Nicorandil is N-(2-hydroxyethyl)-nicotinamide nitrate (ester). It is a white crystalline powder or white needles with a faint, characteristic odour. It is freely soluble in methan ol, ethanol, aceto ne or glacial acetic acid, slightly soluble in chloro form or water, almost insoluble in ether or benzene. Melting point 88.5-93.5 ºC. Acute toxicity LD50 rat (mg/kg): 1200-1300 orally, 800-1000 intravenously.Nicorandil is a nitric oxid e donor and ATP-sensitive potassium channel opener. A study showed that Nicorandil is able to protect against stress-induced cell death in dystrophin-deficient cardiomyocytes and also preserve cardiac function in the mdx mouse heart subjected to ischemia and reperfusion injury.
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Items | Standard | Proventus |
APPEARANCE | Off white to white powder | Pulvis albus |
IDENTIFICATION | A: IR B: Retention time |
Obsequitur Obsequitur |
WATER | ≤0.5% | 0.06% |
HEAVY METALS | ≤0.002% | Obsequitur |
ISOMERS | SFBD1≤0.15% | Undetected |
SFBD2≤0.15% | Undetected | |
SFBE≤0.15% | Undetected | |
RELATED SUBSTANCES | SFBA-1≤0.15% | 0.04% |
SFBMA≤0.15% | Undetected | |
CHLORO-SFB≤0.15% | 0.05% | |
DiSFBMA-SFB≤0.15% | 0.02% | |
Methyl-SFB≤0.15% | Undetected | |
Pentafluoro-phenol≤0.15% | Undetected | |
Amino-SFB≤0.15% | Undetected | |
Any unknown impurity≤0.1% | 0.04% | |
Total impurity≤1.0% | 0.21% | |
RESIDUE SOLBENTS | Methanol≤3000ppm | Undetected |
Isopropyl alcohol≤5000ppm | 19ppm | |
Dichloromethane≤600ppm | Undetected | |
Tetrahydrofuran≤720ppm | Undetected | |
Acetic acid≤5000ppm | Undetected | |
Toluene≤890ppm | Undetected | |
Chlorobenzene≤360ppm | Undetected | |
Methyl tert-butyl ether≤5000ppm | 103ppm | |
ASSAY | ≥99.0% | 99.8% |
RESULT: It complies to prescribed enterprise standard |
Nicorandil is N-(2-hydroxyethyl)-nicotinamide nitrate (ester). It is a white crystalline powder or white needles with a faint, characteristic odour. It is freely soluble in methan ol, ethanol, aceto ne or glacial acetic acid, slightly soluble in chloro form or water, almost insoluble in ether or benzene. Melting point 88.5-93.5 ºC. Acute toxicity LD50 rat (mg/kg): 1200-1300 orally, 800-1000 intravenously.
Nicorandil is used for the prevention and treatment of chronic stable angina. It is usually used when angina becomes difficult to control by other drugs and is given as an additional treatment.
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