50-41-9

50-41-9 - Names and Identifiers

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+

50-41-9 - Physico-chemical Properties

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

50-41-9 - Risk and Safety

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.)

50-41-9 - Standard

Authoritative Data Verified Data

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.

Last Update：2024-01-02 23:10:35

50-41-9 - Trait

Authoritative Data Verified Data

This product is white or off-white powder; Odorless.
This product is slightly soluble in ethanol, slightly soluble in water or three gas methane, insoluble in ether.

Last Update：2022-01-01 13:39:38

50-41-9 - Differential diagnosis

Authoritative Data Verified Data

take an appropriate amount of this product, precision weighing, add 0.1 mol/L hydrochloric acid solution is dissolved and diluted quantitatively to prepare a solution containing about 25ug per 1 ml, which is determined by UV-Vis spectrophotometry (General rule 0401), there is maximum absorption at wavelengths of 233nm and 290nm, and the absorbance is 0.76 to 0.82 and 0.42 to 0.46, respectively.
The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 268).
This product shows the identification reaction of citrate (General rule 0301).

Last Update：2022-01-01 13:39:39

50-41-9 - Exam

Authoritative Data Verified Data

clarity and color of methanol solution

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.

cis-isomer

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%.

moisture

take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 1.0%.

Heavy metals

take this product 1.0g, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.

Last Update：2022-01-01 13:39:40

50-41-9 - Content determination

Authoritative Data Verified Data

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.

Last Update：2022-01-01 13:39:40

50-41-9 - Category

Authoritative Data Verified Data

drugs for ovulation induction.

Last Update：2022-01-01 13:39:41

50-41-9 - Storage

Authoritative Data Verified Data

light shielding, sealed storage.

Last Update：2022-01-01 13:39:41

50-41-9 - Clomifene Citrate Tablets

Authoritative Data Verified Data

This product contains clomiphene citrate (C26H28ClNO • C6H807) should be 90.0% to 110.0% of the label.

trait

This product is white tablet.

identification

the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), which showed maximum absorption at wavelengths of 233nm and 290nm.
This product shows the identification reaction of citrate (General rule 0301).

examination

dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931, Method 1), with hydrochloric acid solution (9-100) as the dissolution medium, and the rotation speed was rpm, operate in accordance with the law, after 45 minutes, take the appropriate amount of solution, filter, Take 5ml of the filtrate, put it in a 10ml measuring flask, dilute it to the scale with dissolution medium, shake well, the dissolution amount of each tablet was calculated as measured by the method under the content measurement item. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

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.

specification

50mg

storage

light shielding, sealed storage.

Last Update：2022-01-01 13:39:42

50-41-9 - Clomifene Citrate Capsules

Authoritative Data Verified Data

This product contains clomiphene citrate (C26H28ClNO • C6H807) should be 90.0% to 110.0% of the label.

identification

the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), which showed maximum absorption at wavelengths of 233nm and 290nm.
the content of this product shows the identification reaction of citrate (General rule 0301).

examination

dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931, Method 1), with hydrochloric acid solution (9-100) as the dissolution medium, and the rotation speed was rpm, operate according to law, after 45 minutes, take 20ml of the solution, filter, discard 10ml of the initial filtrate, take 5ml of the filtrate accurately, put it in a 10ml measuring flask, dilute it to the scale with dissolution medium, shake it well, the dissolution amount of each pellet was calculated as measured by the method under the content measurement item. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
others should comply with the relevant provisions under the capsule (General 0103).

Content determination

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.