chlorphenamine hydrogen maleate
chlorphenamine hydrogen maleate
CAS: 113-92-8
Molecular Formula: C20H23ClN2O4
chlorphenamine hydrogen maleate - Names and Identifiers
| Name | chlorphenamine hydrogen maleate |
| Synonyms | Histadur Cloropiril Chlorophenamine but-2-enedioic acid CHLORPHENIRAMINE MALEATE Chloropheniramine maleate Chlorprophenpyridamine maleate chlorphenamine hydrogen maleate 3-(4-chlorophenyl)-N,N-dimethyl-3-(2-pyridyl)propan-1-amine 3-(4-chlorophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amine 1-Parachlorophenyl-1-(2-pyridyl)-3-dimethylaminopropane maleate 1-(p-Chlorophenyl)-1-(2-pyridyl)-3-dimethy-laminopropanebimaleate 3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine (2E)-but-2-enedioate 3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine (2Z)-but-2-enedioate (3R)-3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine (2Z)-but-2-enedioate |
| CAS | 113-92-8 |
| EINECS | 204-037-5 |
| InChI | InChI=1/C16H19ClN2.C4H4O4/c1-19(2)12-10-15(16-5-3-4-11-18-16)13-6-8-14(17)9-7-13;5-3(6)1-2-4(7)8/h3-9,11,15H,10,12H2,1-2H3;1-2H,(H,5,6)(H,7,8) |
| InChIKey | DBAKFASWICGISY-BTJKTKAUSA-N |
chlorphenamine hydrogen maleate - Physico-chemical Properties
| Molecular Formula | C20H23ClN2O4 |
| Molar Mass | 390.86 |
| Density | 1.1984 (rough estimate) |
| Melting Point | 130-135 °C (lit.) |
| Boling Point | 579.3°C at 760 mmHg |
| Specific Rotation(α) | -1～+1°(D/20℃)(c=5,DMF) |
| Flash Point | 9℃ |
| Water Solubility | 1-5 g/100 mL at 21 ºC |
| Solubility | Easily soluble in water, ethanol, chloroform, slightly soluble in ether |
| Vapor Presure | 2.9E-14mmHg at 25°C |
| Appearance | White crystalline powder |
| Color | White to Almost white |
| Merck | 14,2180 |
| PH | 4.0～5.5 (10g/l, 25℃) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.6800 (estimate) |
| MDL | MFCD00069225 |
| Physical and Chemical Properties | White crystalline powder. Melting point 131-135 °c. Soluble in water, ethanol, chloroform, slightly soluble in ether, odorless, bitter taste. |
| Use | Used as an anti-allergic drug |
chlorphenamine hydrogen maleate - Risk and Safety
| Risk Codes | R25 - Toxic if swallowed R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | 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.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | US6504000 |
| TSCA | Yes |
| HS Code | 29333990 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 orally in mice: 162 mg/kg (Smith) |
chlorphenamine hydrogen maleate - Standard
Authoritative Data Verified Data
This product is 2-[p-chloro-a-[2-(dimethylamino) ethyl] phenyl] pyridine maleate. Calculated as dried product, including C16H19C1N2 • C4H404 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
chlorphenamine hydrogen maleate - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is soluble in water or ethanol or chloroform, and slightly soluble in ether.
melting point
The melting point of this product (General 0612) is 131.5~135°C.
absorption coefficient
take this product, precision weighing, add hydrochloric acid solution (dilute hydrochloric acid lml and water to 100ml) to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General Rule 212), and the absorption coefficient was 222.
Last Update：2022-01-01 11:31:48
chlorphenamine hydrogen maleate - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 1ml of test solution of acetic anhydride citrate, and put it in a water bath to heat it, which shows red and purple color.
- take about 20mg of this product, add 1ml of dilute sulfuric acid, drop add potassium permanganate solution, the red color will disappear.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 61).
Last Update：2022-01-01 11:31:48
chlorphenamine hydrogen maleate - Exam
Authoritative Data Verified Data
acidity
take this product o.lg, add water 10ml to dissolve, according to the law to determine (General 0631 ) ,pH value should be 4.0~5.0.
Related substances
take this product, add solvent [mobile phase A- acetonitrile (80:20)] to dissolve and dilute to prepare A solution containing 1 mg per 1ml as A test solution; an appropriate amount was taken in a precise amount and diluted with the above solvent to prepare a solution containing 3ug per 1ml as a control solution. According to the high performance liquid chromatography (General 0512) test, with eighteen alkyl silane bonded silica gel as filler, mobile phase A is phosphate buffer (take ammonium dihydrogen phosphate 11.5g, add appropriate amount of water to dissolve, add phosphoric acid 1ml, diluted with water to 1000ml ), mobile phase B was acetonitrile, and gradient elution was carried out according to the following table at a flow rate of 1.2ml per minute and a detection wavelength of 225mn. The number of theoretical plates shall not be less than 4000 based on the calculation of chlorpheniramine peak. The sample solution and the control solution were respectively injected with human liquid chromatography, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, except for the maleic acid peak, the area of a single impurity peak shall not be greater than the area of chlorpheniramine peak in the control solution (0.3%), the sum of the peak areas of each impurity shall not be greater than 3 times (0.9%) The Peak area of chlorpheniramine in the control solution. Test Solution chromatogram less than the control solution chlorpheniramine Peak area of 0.17 times the chromatographic peak is negligible (0.05%).
residual solvent
take this product, precision weighing, add N,N-dimethylformamide to dissolve and dilute to make a solution containing about 0.2g per 1 ml, as a test solution; Take Tetrahydrofuran, 1,4-dioxane, pyridine and toluene, precision weighing, with N, dimethylformamide quantitative dilution made each 1ml containing tetrahydrofuran 144ugl, 4-dioxane 76ug, pyridine 40ug, toluene 178UG solution, as a control solution. 1ml of each of the test solution and the reference solution was accurately measured, placed in the headspace bottle, and sealed. According to the determination method of residual solvent (General Principle 0861 second method), 5% phenyl-95% methyl polysiloxane (or polar similar) is used as the stationary liquid; The column temperature is maintained at 50°C for 15 minutes, the temperature was then increased to 120°C at a rate of 8°C per minute for 10 minutes; The inlet temperature was 200°C; And the detector temperature was 250°C. The Headspace vial equilibration temperature was 90°C, the equilibration time was 30 minutes, and the injection volume was 1.0ml. Take the reference solution for Headspace injection, and the number of theoretical plates shall not be less than 5000 based on the tetrahydrofuran peak. The separation degree between peaks of each component shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. Based on peak area calculation by external standard method, the residues of tetrahydrofuran, dioxane, pyridine and toluene shall comply with the regulations.
easily carbonized
take 25mg of this product, check according to law (General rule 0842), compared with the yellow No. 1 Standard Colorimetric solution, not deeper.
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
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 11:31:49
chlorphenamine hydrogen maleate - Content determination
Authoritative Data Verified Data
take this product about 0.15g, precision weighing, add glacial acetic acid 10ml dissolved, add crystal violet indicator liquid 1 drop, with perchloric acid titration solution (0.1 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 19.54mg of C16H19C1N2 • C4H4O4.
Last Update：2022-01-01 11:31:50
chlorphenamine hydrogen maleate - Category
Authoritative Data Verified Data
antihistamines.
Last Update：2022-01-01 11:31:50
chlorphenamine hydrogen maleate - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:31:50
chlorphenamine hydrogen maleate - Chlorpheniramine Maleate Tablets
Authoritative Data Verified Data
This product contains chlorpheniramine maleate (C16H19CIN2 • C4H404) should be 93.0% ~ 107.0% of the label amount.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 8mg equivalent to chlorpheniramine maleate), add 4ml of water, stir, filter, and evaporate the filtrate to dryness, and perform the identification (1) Test under the item of chlorpheniramine maleate, the same reaction was shown.
- take an appropriate amount of fine powder of this product (about 20mg equivalent to chlorpheniramine maleate), add 2ml of dilute sulfuric acid, stir, filter, add potassium permanganate solution to the filtrate drop, and the red color will disappear.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
examination
- Content uniformity take 1 tablet of this product, put it in a measuring flask of 25ml(lmg specification) or 50ml ( 4mg specification), add about 20ml of mobile phase, shake and disintegrate, and dissolve chlorpheniramine maleate, dilute to scale with mobile phase, shake, filter, take filtrate 20ul(lmg specification) or 10ul( 4mg specification), and determine the content according to the method under the content determination item, the provisions shall be met (General rule 0941).
- dissolution: according to the dissolution and release determination method (General rule 0931 method), dilute hydrochloric acid ML and water 250ml are used as the solvent, and the rotation speed is 50 rpm, after 45 minutes, 10ml of the solution was filtered, and the filtrate was taken, and the absorbance was measured at the wavelength of 0401 nm by UV-visible spectrophotometry (general rule), the elution amount of each tablet was calculated as an absorption coefficient of C16H19C1N2 • C4H404 of 217. 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer (take ammonium dihydrogen phosphate 11.5g, add appropriate amount of water to dissolve, add phosphoric acid 1ml, dilute to 1000ml with water)-Acetonitrile (80:20) as mobile phase; Column temperature was 30°C; Detection wavelength was 262mn. The order of peak emergence is maleic acid and chlorpheniramine, and the number of theoretical plates is not less than 4000 according to the calculation of chlorpheniramine peak. The separation degree of chlorpheniramine peak and adjacent impurity peaks shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine, precision weighing an appropriate amount (equivalent to 4mg of chlorpheniramine maleate), put in a 50ml measuring flask, add an appropriate amount of mobile phase, chlorpheniramine maleate was dissolved by shaking, diluted to scale with mobile phase, shaken, filtered, and the continuous filtrate was taken as the test solution. Lol was injected into the liquid chromatograph with precise volume, and the chromatogram was recorded; another 16mg chlorpheniramine maleate reference substance was added into a 200ml measuring flask, dissolved with mobile phase and diluted to the scale. According to the external standard method, the peak area of chlorpheniramine was calculated.
category
with chlorpheniramine maleate.
specification
(l)lmg (2)4mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:31:51
chlorphenamine hydrogen maleate - Chlorphenamine Maleate Injection
Authoritative Data Verified Data
This product is a sterilized aqueous solution of chlorpheniramine maleate. Containing chlorpheniramine maleate (C16H19C1N2.C4H404) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product (about 30mg equivalent to chlorpheniramine maleate), put it on a water bath and evaporated to dryness, and then show the same reaction according to the identification (1) and (2) tests under the item of chlorpheniramine maleate.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
examination
- the pH value should be 4.0 to 5.0 (General 0631).
- for related substances, take the test solution under the content determination item as the test solution; Take 1ml of precision measurement, put it in a 100ml measuring flask, dilute it to the scale with water, and shake it well, as a control solution. According to the chromatographic condition test under the content determination item, 10 u1 of the control solution and 10 u1 of the test solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 2 times of the retention time of the chlorpheniramine 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 chlorpheniramine peak area in the control solution (1.0%) except the maleic acid peak and the chlorpheniramine peak.
- bacterial endotoxin take this product, according to the law inspection (General 1143), per 1 mg of chlorpheniramine maleate in the amount of endotoxin should be less than 5.0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using octyl silane bonded silica gel as filler; Acetonitrile-aqueous solution containing 5% phosphoric acid and 5% triethylamine (20:80) as mobile phase; the detection wavelength was 262NM. The order of peak emergence is maleic acid and chlorpheniramine, and the number of theoretical plates is not less than 4000 according to the calculation of chlorpheniramine peak. The separation degree of chlorpheniramine peak and adjacent impurity peaks shall meet the requirements.
- determination: take 2ml of this product, put it in a 25ml measuring flask, dilute it to the scale with water, shake it well, and use it as a test solution, water was added to dissolve and quantitatively diluted to prepare a solution containing about 0.8mg per 1 ml as a control solution. Take 10 u1 of each of the reference solution and the test solution, respectively inject the human liquid chromatograph, and record the chromatogram. According to the external standard method, the peak area of chlorpheniramine was calculated.
category
with chlorpheniramine maleate.
specification
- lml:10mg
- 2ml:20mg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:31:52
chlorphenamine hydrogen maleate - Chlorphenamine maleate dropping pills
Authoritative Data Verified Data
This product contains chlorpheniramine maleate (C16H19CIN2 • C4H404) should be 93.0% ~ 107.0% of the label amount.
trait
This product is a white or off-white pill.
identification
- take this product (about 8mg equivalent to chlorpheniramine maleate), add 1ml test solution of acetic anhydride citrate, and heat it on a water bath to show red and purple color.
- take this product (about 20mg equivalent to chlorpheniramine maleate), add 2ml of dilute sulfuric acid to dissolve chlorpheniramine maleate, add potassium permanganate solution Dropwise, and the red color will disappear.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
examination
- Related substances take this product, add solvent [mobile phase A- acetonitrile (80:20)] to dissolve and make A solution containing 1 mg of chlorpheniramine maleate per 1 ml, filter, the filtrate was taken as the test solution; An appropriate amount was taken in a precise amount and diluted with the same solvent to prepare a solution containing 5ug of chlorpheniramine maleate per 1 ml as a control solution. If there are impurity peaks in the chromatogram of the test solution, except for the peak of maleic acid and the peak of auxiliary material (polyethylene glycol 6000), the Peak area of a single impurity shall not be greater than that of chlorpheniramine in the control solution (0.5% ) , and the sum of the peak areas of each impurity shall not be greater than 2 times (1.0%) The Peak area of chlorpheniramine in the control solution.
- Content uniformity: Take 1 pill of this product, put it in a measuring flask of 25ml ( 2mg specification) or 50ml( 4mg specification), add about 20ml of mobile phase, shake and collapse, and dissolve chlorpheniramine maleate by ultrasound, dilute with mobile phase to the scale, shake, filter, take and continue filtrate content determination method under the item of content determination, should comply with the provisions (General 0941).
- others shall comply with the relevant provisions under the pill (General rule 0108).
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; Phosphate buffer (take ammonium dihydrogen phosphate 11.5g, add appropriate amount of water to dissolve, add phosphoric acid 1ml, dilute to 1000ml with water)-Acetonitrile (80:20) as mobile phase; Column temperature was 30°C; Detection wavelength was 262NM. The order of peak emergence is maleic acid and chlorpheniramine, and the number of theoretical plates is not less than 4000 according to the calculation of chlorpheniramine peak. The separation degree of chlorpheniramine peak and adjacent impurity peaks shall meet the requirements.
- determination Method: Take 20 pills of this product, precise weighing, fine grinding, precise weighing appropriate amount (about 4mg equivalent to chlorpheniramine maleate), put it in a 50ml measuring flask, add appropriate amount of mobile phase, ultrasonic to dissolve chlorpheniramine maleate, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution, take a 10ul injection liquid chromatograph with precision, record the chromatogram; Take 16mg of chlorpheniramine maleate reference substance, precision weighing, 200ml flask, and mobile phase dissolved and diluted to the scale, shake, the same method. According to the external standard method, the peak area of chlorpheniramine was calculated.
category
with chlorpheniramine maleate.
specification
(l)2mg (2)4mg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:31:53
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Product Name: Chlorphenamine Maleate Visit Supplier Webpage Request for quotationCAS: 113-92-8
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: chlorphenamine hydrogen maleate Request for quotation
CAS: 113-92-8
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 113-92-8
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Chlorpheniramine Maleate Visit Supplier Webpage Request for quotationCAS: 113-92-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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