Irbesartan Impurity 15

Irbesartan Impurity 15 is a chemical compound that is used in the pharmaceutical industry as a reference standard for the analysis and characterization of Irbesartan, which is a medication used to treat high blood pressure. This impurity is a byproduct of the synthesis of Irbesartan and is typically present in small amounts in the final drug product. Irbesartan Impurity 15 is also known as 2-n-Butyl-1,3-diazaspiro[4.4]non-1-en-4-one and has a molecular formula of C12H20N2O. It is a white to off-white powder that is sparingly soluble in water and ethanol. This impurity is considered to be a potential genotoxic impurity and is subject to strict regulatory guidelines in the pharmaceutical industry. To ensure the safety and efficacy of Irbesartan, it is essential to monitor and control the levels of Irbesartan Impurity 15 in the final drug product. This is achieved through the use of analytical techniques such as high-performance liquid chromatography (HPLC) and gas chromatography (GC). By measuring the levels of this impurity, pharmaceutical manufacturers can ensure that Irbesartan meets the required quality standards and is safe for human consumption. In conclusion, Irbesartan Impurity 15 plays a critical role in the analysis and control of Irbesartan drug products. Its chemical properties and potential genotoxicity make it a critical impurity to monitor and control in the pharmaceutical industry.