General Information

Levosimendan Impurities and Levosimendan

For Levosimendan purity and safety of an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Levosimendan impurity standards. These impurity standards include crucial compounds such as Dextrosimendan Impurity and Levosimendan racemate. Additionally, Daicel Pharma provides worldwide delivery options for Levosimendan impurity standards.

Levosimendan [CAS: 141505-33-1], an inotropic agent, treats heart failure. It functions as a vasodilator agent and an antiarrhythmic drug. It acts as an EC 3.1.4.17 inhibitor, a type of 3′,5′-cyclic-nucleotide phosphodiesterase.

Levosimendan: Use and Commercial Availability

Levosimendan, marketed as Simdax, is a calcium sensitizer and potassium channel opener for the short-term treatment of acutely decompensated severe chronic heart failure. It is a vasodilator and cardiac stimulant. Levosimendan also opens vascular smooth muscle cells.

Levosimendan Structure and Mechanism of Action  

The chemical name of Levosimendan is 2-[2-[4-[(4R)-1,4,5,6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl]phenyl]hydrazinylidene]propanedinitrile. Its chemical formula is C₁₄H₁₂N₆O, and its molecular weight is approximately 280.29 g/mol.

Levosimendan sensitizes troponin C to calcium and increases the effects of calcium on cardiac myofilaments.

Levosimendan Impurities and Synthesis  

Levosimendan impurities refer to the undesired substances or byproducts that may be present in Levosimendan formulations. They can arise during the manufacturing process¹ or storage of the drug. The impurities in Levosimendan can impact its purity, quality, and overall effectiveness. Therefore, pharmaceutical manufacturers need to monitor and control the impurity levels in Levosimendan to ensure product safety and efficacy. Stringent quality control measures help minimize impurity levels and maintain the purity of Levosimendan for treating heart failure.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for preparing Levosimendan impurity standards, which include Dextrosimendan Impurity and Levosimendan racemate. Our Levosimendan impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report has data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, additional data like 13C-DEPT can give. Moreover, we can synthesize unknown Levosimendan impurity standards and degradation products. Each delivery has a comprehensive characterization report.