Levosimendan Cyanoacetate Hydrazone Impurity

Levosimendan Cyanoacetate Hydrazone Impurity is a chemical impurity that is often found in pharmaceutical preparations containing the active ingredient levosimendan. Levosimendan is a calcium sensitizer and potassium channel opener used in the treatment of heart failure. Levosimendan Cyanoacetate Hydrazone Impurity is a byproduct of the synthesis of levosimendan and is not intentionally added to pharmaceutical preparations. However, its presence can affect the efficacy and safety of the medication. Therefore, it is important to monitor and control the level of this impurity in pharmaceutical products. Chemically, Levosimendan Cyanoacetate Hydrazone Impurity is a hydrazone derivative of cyanoacetic acid. It is a colorless to pale yellow solid with a melting point of 103-105°C. It is soluble in organic solvents such as methanol, ethanol, and acetonitrile but insoluble in water. The usage of Levosimendan Cyanoacetate Hydrazone Impurity is limited to its detection and quantification in pharmaceutical preparations containing levosimendan. Analytical methods such as high-performance liquid chromatography (HPLC) and gas chromatography (GC) are commonly used to detect and quantify this impurity. The acceptable limit for Levosimendan Cyanoacetate Hydrazone Impurity in pharmaceutical preparations is 0.1% or less.