Name | clomifene dihydroen citrate |
Synonyms | Clomifene Citrate clomiphene citrate CLOMEPHENE CITRATE Clomiphene Citrate Testosterone Undecante clomifene dihydroen citrate 2-(4-[2-Chloro-1,2-diphenylethenyl]phenoxy)-N,N-diethylethanamine citrate 2-{4-[(E)-2-chloro-1,2-diphenylethenyl]phenoxy}-N,N-diethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate (salt) 2-{4-[(Z)-2-chloro-1,2-diphenylethenyl]phenoxy}-N,N-diethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate (salt) |
CAS | 50-41-9 43054-45-1 |
EINECS | 200-035-3 |
InChI | InChI=1/C26H28ClNO.C6H8O7/c1-3-28(4-2)19-20-29-24-17-15-22(16-18-24)25(21-11-7-5-8-12-21)26(27)23-13-9-6-10-14-23;7-3(8)1-6(13,5(11)12)2-4(9)10/h5-18H,3-4,19-20H2,1-2H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/b26-25+ |
Molecular Formula | C26H28ClNO.C6H8O7 |
Molar Mass | 598.088 |
Boling Point | 509°C at 760 mmHg |
Flash Point | 261.6°C |
Vapor Presure | 1.77E-10mmHg at 25°C |
Use | Hormone drugs for the treatment of luteal insufficiency, anovulatory infertility, dysfunctional uterine bleeding and other diseases |
Hazard Symbols | T - Toxic |
Risk Codes | R60 - May impair fertility R63 - Possible risk of harm to the unborn child |
Safety Description | S53 - Avoid exposure - obtain special instructions before use. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
This product is a citrate salt of a mixture of N, n-diethyl-2-[4-(1, 2-diphenyl-2-chlorovinyl) phenoxy] ethylamine cis-trans isomers. The content of C26H28C1N0 • C6H807 shall not be less than 98.0% calculated as anhydrous.
take l.Og of this product, add methanol 30ml to dissolve, the solution should be clear and colorless; If the color is colored, compared with the yellow No. 1 Standard Colorimetric solution (General rule 0901 first method), not deeper.
This product is dissolved by adding mobile phase and diluted to prepare a solution containing about 0.1 mg per 1 ml as a test solution. According to the determination by HPLC (General 0512), using silica gel as filler and n-hexane-chloroform-triethylamine (80:20:1) as mobile phase (the amount of triethylamine can be changed appropriately; if necessary, chloroform can be washed with water, dried over anhydrous sodium sulfate, followed by fresh distillation), the detection wavelength is 302nm, the number of theoretical plate is not less than 3000 according to the cis isomer peak, CIS, CIS, the resolution of the trans-isomer peaks should be greater than 1.3. 20ul of the sample solution was injected into the liquid chromatograph, and the chromatogram was recorded. The peak sequence was cis-isomer (Z) and trans-isomer (E). According to the peak area normalization method, the sample containing cis isomer should be 30% ~ 50%.
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 1.0%.
take this product 1.0g, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.
take about 0.5g of this product, precision weighing, add 20ml of glacial acetic acid to dissolve, add 1 drop of crystal violet indicator solution, and use perchloric acid titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Per 1 ml of perchloric acid titration solution (0.1 mol/ L corresponds to 59.81mg of C26H28ClNO. C6H807.
drugs for ovulation induction.
light shielding, sealed storage.
This product contains clomiphene citrate (C26H28ClNO • C6H807) should be 90.0% to 110.0% of the label.
This product is white tablet.
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to clomiphene citrate 50mg ), put it in a 100ml measuring flask, add 0.lmol/L hydrochloric acid solution, shaking for 30 minutes to dissolve clomiphene citrate, with 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, filter, Take 5ml of filtrate accurately, put it in another 100ml measuring flask, use 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, as the test solution, according to UV-visible spectrophotometry (General 0401), at the wavelength of 290nm absorbance; another reference product of gas-miphene citrate, precision weighing, plus 0.lmol/L hydrochloric acid solution is dissolved and quantitatively diluted to make a solution containing about 25ug per lml, which is determined and calculated by the same method.
Same as clomiphene citrate.
50mg
light shielding, sealed storage.
This product contains clomiphene citrate (C26H28ClNO • C6H807) should be 90.0% to 110.0% of the label.
take the contents under the difference of loading, mix evenly, weigh an appropriate amount (about 50mg clomiphene citrate) accurately, put it in a 100ml measuring flask, add 0.lmol/L hydrochloric acid solution, shaking for 30 minutes to dissolve clomiphene citrate, with 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, filter, Take 5ml of filtrate accurately, put it in another 100ml measuring flask, use 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, as the test solution, according to UV-visible spectrophotometry (General 0401), at the wavelength of 290mn absorbance; another clomiphene citrate reference product, precision weighing, plus 0.lmol/L hydrochloric acid solution is dissolved and quantitatively diluted to make a solution containing about 25ug per lml, which is determined and calculated by the same method.
Same as clomiphene citrate.
50mg
light shielding, sealed storage.