Ketoconazole Impurity E

Ketoconazole Impurity E is a byproduct that can occur during the synthesis of Ketoconazole, a commonly used antifungal medication. This impurity, also known as 1-Acetyl-4-cyclohexylpiperazine, is a cyclic tertiary amine with a molecular formula of C12H20N2O. It is classified as a heterocyclic compound due to the presence of a nitrogen atom in the piperazine ring. While Ketoconazole Impurity E is not intended for use in pharmaceutical products, it is important to monitor its levels in Ketoconazole formulations to ensure product quality and safety. Excessive levels of impurities can impact the stability and efficacy of the drug, leading to potential adverse effects in patients. Chemically, Ketoconazole Impurity E is a relatively stable compound with a melting point of 72-76°C. It is soluble in organic solvents such as methanol, ethanol, and chloroform, but insoluble in water. It is also sensitive to light and should be stored in a cool, dry place away from direct sunlight. In summary, Ketoconazole Impurity E is a byproduct of the synthesis of Ketoconazole that can impact the quality and safety of pharmaceutical products. Its chemical properties and solubility characteristics make it important to monitor its levels in drug formulations to ensure product efficacy and safety.