3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride
clomipramine hydrochloride
CAS: 17321-77-6
Molecular Formula: C19H24Cl2N2
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Names and Identifiers
| Name | clomipramine hydrochloride |
| Synonyms | Clomipramine HCl CLOMIPRAMINE HCL Chloroimipram-ine HCl CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CHLORIMIPRAMINE HYDROCHLORIDE CHLOROIMIPRAMINE HYDROCHLORIDE 3-chloroimipraminehydrochloride 3-chloro-5-(3-(dimethylamino)propyl)-10,11-dihydro-5h-dibenz(b,f)azepinemono 3-CHLORO-10,11-DIHYDRO-N,N-DIMETHYL-5H-DIBENZ[B,F]AZEPINE-5-PROPANAMINE HYDROCHLORIDE 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride |
| CAS | 17321-77-6 |
| EINECS | 241-344-3 |
| InChI | InChI=1/C19H23ClN2.ClH/c1-21(2)12-5-13-22-18-7-4-3-6-15(18)8-9-16-10-11-17(20)14-19(16)22;/h3-4,6-7,10-11,14H,5,8-9,12-13H2,1-2H3;1H |
| InChIKey | WIMWMKZEIBHDTH-UHFFFAOYSA-N |
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Physico-chemical Properties
| Molecular Formula | C19H24Cl2N2 |
| Molar Mass | 351.31 |
| Melting Point | 189-190°C |
| Boling Point | 434.2°C at 760 mmHg |
| Flash Point | 9℃ |
| Solubility | H2O: 25mg/mL |
| Vapor Presure | 9.63E-08mmHg at 25°C |
| Appearance | White to slightly yellow crystalline powder |
| Color | white to off-white |
| PH | 3.5～5.0（100g/l，25℃） |
| Storage Condition | 2-8°C |
| Sensitive | Sensitive to heat and light |
| MDL | MFCD00069234 |
| Use | Used as an antidepressant |
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Risk and Safety
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S36 - Wear suitable protective clothing. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. S7 - Keep container tightly closed. S62 - If swallowed, do not induce vomitting; seek medical advice immediately and show this container or label. S38 - In case of insufficient ventilation, wear suitable respiratory equipment. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S28 - After contact with skin, wash immediately with plenty of soap-suds. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S24/25 - Avoid contact with skin and eyes. S22 - Do not breathe dust. S20/21 - S13 - Keep away from food, drink and animal foodstuffs. |
| UN IDs | 3249 |
| WGK Germany | 3 |
| RTECS | HN9055000 |
| HS Code | 2933996100 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Standard
Authoritative Data Verified Data
This product is N, n-dimethyl-10, 11-dihydro-3-chloro-5h-dibenzo [B, f] Nitrogen weed-5-propylamine hydrochloride. Calculated as dry product, containing C19H23C1N2 • HC1 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Odorless; Light color gradient yellow.
- This product is very soluble in chloroform or glacial acetic acid, soluble in water or ethanol, slightly soluble in acetone, almost insoluble in ether.
melting point
The melting point of this product (General rule 0612) is 190~196°C, and the melting distance shall not exceed 2°C.
absorption coefficient
take this product, precision weighing, and hydrochloric acid solution (9-1000) dissolved and quantitatively diluted into about 20ug solution per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General Rule 220), and the absorption coefficient was 233.
Last Update：2022-01-01 15:34:44
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Introduction
Clomipramine HCl, a Clomipramine hydrochloride, inhibits the serotonin transporter (SERT), norepinephrine transporter (NET), and dopamine transporter (DAT) with Ki of 0.14, 54, and 3 nM, respectively.
Last Update：2022-10-16 17:14:25
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, Dropwise add a small amount of nitric acid, that is dark blue.
- Take lg of this product, set it in a separatory funnel, add 10ml of water to dissolve it, add 5ml of sodium hydroxide solution, extract it twice with ether, 30ml each time, combine the ether extract, and add the appropriate amount of anhydrous sodium sulfate, shake, filter, shake off the ether, take the residue about 50mg, add sodium carbonate 0.2g, mix well, burn to full charring, let cool, add water 5ml, boil, let cool, filter, the filtrate shows the reaction of chloride identification (1) (General 0301).
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 842).
- the aqueous solution extracted with diethyl ether under identification (2) was taken to identify the reaction of (1) with chloride (General 0301).
Last Update：2022-01-01 15:34:45
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Exam
Authoritative Data Verified Data
color of solution
take this product l.Og, add water 10ml to dissolve, the solution should be colorless; If the color is colored, compared with the yellow No. 3 Standard Colorimetric solution (General rule 0901 first method), not deeper.
acidity
take 2.0g of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 3.5~5.0.
Related substances
operation in the dark. Take an appropriate amount of this product, add the mobile phase to dissolve and dilute to prepare a solution containing about lmg per lml as a test solution; Take lml for precise measurement, put it in a 100ml measuring flask, dilute it to the scale with the mobile phase, shake, as a control solution; Clomipramine hydrochloride and imipramine hydrochloride control each appropriate amount, and mobile phase dissolved and diluted to make each about 0. A solution of 1 mg, as a system-suitable solution. According to the test of high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as filler; Methanol-1.25% sodium heptane sulfonate solution-1.0% trichloroacetic acid solution-2.5% potassium dihydrogen phosphate solution (330:80:50:40) as mobile phase; The detection wavelength was 251nm; The column temperature was 40°C. Take the system applicable solution 20u1 and inject it into human liquid chromatograph, record the chromatogram, and the number of theoretical plates shall not be less than 2000 based on the clomipramine peak, and the separation degree of clomipramine peak and imipramine peak shall be greater than 4.0. 10 u1 of the control solution and 10 u1 of the test solution were injected into the liquid chromatograph respectively, and the chromatogram was recorded to 2 times of 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%).
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 ignition residue shall not be more than 10 parts per million (ppm) and shall be inspected according to law (General rule 0821 second law).
Last Update：2022-01-01 15:34:46
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, plus ethanol 50ml dissolved, precision plus 0.Olmol/ L hydrochloric acid solution 5ml, according to the potentiometric titration method (General 0701), with sodium hydroxide titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 35.13mg of C19H23C1N2. Hc1.
Last Update：2022-01-01 15:34:46
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Category
Authoritative Data Verified Data
antidepressants.
Last Update：2022-01-01 15:34:46
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:34:46
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Clomipramine Hydrochloride Tablets
Authoritative Data Verified Data
This product contains clomipramine hydrochloride (C19H23C1N2 • HCI) should be 90.0% ~ 110.0% of the label amount.
trait
This product is sugar-coated tablet or film-coated tablet, white to yellowish after removing the coating.
identification
- take an appropriate amount of fine powder of this product, and show the same reaction according to the tests (1), (2) and (4) under the item of hydrochloric acid gas imipramine.
- 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 fine powder of this product and add 0.1 mol / L hydrochloric acid solution is dissolved and made into a solution containing 20ug of clomipramine hydrochloride per 1 ml, filtered, and the filtrate is taken out and determined by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 252nm and a shoulder at a wavelength of 270 to 280nm.
examination
- the related substances were protected from light. Take an appropriate amount of fine powder of this product, add mobile phase to dissolve and dilute to prepare a solution containing lmg clomipramine hydrochloride in each lml, shake well, filter, and take the continued filtrate as the test solution; take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as a control solution. Take the appropriate amount of clomipramine hydrochloride and imipramine hydrochloride, the mobile phase was added and dissolved and diluted to make about 0. A solution of 1 mg, as a system-suitable solution. The determination was carried out according to the method for related substances of clomipramine hydrochloride. If there is a chromatographic peak consistent with the retention time of imipramine hydrochloride in the chromatogram of the test solution, the bee area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, other single impurity peak area shall not be greater than the main peak area of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution.
- Content uniformity take 1 tablet of this product, put it in a 50ml measuring flask, add appropriate amount of mobile phase, ultrasonic dissolve hydrochloric acid gas imipramine, let it cool, dilute it to the scale with mobile phase, shake well, filtration, precision take the appropriate amount of filtrate, quantitative dilution with mobile phase made per lml containing about clomipramine hydrochloride 0.lmg solution, according to the determination of the method under the item, should comply with the provisions (General 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol / L hydrochloric acid solution 1000ml ( 25mg specification) or 500ml (10mg specification) as dissolution medium, speed of 75 rpm, operated according to law, 30 minutes (sugar-coated tablets) or 20 minutes (film-coated tablets) at the same time, take the appropriate amount of the solution, filter, take the filtrate according to UV-visible spectrophotometry (General rule 0401 ), measure the absorbance at the wavelength of 252mn; Take the clomipramine hydrochloride control, precision weighing, add 0.1 mol / L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 25ug( 25mg specification) or 20ug(10mg specification) per 1 ml, shaken, measured by the same method, and the dissolution amount of each tablet was calculated. The limit is 80% 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; Methanol -1.25% sodium heptane sulfonate solution-1.0% trichloroacetic acid solution-2.5% potassium dihydrogen phosphate solution (330:80:50:40) as mobile phase; The detection wavelength was 251nm; The column temperature was 40°C. Take the appropriate amount of the reference substance of hydrochloric acid gas imipramine and imipramine hydrochloride, add the mobile phase to dissolve and dilute to make about 0.lmg solution, 20u1 injection human liquid chromatography, theoretical plate number according to clomipramine peak is not less than 2000, clomipramine peak and imipramine peak separation degree should be greater than 4.0.
- The assay was operated in the dark. Take 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to hydrochloric acid gas imipramine 50mg ), put in 50ml measuring flask, add appropriate amount of mobile phase, dissolve hydrochloric acid gas imipramine by ultrasound, cool, dilute to scale with mobile phase, shake well, filter, Take 5ml filtrate accurately, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, take 20u1 injection of human liquid chromatograph for precise measurement, record chromatogram; Take clomipramine hydrochloride reference substance, precise weighing, the mobile phase was added for dissolution and quantitative dilution to prepare a solution containing 0.lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
with clomipramine hydrochloride.
specification
(l )10mg (2)25mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:34:47
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride - Clomipramine hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of clomipramine hydrochloride. The content of clomipramine hydrochloride (C19H23C1N2 • HCl) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is colorless or almost colorless clear liquid.
identification
- take an appropriate amount of this product and add nitric acid to show a dark blue color.
- light-shielding operation. Take an appropriate amount of this product and dilute it with methanol to make a solution containing about 2.5mg per 1 ml as a test solution, methanol was added to dissolve and prepare a solution containing about 2.5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 5ul of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with ethyl acetate-glacial acetic acid-hydrochloric acid-water (55:35:5:5) for the development of the solvent, expand, dry, spray with 0.5% potassium dichromate 20% sulfuric acid solution to make color, immediately check. The position and color of the main spot displayed by the test solution should be consistent with the main spot of the control solution.
- 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.
examination
- the pH value should be 3.5 to 5.0 (General 0631).
- the color of this product, according to UV-visible spectrophotometry (General 0401), measured at the wavelength of 420nm, the absorbance should not exceed 0.025.
- the related substances were protected from light. Take this product and dilute it with mobile phase to make a solution containing lmg of clomipramine hydrochloride in each lml as a test solution. Take lml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake, as a control solution; Hydrochloric acid gas imipramine and imipramine hydrochloride control each appropriate amount, and mobile phase dissolved and diluted to make each about 0 in 1 ml. A solution of 1 mg, as a system-suitable solution. If there are impurity peaks in the chromatogram of the test solution, except for the peaks with relative retention time less than 0.25, the single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than 1.2 times (1.2%) of the main peak area of the control solution.
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg clomipramine hydrochloride containing endotoxin amount should be less than 2.0EU.
- others should comply with the relevant provisions under injection (General 0102).
determination of content
- light-shielding operation. According to high performance liquid chromatography (General 0512) determination.
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol -1.25% sodium heptane sulfonate solution-1.0% trichloroacetic acid solution-2.5% potassium dihydrogen phosphate solution (330:80:50:40) as mobile phase; The detection wavelength was 251nm; The column temperature was 40°C. Take the appropriate amount of each reference substance of hydrochloric acid gas imipramine and hydrochloric acid imipramine, add mobile phase to dissolve and dilute to make about 0.lmg solution, 20u1 injection human liquid chromatography, theoretical plate number according to clomipramine peak is not less than 2000, clomipramine peak and imipramine peak separation degree should be greater than 4.0.
- determination of precision take an appropriate amount of this product, quantitative dilution with mobile phase made of clomipramine hydrochloride in about each lml 0.lmg solution, as a test solution, the precision of 20u1 injection of human liquid chromatography, recording chromatogram; Another clomipramine hydrochloride reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
with clomipramine hydrochloride.
specification
2ml:25mg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:34:48
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View History
3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5h-dibenz[b,f]azepine monohydrochloride
Leptophos phenol
649748-93-6
69616-41-7
(R)-2-tert-butyl 8a-methyl 6-oxo-3,4,6,7,8,8a-hexahydroisoquinoline-2,8a(1H)-dicarboxylate
Carbanilic acid,m-hydroxy-, methyl ester, (1,1,3,3-tetramethylbutyl)carbamate (ester) (8CI)
1201657-76-2
3-Amino-n,n-diethyl-4-(4-methylpiperazin-1-yl)benzene-1-sulfonamide
Diazene, 1-(2,4-dimethoxyphenyl)-2-(4-methylphenyl)-
1,2,3-Triazine, 4-(2,4-dimethyl-1H-pyrrol-3-yl)-2-ethyl-2,5-dihydro-6-methyl-
Leptophos phenol
649748-93-6
69616-41-7
(R)-2-tert-butyl 8a-methyl 6-oxo-3,4,6,7,8,8a-hexahydroisoquinoline-2,8a(1H)-dicarboxylate
Carbanilic acid,m-hydroxy-, methyl ester, (1,1,3,3-tetramethylbutyl)carbamate (ester) (8CI)
1201657-76-2
3-Amino-n,n-diethyl-4-(4-methylpiperazin-1-yl)benzene-1-sulfonamide
Diazene, 1-(2,4-dimethoxyphenyl)-2-(4-methylphenyl)-
1,2,3-Triazine, 4-(2,4-dimethyl-1H-pyrrol-3-yl)-2-ethyl-2,5-dihydro-6-methyl-