Lercanidipine Impurities

General Information

Lercanidipine Impurities and Lercanidipine 

Daicel Pharma offers worldwide delivery options for custom synthesis of Lercanidipine impurity standards, including crucial impurity standards such as R-Lercanidipine and S-Lercanidipine. These impurity standards play a vital role in evaluating the purity and safety of Lercanidipine, an active pharmaceutical ingredient.

Raynaud’s syndrome, angina pectoris management, and hypertension are the therapeutic uses of Lercanidipine [CAS: 100427-26-7]. It is a diarylmethane compound and belongs to the dihydropyridine class of calcium channel blockers.

Lercanidipine: Use and Commercial Availability

Lercanidipine, available under Zanidip, is a lipophilic dihydropyridine calcium antagonist. It has a long receptor half-life and exhibits a slow onset of action, which helps prevent reflex tachycardia often associated with other dihydropyridines. Lercanidipine provides consistent and sustained blood pressure reduction. It demonstrates comparable antihypertensive efficacy to other agents and can be used as initial monotherapy or combined with other medications.

Lercanidipine Structure and Mechanism of Action

The chemical name of Lercanidipine is 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)- 3-[2-[(3,3-diphenylpropyl)methylamino]-1,1-dimethylethyl] 5-methyl ester 3,5-Pyridinedicarboxylic acid. Its chemical formula is C₃₆H₄₁N₃O_6, and its molecular weight is approximately 611.7 g/mol.

Lercanidipine prevents the entry of extracellular calcium across the vascular smooth muscle cell membranes.

Lercanidipine Impurities and Synthesis

Impurities can form during the manufacturing¹ process of Lercanidipine as byproducts or degradation products. They may arise from the starting materials, reaction conditions, or other factors. Analytical techniques such as high-performance liquid chromatography (HPLC) help detect and quantify these impurities. Stringent control measures ensure that the impurity levels remain within acceptable limits, ensuring the purity and quality of Lercanidipine. Thorough analysis and monitoring help throughout the manufacturing process to maintain the safety and efficacy of the drug.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for preparing Lercanidipine impurity standards. We provide a range of Lercanidipine impurity standards, such as R-Lercanidipine and S-Lercanidipine. Our impurity standards have a detailed Certificate of Analysis (CoA) and a comprehensive characterization report. The CoA encompasses data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Additional data, such as 13C-DEPT, can be provided upon request. We can synthesize unknown Lercanidipine impurity standards or degradation products. Each delivery has a comprehensive characterization report.