General Information

Felodipine Impurities and Felodipine

Daicel Pharma specializes in synthesizing impurities for Felodipine, an active pharmaceutical ingredient. We offer crucial impurities such as Dehydro Felodipine, Felodipine 3,5-Dimethyl Ester, Felodipine EP Impurity C, and Methyl 2-(2,3-dichlorobenzylidene)-3-oxobutanoate, which play a vital role in evaluating the purity, and safety of Felodipine. Daicel Pharma also provides custom synthesis of Felodipine impurities to meet specific client needs, and we offer worldwide delivery options.

Felodipine [CAS: 72509-76-3], a calcium channel-blocking agent of the dihydropyridine class, reduces the contractility of the heart and lowers blood pressure. Felodipine finds application in managing hypertension and angina pectoris. Its therapeutic effects encompass calcium channel blockade, antihypertensive properties, vasodilation, and anti-arrhythmic effects.

Felodipine: Use and Commercial Availability  

Felodipine, an FDA-approved medication for hypertension, belongs to the dihydropyridine class of calcium channel blockers. It effectively reduces blood pressure and decreases the risks associated with cardiovascular morbidity and mortality. Moreover, Felodipine ER is useful as an adjunctive therapy for individuals with severe hypertension that remains uncontrolled despite treatment with beta-blockers and diuretics. The drug is available under Plendil.

Felodipine Structure and Mechanism of Action

The chemical name of Felodipine is 3-Ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate. Its chemical formula is C₁₈H₁₉Cl₂NO_4, and its molecular weight is approximately 384.2 g/mol.

Felodipine prevents voltage-dependent calcium currents in vascular smooth muscle and myocardial cells. It causes dilation of the main coronary and systemic arteries, thus lowering blood pressure.

Felodipine Impurities and Synthesis

Felodipine impurities are unintended substances that may be present in Felodipine. They can arise during the manufacturing process¹ or storage may affect the drug’s quality, efficacy, and safety. The formation of impurities in Felodipine can result from degradation, interaction with excipients or packaging materials, or impurities in raw materials. Analytical methods such as chromatography and spectroscopy help detect and quantify these impurities. Stringent control measures are implemented during the manufacturing process to minimize impurity formation and ensure the quality of Felodipine.

Daicel Pharma, in adherence to cGMP standards, operates an analytical facility where we prepare Felodipine impurity standards like Dehydro Felodipine, Felodipine 3,5-Dimethyl Ester, Felodipine EP Impurity C, and Methyl 2-(2, 3-dichlorobenzylidene)-3-oxobutanoate. We offer a comprehensive Certificate of Analysis (CoA) for these impurities, providing a detailed characterization report. The CoA includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis. Upon request, we give additional data like 13C-DEPT. We can synthesize unknown Felodipine impurities or degradation products. Each delivery has a comprehensive characterization report.