Diltiazem Impurity 1

Diltiazem Impurity 1 is an impurity or a byproduct of the synthesis of the calcium channel blocker drug, diltiazem. It is also known as N-(2,6-dimethylphenyl)-3-(dimethylamino)propyl-4-(3,4,5-trimethoxyphenyl)pyrrole-2-carboxamide. This impurity is typically found in small quantities in diltiazem formulations and is considered to be a minor impurity. As an impurity, Diltiazem Impurity 1 has no therapeutic benefit and can potentially affect the purity, potency, and quality of the drug product. Therefore, regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have set limits on the amount of impurities allowed in drug products. In terms of chemical information, Diltiazem Impurity 1 is a pyrrole derivative with a molecular weight of 472.6 g/mol. It is a white to off-white solid that is soluble in organic solvents such as methanol, ethanol, and dimethyl sulfoxide (DMSO). In summary, Diltiazem Impurity 1 is an unwanted byproduct of the synthesis of diltiazem that can potentially affect the quality of the drug product. It is important to monitor and control the levels of impurities in drug products to ensure their safety and efficacy.