TOREMIFENE CITRATE
TOREMIFENE CITRATE
CAS: 89778-27-8
Molecular Formula: C32H36ClNO8
TOREMIFENE CITRATE - Names and Identifiers
| Name | TOREMIFENE CITRATE |
| Synonyms |
nk622 nk622 fc1157a fareston fc1157a fareston Toremifene citrate TOREMIFENE CITRATE TROPISETRON CITRATE 2-[4-[(1Z)-4-CHLORO-1,2-DIPHENYL-1-BUTENYL]PHENOXY]-N,N-DIMETHYLETHANAMINE (z)-4-chloro-1,2-diphenyl-1-(4-(2-(n,n-dimethylamino)ethoxy)phenyl)-1-butene (z)-4-chloro-1,2-diphenyl-1-(4-(2-(n,n-dimethylamino)ethoxy)phenyl)-1-butene 2-(4-(4-chloro-1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethyl-ethanamin(z)-ethanamin 2-(4-(4-chloro-1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethyl-ethanamin(z)-ethanamin (z)-2-[4-(4-chloro-1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-ethanamine 2-hydroxy-1,2,3-propanetricarboxylate (z)-2-[4-(4-chloro-1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-ethanamine 2-hydroxy-1,2,3-propanetricarboxylate |
| CAS | 89778-27-8 |
| EINECS | 663-344-6 |
| InChI | InChI=1/C26H28ClNO.C6H8O7/c1-28(2)19-20-29-24-15-13-23(14-16-24)26(22-11-7-4-8-12-22)25(17-18-27)21-9-5-3-6-10-21;7-3(8)1-6(13,5(11)12)2-4(9)10/h3-16H,17-20H2,1-2H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/b26-25- |
TOREMIFENE CITRATE - Physico-chemical Properties
| Molecular Formula | C32H36ClNO8 |
| Molar Mass | 598.08 |
| Density | 1,045g/cm |
| Melting Point | 160-162°C |
| Boling Point | 146-148C |
| Solubility | DMSO: >10mg/mL |
| Appearance | powder |
| Color | white to off-white |
| Merck | 14,9550 |
| Storage Condition | 2-8°C |
| Refractive Index | 1,416-1,418 |
| Use | Used as an anticancer drug |
TOREMIFENE CITRATE - Risk and Safety
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R41 - Risk of serious damage to eyes R22 - Harmful if swallowed |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S37/39 - Wear suitable gloves and eye/face protection S61 - Avoid release to the environment. Refer to special instructions / safety data sheets. S60 - This material and its container must be disposed of as hazardous waste. S39 - Wear eye / face protection. |
| UN IDs | UN 3077 9 / PGIII |
| WGK Germany | 3 |
| RTECS | KH2156700 |
TOREMIFENE CITRATE - Standard
Authoritative Data Verified Data
This product is 2-[4-[(Z)-4-chloro-1, 2-diphenyl-1-butene] phenoxy] -N,N-dimethylethylamine citrate. Calculated as dried product, containing not less than 98.5% of C28H28C1NO • C6H807
Last Update：2024-01-02 23:10:35
TOREMIFENE CITRATE - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is slightly soluble in methanol or ethanol, very slightly soluble in acetone, almost insoluble in water; Soluble in glacial acetic acid.
melting point
The melting point of this product (General rule 0612) is 159~163°C, melting and decomposition.
absorption coefficient
take this product, precision weighing, and methanol dissolution and quantitative dilution to prepare about 12ug solution per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 237nm, and the absorption coefficient was 335 to 356.
Last Update：2022-01-01 13:38:55
TOREMIFENE CITRATE - Differential diagnosis
Authoritative Data Verified Data
- the solution under the term of absorption coefficient has the maximum absorption at the wavelength of 237mn as determined by ultraviolet-visible spectrophotometry (General 0401), there is minimal absorption at a wavelength of 221nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 795).
- This product shows the identification reaction of citrate (General rule 0301).
Last Update：2022-01-01 13:38:55
TOREMIFENE CITRATE - Exam
Authoritative Data Verified Data
Related substances
take this product, add mobile phase to dissolve and dilute to make 1.0 mg of the solution was used as a test solution; An appropriate amount was taken in a precise amount and diluted with a mobile phase to prepare a solution containing 1 ug per 1 ml as a control solution. According to high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as filler; Methanol-water-triethylamine (930:69:1) was used as mobile phase; The detection wavelength was 240nm. The number of theoretical plates is not less than 1500 based on the toremifene peak. Accurately measure 20 u1 of each of the above two solutions, respectively inject into the liquid chromatograph, record the chromatogram to 2 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
isomer
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing 2.5mg per lml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, the mobile phase was diluted to the scale and used as a control solution. According to the method of high performance liquid chromatography (General 0512), with thirty carbon alkyl silane bonded silica gel as filler; 0.5% triethylamine solution (with phosphoric acid to adjust the pH value to 3.0 )-acetonitrile-tetrahydrofuran (55:40:5) as mobile phase; The detection wavelength was 240nm. An appropriate amount of Toremifene isomer mixture (about 50% of each isomer) was taken, dissolved and diluted with mobile phase to prepare each solution containing 1 mg per 1 ml, and 10u1 was injected into the liquid chromatograph to record the chromatogram. The order of the peaks is the isomer, and the degree of separation between the two peaks should be in accordance with the regulations. The sample solution and the control solution of 10 u1 were respectively injected into the liquid chromatograph, and the chromatograms were recorded. The Peak area of e-isomer in the test solution shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 13:38:56
TOREMIFENE CITRATE - Content determination
Authoritative Data Verified Data
take about 0.45g of this product, precision weighing, add 50ml of glacial acetic acid to dissolve and add 1 drop of crystal violet indicator solution, use high gas acid titration solution (O. 1 mol/L) titration to the solution is blue-green, and the result of the titration is corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 59.81mg of C26H28C1NO. C6H8O7.
Last Update：2022-01-01 13:38:57
TOREMIFENE CITRATE - Category
Authoritative Data Verified Data
antineoplastic agents.
Last Update：2022-01-01 13:38:57
TOREMIFENE CITRATE - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 13:38:57
TOREMIFENE CITRATE - Toremifene Citrate Tablets
Authoritative Data Verified Data
The product shall contain Toremifene toremifene (C28H28ClNO) and shall be 90.0% to 110.0% of the labeled amount.
trait
This product is white or off-white.
identification
- take an appropriate amount of the fine powder of this product, add the mobile phase to make a solution containing 10ug toremifene per lml, filter, take the filtrate as the test solution; Take another Toremifene reference substance, A solution containing 10ug of toremifene per 1 ml was prepared by adding the mobile phase as a control solution. Take the above two kinds of solutions and test according to the chromatographic conditions under the item of related substances. The retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take the test solution under the content determination item and measure it by ultraviolet-visible spectrophotometry (General 0401), which has the maximum absorption at the wavelength of 237nm, there is minimal absorption at a wavelength of 221nm.
- take an appropriate amount of fine powder of this product (about 10 mg of citric acid), add 2ml of water, shake, filter, and the filtrate should show the reaction of (1) identified by citrate (General rule 0301).
examination
- Related substances the appropriate amount of fine powder of this product is taken, and the mobile phase is added to prepare a test solution containing about Toremifene 1.0 mg per 1 ml and a control solution containing about Toremifene 10ug per 1 ml. According to the test method under the related substances item Toremifene, the sum of the peak areas of each impurity shall not be greater than the main peak area of the control solution (1.0%).
- E-isomer: take an appropriate amount of fine powder of this product (about Toremifene 25mg), put it in a 10ml measuring flask, add an appropriate amount of mobile phase, dissolve it by ultrasound, dilute it to the scale with mobile phase, and shake it well, filter, take the filtrate as a test solution; Take the test solution 1ml, put in a 100ml measuring flask, dilute to the scale with mobile phase, as a control solution. The Peak area of the isomer shall not be greater than 0.5 times (0.5%) the area of the main peak of the control solution tested as described under Toremifene F isomer.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with 0.02mol/L hydrochloric acid solution as the dissolution medium, the rotation speed is 100 rpm, operate in accordance with the law, after 30 minutes, take 10ml of solution, filter, take 5ml of filtrate accurately, put it in a 25ml measuring flask, dilute to the mark with 0.02mol/L hydrochloric acid solution, shake, as a test solution; Another Toremifene reference substance, precision weighing, plus a small amount of methanol to dissolve, quantitative dilution with 0.02mol/L hydrochloric acid solution to make a solution containing 8ug of toremifene per 1 ml, as a control solution. The absorbance of each of the above two Solutions was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general), and the elution amount of each tablet was calculated. The limit is 75% 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 (about 20mg equivalent to toremifene), put it in a 100ml measuring flask, add an appropriate amount of methanol, shake, dissolve Toremifene, dilute to the scale with methanol, shake well, filter, take 2ml of continued filtrate precisely, put it in a 50ml measuring flask, dilute to the scale with methanol, shake well, as a test solution, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 237nm; Another Toremifene of the reference substance, the same method for determination, calculation, and the result is multiplied by 0.6790, that is.
category
Same as Toremifene.
specification
40mg (as toremifene)
storage
sealed storage.
Last Update：2022-01-01 13:38:58
