trimebutine maleate
trimebutine maleate
CAS: 34140-59-5
Molecular Formula: C26H33NO9
trimebutine maleate - Names and Identifiers
| Name | trimebutine maleate |
| Synonyms | Modulon Digerent Polibutin Cerekinon trimebutine maleate (Z)-but-2-enedioate 2-(Dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate maleate 2-(dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate maleate 2'-PHENYL-2'-DIMETHYLAMINO-N-BUTYL 3,4,5-TRIMETHOXYBENZOATE MALEATE dimethyl-[1-phenyl-1-[(3,4,5-trimethoxybenzoyl)oxymethyl]propyl]ammonium 3,4,5-trimethoxybenzoic acid 2-(dimethylamino)-2-phenylbutyl ester maleate 3,4,5-trimethoxy-benzoic aci beta-(dimethylamino)-beta-ethylphenethyl ester 3,4,5-TRIMETHOXYBENZOIC ACID 2-(DIMETHYLAMINO)-2-PHENYLBUTYL ESTER MALEATE SALT N,N-dimethyl-2-phenyl-1-{[(3,4,5-trimethoxyphenyl)carbonyl]oxy}butan-2-aminium (2Z)-3-carboxyprop-2-enoate |
| CAS | 34140-59-5 |
| EINECS | 251-845-9 |
| InChI | InChI=1/C22H29NO5.C4H4O4/c1-7-22(23(2)3,17-11-9-8-10-12-17)15-28-21(24)16-13-18(25-4)20(27-6)19(14-16)26-5;5-3(6)1-2-4(7)8/h8-14H,7,15H2,1-6H3;1-2H,(H,5,6)(H,7,8)/p-1/b;2-1- |
| InChIKey | FSRLGULMGJGKGI-BTJKTKAUSA-N |
trimebutine maleate - Physico-chemical Properties
| Molecular Formula | C26H33NO9 |
| Molar Mass | 503.54 |
| Melting Point | 122-124°C |
| Boling Point | 629.9°C at 760 mmHg |
| Flash Point | 334.7°C |
| Solubility | Slightly soluble in water, soluble in acetonitrile, sparingly soluble in acetone, slightly soluble in ethanol (96 per cent). |
| Vapor Presure | 9.86E-17mmHg at 25°C |
| Appearance | neat |
| Color | White |
| Storage Condition | 2-8°C |
| Use | For the treatment of gastrointestinal spasm |
trimebutine maleate - Risk and Safety
| Hazard Symbols | C - Corrosive |
| Risk Codes | 34 - Causes burns |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S27 - Take off immediately all contaminated clothing. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| WGK Germany | 2 |
| RTECS | DI0360000 |
trimebutine maleate - Standard
Authoritative Data Verified Data
This product is (±)-3,4, 5-trimethoxybenzoic acid (2-dimethylamino-2-phenyl) butyl ester maleate. Calculated as dried product, containing no less than 99.0% of C22H29NO5 • C4H4O4.
Last Update：2024-01-02 23:10:35
trimebutine maleate - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; Odorless.
- This product is dissolved in methanol or acetonitrile, slightly soluble in water or anhydrous ethanol, almost insoluble in ether; Soluble in glacial acetic acid.
melting point
The melting point of this product (General 0612) is 130~134.
Last Update：2022-01-01 11:31:26
trimebutine maleate - Differential diagnosis
Authoritative Data Verified Data
- take about 50mg of this product, add 5ml of water, and dissolve it with slight heat. Add 5 drops of ammonium chromium cyanide solution Dropwise to generate light red precipitate.
- take about 10mg of this product, add dilute hydrochloric acid lm l and water 4ml to dissolve, then add 1 drop of potassium permanganate solution, and the purple color will disappear.
- take an appropriate amount of this product and use 0. The Olmol/L hydrochloric acid solution is prepared as a solution containing about 20FXG of trimebutine maleate per 1 ml, and has a maximum absorption at a wavelength of 0401 nm as measured by ultraviolet-visible spectrophotometry (general rule).
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 725).
Last Update：2022-01-01 11:31:26
trimebutine maleate - Exam
Authoritative Data Verified Data
acidity
take this product o.5g, add water 50ml, slightly heat to dissolve, cold, measured according to law (General rule 0631),pH value should be 3.5~5.0.
solution clarity and color
take 0.5g of this product, add 50ml of water, slightly heat to dissolve, the solution should be clear and colorless.
chloride
take 0,5g of this product and check it according to law (General rule 0801). Compared with the control solution made of 5.0 ml of standard sodium chloride solution, it should not be more concentrated (0.01%).
cyanide
take this product 0806G, inspection according to law (general principles the first law), should comply with the provisions.
Related substances
take this product about O.lg, accurately weigh and set in] OOml measuring flask, tn appropriate amount of mobile phase, shake to dissolve trimebutine maleate, dilute to the scale with mobile phase, shake well, as a test solution; accurately weigh the appropriate amount of 3,4, 5-trimethoxybenzirane reference substance, add mobile phase to dissolve and quantitatively dilute to make it contain about 1 per 1 ml. 0 mg of the solution, as a reference solution; Precision take the control solution and the test solution of each 1 ml, put in the same 200ml measuring flask, diluted with mobile phase to scale, sowing, as a control solution. The control solution (1 ml) was accurately weighed, placed in a 50ml measuring flask, diluted to the scale with mobile phase, and shaken to obtain a sensitivity solution. According to the high performance liquid chromatography (General rule 0512> test, silica gel bonded with eighteen alkyl silane was used as the filler; The pH value was adjusted to 0.43 with buffer solution (3.75±0 of perchloric acid and of water). 05, diluted with water to 1000ml, add sodium pentanesulfonate 1.54g shaking to dissolve, obtained)-acetonitrile (65:35) as mobile phase; Detection wavelength was 268nm. The number of theoretical plates shall not be less than 3000 calculated by trimebutine peak, and the separation degree between trimebutine peak and adjacent impurity peaks shall meet the requirements. 20ul of sensitivity solution shall be injected into human liquid chromatograph, and the signal-to-noise ratio of main component peak height shall be greater than 10; Then 20ul of sample solution, reference solution and control solution shall be accurately measured and injected into human liquid chromatograph respectively, record the chromatogram to 2 times of the retention time of the main component chromatographic peak. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of 3,4, 5-trimethoxybenzoyl in the control solution, the peak area shall not exceed 0.5% based on the external standard method, and the peak area of other single impurities (excluding maleic acid peak) shall not be greater than 0.4 times (0.2%) of the peak area of trimebutine in the control solution, the sum of peak areas of other impurities (excluding the maleic peak) shall not be greater than 1.5 times (0.75%) The Peak area of trimebutine in the control solution.
residual solvent
take an appropriate amount of this product, weigh it accurately, add N,N-dimethylformamide to dissolve and dilute to make trimebutine maleate 0.lg of the solution, as the test solution; Another ethanol, isopropanol, N-hexane, Tetrahydrofuran, benzene and toluene each appropriate Halo, precision weighing, plus N,N-dimethylformamide is dissolved and diluted into a mixed solution containing about 0.5mg of fermentation broth, 0.5mg of propofol, 0.029mg of normal fermentation broth, 0.072mg of tetrahydrofuran, 0.0002mg of benzene and 0.089mg of toluene per 1 ml, as a control Crystal solution. 5ml of each of the test solution and the reference solution were accurately measured, respectively placed in the headspace bottle and sealed. According to the determination method of residual solvent (General rule 0861 second method>, the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane as stationary liquid is used as the column; The initial temperature is 40°C, and the maintenance time is 5 minutes, the temperature was raised to 180°C at a rate of 10°C per minute for 5 minutes; The inlet temperature was 200°C, the detector temperature was 250°C, and the split ratio was 5:1; the equilibrium temperature of the headspace bottle was 80°C; The equilibrium time was 30 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree of each component peak shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. Based on the peak area calculated by external standard method, the residues of ethanol, isopropanol, n-hexane, Tetrahydrofuran, benzene and toluene shall meet the requirements.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (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 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
arsenic salt
take about 2g of anhydrous sodium carbonate, spread on the bottom and surrounding of platinum crucible, Take 2.OG of this product, put on anhydrous sodium carbonate, add a small amount of water to wet the sea, after drying, burn with small fire to make charring, after burning at 5OO-600°C to ash, repeat the number of operations from "adding a small amount of water to wet" until complete ashing and cooling, add appropriate amount of water, add salt to dissolve the residue and make the solution neutral, then add 5ml of hydrochloric acid, add water to make 28ml, check according to law (General Principles 0822 first law), should comply with the regulations (0.0001%).
Last Update：2022-01-01 11:31:28
trimebutine maleate - Content determination
Authoritative Data Verified Data
take this product about 0.4g, precision weighing, add glacial acetic acid 40ml dissolved, add crystal violet indicator 1 drop, with high oxygen acid titration solution (0.1mol/L) the titration was carried out until the solution appeared blue-green, and the results of the titration were corrected by a blank test. Each 1 ml of perchloric acid titrant (0.1mol /L) corresponds to 50.35mg of c22h29n0.5 c4h404.
Last Update：2022-01-01 11:31:28
trimebutine maleate - Category
Authoritative Data Verified Data
antispasmodic.
Last Update：2022-01-01 11:31:28
trimebutine maleate - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 11:31:28
trimebutine maleate - Trimebutine Maleate Tablets
Authoritative Data Verified Data
trimebutine Maleate (C22H29NO5 • C4H404) should be 93.0% ~ 107.0% of label amount.
trait
This product is white, white or film-coated tablets, white or white after removing the coating.
identification
- take an appropriate amount of the fine powder of this product (about 50mg equivalent to trimebutine maleate), add 5ml of water, fully shake to dissolve trimebutine maleate, filter, take the filtrate and add 5 drops of ammonium chromium thiocyanate test solution, the formation of light red precipitate,
- take an appropriate amount of the fine powder (about equivalent to trimebutine maleate lOOmg), add 10ml of water, fully shake to dissolve trimebutine maleate, filter, and take 5ml of the filtrate, add 1 drop of potassium permanganate solution, the purple color will disappear,
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution,
- take an appropriate amount of the fine powder of this product, make a solution containing about 20ug of trimebutine maleate per 1 ml with 0.01mol/L hydrochloric acid solution, filter, the filtrate was measured by UV-Vis spectrophotometry (General 0401), and had a maximum absorption at a wavelength of 267nm.
examination
- Related substances take an appropriate amount of this product's fine powder (about equivalent to trimebutine maleate lOOmg) for precision weighing, place it in a 100ml measuring flask, and add an appropriate amount of mobile phase, shake to dissolve trimebutine maleate, dilute to the scale with mobile phase, shake well> filter, and take the continued filtrate as the test solution; Weigh 3,4 precisely, the 5-trimethoxybenzoic acid control was dissolved in an appropriate amount by adding mobile phase and quantitatively diluted to make about 1 per 1 ml. 0 mg of the solution was used as a reference solution; 1ml of each of the reference solution and the test solution was accurately measured, placed in the same 200ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. Take 1ml of the control solution in a 50ml measuring flask, dilute to the scale with the mobile phase, and shake to obtain the sensitivity solution. Determination of related substances according to trimebutine maleate method. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of 3,4, 5-trimethoxybenzoic acid in the control solution, the peak area shall be calculated according to the external standard method, not 0.5% of the labeled amount of trimebutine maleate, other individual impurities (other than the maleic acid peak) Peak area shall not be greater than the control solution of trimebutine peak area (0.5%), other impurities (other than the maleic acid peak) the sum of peak areas must not be greater than 1.5 times (0.75%) The Peak area of trimebutine in the control solution.
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with hydrochloric acid solution (0.09-1000ml) 1000ml as the dissolution medium, the rotation speed is 50 revolutions per minute, and the operation is carried out according to law. After 30 minutes, 10ml of the solution is taken, filtered, and the appropriate amount of the filtrate is accurately taken and diluted quantitatively with the dissolution medium to make a solution containing about 20ug per lml, as a test solution; In addition, an appropriate amount of trimebutine maleate reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 20ug per 1 ml as a reference 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 85% 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Buffer solution (take perchloric acid 0.43ml, add water 950ml, mix well, adjust the pH value to 3.75±0.05 with ammonium acetate test solution, it was diluted to 1000ml with water, and 1.54g of sodium pentanesulfonate was added to dissolve by shaking to obtain-acetonitrile (65:35) as mobile phase; The detection wavelength was 268nm. The number of theoretical plates shall not be less than 3000 calculated by trimebutine peak, and the separation degree between trimebutine peak and adjacent impurity peaks shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about equivalent to trimebutine maleate lOOmg ), put in a 100ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve trimebutine maleate, dilute to scale with mobile phase, shake well, filter, Take 5ml of filtrate accurately, put it in a 25ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, accurately measure 20ul and inject it into human liquid chromatograph, record the chromatogram; Take an appropriate amount of trimebutine maleate reference, precisely weigh it, the mobile phase was added and dissolved and diluted to prepare a control solution containing about 0.2mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as trimebutine maleate.
specification
(1)0.lg (2 )0.2g
storage
sealed and stored in a dry place.
Last Update：2022-01-01 11:31:30
trimebutine maleate - Trimebutine maleate capsules
Authoritative Data Verified Data
trimebutine Maleate (C22H29NO5 • C4H404) should be 93.0% ~ 107.0% of label amount.
trait
The content of this product is white particles or powder.
identification
- take an appropriate amount of the contents of this product (about 50mg of trimebutine maleate), add 5ml of water, fully shake to dissolve trimebutine maleate, filter, take the filtrate and add 5 drops of ammonium chromium thiocyanate test solution, that is, a light red precipitate is formed.
- take an appropriate amount of the contents of this product (about equivalent to trimebutine maleate lOOmg ), add 10ml of water, fully shake to dissolve trimebutine maleate, filter, and take 5ml of filtrate, add 1 drop of potassium permanganate solution and the purple color will disappear.
- in the chromatogram recorded under the content determination item, 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 an appropriate amount of the contents of this product and use 0.Olmol / L hydrochloric acid solution is made into a solution containing about 20ug of trimebutine maleate per 1 ml, filtered, and the filtrate is taken for determination by UV-Vis spectrophotometry (General 0401), there is an absorption maximum at a wavelength of 267nm.
examination
- Related Substances: take an appropriate amount of the contents of this product (about equivalent to trimebutine maleate lOOmg) for precision weighing, place it in a 100ml measuring flask, and add an appropriate amount of mobile phase, dissolve trimebutine maleate by shaking, dilute to the scale with mobile phase, shake well, filter, and take the continued filtrate as the test solution; Weigh 3,4 precisely, the appropriate amount of 5-trimethoxybenzoic acid reference substance was dissolved by adding mobile phase and diluted quantitatively to make a solution containing about 1.0mg per 1ml, which was used as the reference solution, in the same 200M l measuring flask, dilute to the scale with mobile phase, shake, as a control solution. Take 1ml of the control solution in a 50ml measuring flask, dilute to the scale with the mobile phase, and shake to obtain the sensitivity solution. Determination of related substances according to trimebutine maleate method. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of 3,4, 5-trimethoxybenzoic acid in the control solution, the peak area shall be calculated according to the external standard method, 0.5% of the labeled amount of trimebutine maleate shall not be passed; The peak area of other individual impurities (except the maleic acid peak) shall not be greater than the peak area of trimebutine in the control solution (0.5%), other impurities (except the maleic acid peak) the sum of peak areas must not be greater than 1.5 times (0.75%) The Peak area of trimebutine in the control solution.
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with hydrochloric acid solution (0.09-1000ml) 1000ml as the dissolution medium, the rotation speed is 50 revolutions per minute, and the operation is carried out according to law. After 30 minutes, 10ml of the solution is taken, filtered, and the appropriate amount of the filtrate is accurately taken and diluted quantitatively with the dissolution medium to make a solution containing about 20ug per lml, as a test solution; In addition, an appropriate amount of trimebutine maleate reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 20ug per 1 ml as a reference 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 particle was calculated. The limit is 85% 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Buffer solution (take perchloric acid 0.43ml, add water 950ml, mix well, adjust the pH value to 3.75±0.05 with ammonium acetate test solution, it was diluted to 1000ml with water, and 1.54g of sodium pentanesulfonate was added to dissolve by shaking to obtain-acetonitrile (65:35) as mobile phase; The detection wavelength was 268nm. The number of theoretical plates shall not be less than 3000 calculated by trimebutine peak, and the separation degree between trimebutine peak and adjacent impurity peaks shall meet the requirements.
- determine the contents under the item of loading difference, grind them finely, weigh appropriately (about equivalent to trimebutine maleate lOOmg ), put them in a 100ml measuring flask, and add appropriate amount of mobile phase, shake to dissolve trimebutine maleate, dilute to scale with mobile phase, shake well, filter, Take 5ml of filtrate accurately, put it in a 25ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, inject 20u1 into the liquid chromatograph with precise volume, record the chromatogram; Take an appropriate amount of trimebutine maleate reference, the mobile phase was added and dissolved and diluted to prepare a control solution containing about 0.2mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as trimebutine maleate.
specification
O.lg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 11:31:31
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CAS: 34140-59-5
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