Name | FELODIPINE |
Synonyms | Spendil CGH-869 FELODIPINE ,ethylmethylester ethylmethyl4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedica Ethyl methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate 4-(2,3-dichlorophenyl)-1,4-dihyro-2,6-dimethyl-3,5-pyridinedicarboxylic acid ethyl methyl ester 4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-5-methoxycarbonyl-3-pyridinecarboxylic acid ethyl ester |
CAS | 72509-76-3 86189-69-7 |
EINECS | 620-472-7 |
InChI | InChI=1/C18H19Cl2NO4/c1-5-25-18(23)14-10(3)21-9(2)13(17(22)24-4)15(14)11-7-6-8-12(19)16(11)20/h6-8,15,21H,5H2,1-4H3 |
InChIKey | RZTAMFZIAATZDJ-UHFFFAOYSA-N |
Molecular Formula | C18H19Cl2NO4 |
Molar Mass | 384.25 |
Density | 1.3506 (rough estimate) |
Melting Point | 142-145°C |
Boling Point | 471.5±45.0 °C(Predicted) |
Flash Point | 239°C |
Water Solubility | insoluble |
Solubility | DMSO: soluble28 mg/mL H2O: insoluble |
Vapor Presure | 4.62E-09mmHg at 25°C |
Appearance | White or yellowish crystalline powder |
Color | light yellow |
pKa | 2.73±0.70(Predicted) |
Storage Condition | 2-8°C |
Stability | Stable for 1 year from date of purchase as supplied. Solutions in DMSO or ethanol may be stored at -20° for up to 3 months. |
Refractive Index | 1.6500 (estimate) |
MDL | MFCD00868316 |
Physical and Chemical Properties | Melting point 142-145°C water-soluble insoluble |
Use | For the treatment of hypertension, ischemic heart disease, heart failure and other diseases |
Hazard Symbols | Xn - Harmful |
Risk Codes | 22 - Harmful if swallowed |
Safety Description | 36 - Wear suitable protective clothing. |
UN IDs | UN 3077 9 / PGIII |
WGK Germany | 3 |
RTECS | US7968700 |
HS Code | 29333990 |
This product is (±)-2, 6-dimethyl-4-(2, 3-dichlorophenyl)-l, 4-dihydro-3, methyl Ethyl 5-pyridinedicarboxylate. Calculated as dried product, the content of C18H19C12N04 shall not be less than 99.0%.
The melting point of this product (General 0612) is 141~145°C.
take this product l. After being dissolved by adding 20ml of methanol, the solution shall be clear and colorless; If the color is colored, it shall be checked according to law (General rule 0901 second method), and the absorbance shall be measured at the wavelength of 440nm, and shall not exceed 0.10.
take 2.0g of this product, add 50ml of water, boil, immediately cool, add water to make up 50ml, filter, take 25ml of filtrate, check according to law (General rule 0801), not more concentrated (0.005%) than the control solution made from of standard sodium chloride solution.
operation in the dark. Take this product, precision weighing, add methanol to dissolve and quantitatively dilute to make a solution containing about 1 mg per 1 ml, as a test solution; Take another 2, 6-dimethyl-4-(2,3-dichlorophenyl)-3, 5-pyridinedicarboxylic acid methyl ester (impurity I ), Precision weighing, plus methanol dissolved and quantitative dilution made in each 1 ml containing about 0.1 mg of the solution, take 1 ml accurately, put it in a 100ml measuring flask, add 1 ml of the test solution accurately, dilute to the scale with the mobile phase, shake well, and use as a control solution. According to high performance liquid chromatography (General 0512) test. Silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-acetonitrile-water (50:15:35) was used as the mobile phase; The detection wavelength was 238nm. Take appropriate amount of Felodipine and impurity I control, add methanol to dissolve and dilute to make mixed solution containing about 1 mg and 10ug respectively per 1 ml, take 10 u1, inject human liquid chromatograph, the degree of separation of the impurity I peak from the Felodipine peak should be greater than 3.0. The LOLs of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and shall not exceed 0.1%; the Peak area of other individual impurities shall not be greater than 0.5 times (0.5%) The Peak area of Felodipine in the control solution; The total amount of impurities shall not exceed 1.0%.
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
take 1.0g of this product and check it according to law (General rule 0841). The remaining residue 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 l.Og, add lg mixed with calcium hydroxide, add a small amount of water, stir evenly, first heat with small fire, then burn to complete Ash, gray-white, cool, the residue shall be dissolved by adding 8ml of hydrochloric acid and 20ml of water, and shall be checked according to law (General Principles 0822, first law), and shall comply with the regulations (0.0002%).
take this product 0.3g, precision weighing, add glacial acetic acid 40ml dissolved, add dilute sulfuric acid 20ml and O-Phenanthroline indicator solution 2 drops, with cerium sulfate titration solution (O. 1 mol/L) titration to Orange disappeared, and the titration results were corrected with a blank test. Each 1 ml of the cerium sulfate titration solution (0.1 mol/L) corresponds to 19.21mg of C18H19Cl2NO4.
calcium channel blockers.
light shielding, sealed storage.