23327-57-3
nefopam hydrochloride
CAS: 23327-57-3
Molecular Formula: C17H20ClNO
23327-57-3 - Names and Identifiers
23327-57-3 - Physico-chemical Properties
| Molecular Formula | C17H20ClNO |
| Molar Mass | 289.8 |
| Melting Point | 238-242° |
| Boling Point | 369.5°C at 760 mmHg |
| Flash Point | 109°C |
| Solubility | H2O: soluble5mg/mL, clear |
| Vapor Presure | 1.18E-05mmHg at 25°C |
| Appearance | powder |
| Color | white to beige |
| Storage Condition | 2-8°C |
| Use | Content determination |
| In vitro study | The analgesic mechanism of nefopam is not fully understood, but it should be a central non-opioid analgesic that exerts analgesic effects by inhibiting the reuptake of serotonin, norepinephrine, and dopamine. |
| In vivo study | nefopam was tested intraperitoneally in mice in tail-flick and hot-plate tests (I. p.), Intracranial (I. c.) and intraspinal (I. S.) analgesic activity upon injection. In the hot plate test, the effect of Nefopam is 1/3 of that of morphine, but in the tail-flick test, its effect is similar to that of morphine |
23327-57-3 - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | 23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. |
| 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.) |
| UN IDs | 3249 |
| WGK Germany | 3 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 in mice, rats (mg/kg): 119, 178 orally; 44.5, 28 i.v. (Baltes) |
23327-57-3 - Standard
Authoritative Data Verified Data
This product is 5-methyl -1-phenyl -3,4,5, 6-tetrahydro-1h-2, 5-oxazabenzene hydrochloride. The content of C17H19NO • HCl shall not be less than 98.5% calculated as the dried product.
Last Update：2024-01-02 23:10:35
23327-57-3 - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is slightly soluble in water and slightly soluble in ethanol.
Last Update：2022-01-01 15:06:00
23327-57-3 - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 1ml sulfuric acid, the solution is orange red, add 1 drop of nitric acid, the solution is purple red; Take about 10mg of this product, add 1 drop of sulfuric acid and formaldehyde solution, the solution was Tan.
- take this product and add anhydrous ethanol to make a solution containing 0401 mg per lml, and measure it by UV-visible spectrophotometry (general rule), there is maximum absorption at wavelengths of 266nm and 274NM.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 367).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:06:01
23327-57-3 - Exam
Authoritative Data Verified Data
Related substances
take this product, add water to dissolve and make a solution containing 0.5mg per lml as a test solution; Take 1ml for precision measurement, put it in a 100ml measuring flask, dilute it with water to the scale, as a control solution. Test according to high performance liquid chromatography (General 0512). With eighteen alkyl silane bonded silica gel as filler, with sodium heptane sulfonate solution (take sodium heptane sulfonate 2.02g, add water 900ml to dissolve, add triethylamine 2ml, adjust the pH value to 3.0 with dilute phosphoric acid, add water to 1000ml)-Acetonitrile (70:30) as mobile phase; Detection wavelength of 215nm. The theoretical plate number is not less than 2000 as calculated by the Nefopam peak. 20 u1 of control solution and 20 u1 of test solution were respectively injected into human liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of principal 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 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 15:06:02
23327-57-3 - Content determination
Authoritative Data Verified Data
take this product about 0.15g, precision weighing, add glacial acetic acid 30ml, slightly warm to dissolve, cool, add acetic anhydride 30ml, according to the potential titration method (General 0701), with high gas acid titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 28.98mg of C17H19NO. HCl.
Last Update：2022-01-01 15:06:02
23327-57-3 - Category
Authoritative Data Verified Data
Analgesic.
Last Update：2022-01-01 15:06:02
23327-57-3 - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 15:06:02
23327-57-3 - Nefopam hydrochloride tablets
Authoritative Data Verified Data
This product contains Nefopam hydrochloride (C17H19NO • HCl) should be 90.0% to 110.0% of the label.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 10mg equivalent to Nefopam hydrochloride), add 1ml sulfuric acid, the solution shows yellow, and 1 drop of nitric acid shows red.
- take an appropriate amount of fine powder of this product (about 10mg equivalent to Nefopam hydrochloride), add 1 drop of sulfuric acid 1 ml and formaldehyde solution, that is, Brown.
- take an appropriate amount of fine powder of this product and add anhydrous ethanol to make a solution containing 0401 mg per lml, filter, and take the filtrate for determination by UV-Vis spectrophotometry (general rule), there is maximum absorption at wavelengths of 266nm and 274NM.
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with water 1000ml as the dissolution medium, the speed is 50 rpm, according to the law, after 30 minutes, an appropriate amount of the solution was taken, filtered, and 15ml of the initial filtrate was discarded, and the continued filtrate was taken as the test solution. Another Nefopam hydrochloride reference substance was carefully weighed, dissolved with water and quantitatively diluted to prepare a solution containing 20ug ( 20mg specification) or 30ug(30mg specification) per 1 ml as a reference solution. 20 u1 of the test solution and the reference solution are accurately measured, and the dissolution amount of each tablet is calculated according to the chromatographic conditions under the content determination item. 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; Heptane sulfonate sodium solution (take heptane sulfonate 2.02g, add water 900ml to dissolve, add triethylamine 2ml, the pH value was adjusted to 3.0 with dilute phosphoric acid, and water was added to 1000ml)-acetonitrile (70:30) as mobile phase; The detection wavelength was 215nm. The theoretical plate number is not less than 2000 as calculated by the Nefopam hydrochloride peak.
- determination of this product 20 tablets, precision weighing, fine grinding, precision weighing take appropriate amount (equivalent to Nefopam hydrochloride 20mg ), water was added to dissolve and quantitatively dilute to prepare a solution containing 40ug of Nefopam hydrochloride per 1 ml, and an appropriate amount was centrifuged, and the supernatant was taken as a test solution. Another Nefopam hydrochloride reference substance was carefully weighed, dissolved with water and quantitatively diluted to prepare a solution containing 40ug per 1 ml as a reference solution. 20 u1 of each of the reference solution and the test solution were accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram was recorded. According to the external standard method to calculate the peak area, that is.
category
Same as Nefopam hydrochloride.
specification
(l)20mg (2)30mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:06:03
23327-57-3 - Nefopam hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of Nefopam hydrochloride. Containing Nefopam hydrochloride (C17H19NO.HCl) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take 0.5 of this product, add 1 drop of potassium iodide test solution or Mercury dichloride test solution, and generate white precipitate.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 4.0 to 6.0 (General 0631).
- appropriate amount of the product is taken and diluted with mobile phase to prepare a sample solution containing about 1 mg Nefopam hydrochloride per 1 ml and a control solution containing about 1 mg Nefopam hydrochloride per 1 ml. According to the high performance liquid chromatography (General 0512) test, silica gel was bonded with eighteen alkyl silane as filler; Methanol-water-triethylamine [(38:62:0.5), using glacial acetic acid to adjust the pH value to 4.2] as mobile phase; The detection wavelength was 267nm. The number of theoretical plates shall not be less than 1500 calculated by Nefopam hydrochloride peak, and the separation degree between Nefopam hydrochloride peak and adjacent impurity peaks shall meet the requirements. The 20u1 of the control solution and the test solution were respectively injected into the human liquid chromatograph, 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 (0.30) of the control solution except for the chromatographic peak with relative retention time less than 1.0%.
- bacterial endotoxin this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in Nefopam hydrochloride per 1 mg should be less than 7.5EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product (about 20mg equivalent to Nefopam hydrochloride), put it in a 100ml measuring flask, dilute it to the mark with anhydrous fermentation broth, and shake it well, the absorbance was measured at a wavelength of 267mn according to UV-Vis spectrophotometry (General rule 0401); Another precision weighing Nefopam hydrochloride control, the same method operation. It is obtained by calculation.
category
Same as Nefopam hydrochloride.
specification
(l) lml:20mg (2)2ml:20mg (3)2ml:lOOmg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:06:04
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CAS: 23327-57-3
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CAS: 23327-57-3
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Mobile: 0086 189 4982 3763
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Product List: View Catalog
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CAS: 23327-57-3
Tel: 18301782025
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QQ: 3008007409
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CAS: 23327-57-3
Tel: 18301782025
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