Finasteride API content greater than 99%, white powder, USP pharmacopoeia production, 1 kg aluminum tin drum packaging

ndications Finasteride (Proscar) is a 5-reductase inhibitor that blocks the conversion of testosterone to DHT in target tissues. Since DHT is the major intracellular androgen in the prostate, finasteride is effective in suppressing DHT stimulation of prostatic growth and secretory function without markedly affecting libido. It is approved for the treatment of benign prostatic hyperplasia. Although there is usually some regression in the size of the prostate gland following administration of finasteride, clinical response may take 6 to 12 months. If the obstructive symptoms are severe, there is often not enough time to allow this compound to work.The principal adverse effects of finasteride are impotence, decreased libido, and decreased volume of ejaculate. The compound is generally well tolerated in men.

Pharmacopoeia standard

Source (name), content (titer)

This product is n-tert-butyl 3-oxy-4-azaza-5 amino-androsterine-1-ene-17 carboxylamide. According to the dry product calculation, C23H36N2O2 should contain 98.0% ~ 102.0%.

character

This product is white or white like crystalline powder; No smell, bitter taste.

It is soluble in methanol and ethanol, slightly soluble in acetonitrile and ethyl acetate, and almost insoluble in water. It dissolves easily in glacial acetic acid.

Than the curl

Take this product is about 0.5 g, precision said, in the 50 ml volumetric flask and methanol to dissolve and diluted to scale, shake well, in accordance with the determination of 2 (2010 edition pharmacopoeia appendix Ⅵ E), than the curl is + 12 ° to + 14 °.

To identify

(1) take about 20mg of this product, add 0.1g of sodium hydroxide, put it into a test tube, mix it well, and heat it to melt. The gas produced can make the wet red litmus paper turn blue.

(2) in the chromatogram recorded under the content determination, the retention time of the main peak of the sample solution should be consistent with that of the control sample solution.

(3) the infrared absorption spectra of the product shall be consistent with that of the control (figure 793 of the infrared spectra collection of drugs) (if not, the control of the product and finasteride shall be taken, dissolved in methanol and then dried, and the residue shall be determined according to law, and the infrared absorption spectra of the product shall be consistent).