler; methanol-water (65:35) as mobile phase; detection wavelength was 254nm.
The number of theoretical plates should be no less than 1000 according to the peak of progesterone, and the resolution of the peak of progesterone and the peak of internal standard should meet the requirements. Preparation of the internal standard solution Take about 25mg of diethylstilbestrol, accurately weighed, placed in a 25ml volumetric flask, dissolved in methanol and diluted to the mark, shake well, that is. Determination method Take about 25mg of this product, accurately weighed, placed in a 25ml volumetric flask, dissolved in methanol and diluted to the mark, shake well; accurately measure the solution and the internal standard solution 5ml each, set in a 25ml volumetric flask, diluted with methanol To the scale, shake well, take 5μl into the liquid chromatograph, record the chromatogram; take the appropriate amount of progesterone reference substance, the same method. According to the internal standard method, the peak area is calculated.