Molecular Formula | C14H21ClN2O3 |
Molar Mass | 300.78 |
Melting Point | 228° |
Boling Point | 434.5°C at 760 mmHg |
Flash Point | 216.6°C |
Solubility | Freely soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in |
Vapor Presure | 9.46E-08mmHg at 25°C |
Appearance | Solid |
Color | White to Off-White |
Storage Condition | under inert gas (nitrogen or Argon) at 2-8°C |
MDL | MFCD00941392 |
This product is 4-acetamidophenyl 2-(N,N-diethylamino) acetate hydrochloride. The content of C14H20N203 • HC1 shall be between 98.0% and 102.0% calculated as dry.
take l.Og of this product, Add 10ml of water to dissolve, and measure it according to law (General rule 0631). The pH value should be 2.5~4.5.
take 1.75g of this product and add 10ml of water to make the dissolved solution clear and colorless; If the color is colored, measure by UV-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 390nm and should not exceed 0.05.
new system for clinical use. Take 2.0g of this product, precision weighing, Precision Add acetonitrile 10ml, shake for 10 minutes, filter, precision take the filtrate 2ml, put the 10ml measuring flask, with sodium octane sulfonate solution (take sodium octane sulfonate 2.16g, add water to dissolve and dilute to 1000ml, adjust the pH value to 3.0 with glacial acetic acid, dilute to the scale, shake well, as a test solution; Take lml accurately and put it in a 100ml measuring flask, dilute to scale with mobile phase, shake well, take 1ml with precision, put it in 10ml measuring flask, dilute to scale with mobile phase, shake well, and use as control solution; in addition, appropriate amounts of the p-aminophenol control and the acetaminophen control were carefully weighed, dissolved and quantitatively diluted with acetonitrile to make about O-aminophenol per 1ml. 1ml of a mixed solution of 1 mg and 0.8mg of acetaminophen was accurately measured, placed in a 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to serve as a reference solution. According to the test of high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as filler; Sodium octane sulfonate solution (octane sulfonate
Sodium 2.16g, dissolved in water and diluted to 3.0 ML, adjusted to pH with glacial acetic acid)-acetonitrile (70:30) as mobile phase; Detection wavelength 246mn. The reference solution was injected into the human liquid chromatograph, and the Order of the peaks was acetaminophen and p-aminophenol. The separation degree of the p-aminophenol peak, the acetaminophen peak and the adjacent impurity peak should meet the requirements. The test solution, the control solution and the reference solution were respectively injected with 20 u1, and the chromatogram was recorded to 2 times of the retention time of the p-aminophenol peak. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of p-aminophenol shall not exceed 0.0025% and the content of acetaminophen shall not exceed 0.02%, the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.1% ) , and the sum of the peak areas of other impurities shall not be greater than 2 times the main peak area of the control solution (0.2% ) . The chromatogram of the test solution is 0.01 times smaller than the main peak area of the control solution.
take about 0.5g of this product, precision weighing, top empty bottle, precision add water 5ml to dissolve, seal, as a test solution; Another methanol, ethanol, the appropriate amount of acetone and methane was accurately weighed and quantitatively diluted with water to make a mixed solution containing 0.3mg of methanol, 0.5mg of ethanol, 0.5mg of acetone and 60ug of dichloromethane respectively per 1 ml, 5ml was accurately measured, placed in a top empty bottle, sealed, and used as a reference solution. According to the test for determination of residual solvents (General rule 0861, second method), a capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polar) as stationary liquid; The starting temperature is 50°C, maintain 7 minutes, at a rate of 25°C per minute to 200°C, maintain 5 minutes; Injection port temperature is 150°C; Detector temperature is 250°C; Headspace bottle equilibrium temperature is 80°C, the equilibration time was 30 minutes. Take the headspace injection of the reference solution, and the separation degree of each component peak shall meet the requirements. Then take the sample solution and the reference solution respectively, and record the chromatogram. According to the external standard method to calculate the peak area, methanol, ethanol, acetone and two gas methane residues should be in accordance with the provisions.
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
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).
take this product and use the bacterial endotoxin test water to make a solution containing 1.65mg of propiathimol hydrochloride per 1 ml, and check according to law (General rule 1143), the amount of endotoxin should be less than 0.050EU per 1 mg of propafetamo hydrochloride. (For injection)
take this product, add Sterile Water for Injection to make a solution containing g per lml, check according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
take 0.25g precision weighing of this product, add 25ml of glacial acetic acid and acetic anhydride to dissolve, according to the potentiometric titration method (General rule 0701), with high gas acid titration solution (O. 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 30.08mg of c14h20n203.hc1.
antipyretic analgesic, non-steroidal anti-inflammatory drugs.
sealed and stored in a cool and dry place.