Furosemide Impurity 14 (N-Nitroso-Furosemide)

Furosemide Impurity 14, also known as N-Nitroso-Furosemide, is a chemical compound that is often used as an impurity reference standard in the pharmaceutical industry. This compound is a derivative of Furosemide, which is a well-known diuretic used in the treatment of high blood pressure, fluid retention, and other medical conditions. N-Nitroso-Furosemide is a nitrosamine, which means it contains a nitroso group (-NO) attached to a secondary amine. This compound is formed when Furosemide is exposed to nitrous acid, which can occur during the manufacturing process or under certain storage conditions. The formation of N-Nitroso-Furosemide can be a concern for pharmaceutical manufacturers because nitrosamines are known to be potential carcinogens. To ensure the safety and efficacy of Furosemide products, regulatory agencies such as the FDA and EMA have established limits on the levels of N-Nitroso-Furosemide allowed in pharmaceuticals. The use of N-Nitroso-Furosemide as a reference standard allows manufacturers to accurately detect and quantify the impurity in their products, ensuring compliance with regulatory requirements. In summary, N-Nitroso-Furosemide is an impurity reference standard that plays an important role in the quality control of Furosemide products. Its chemical properties and potential health risks make it a critical component of the pharmaceutical industry's quality assurance processes.