Fusidic acid EP Impurity J

Fusidic acid EP Impurity J is a chemical compound that is commonly used in the pharmaceutical industry as a reference material. It is a synthetic impurity that is formed during the manufacturing process of fusidic acid, a potent antibiotic agent that is used to treat a range of bacterial infections. The impurity is classified as a byproduct of the reaction between fusidic acid and certain reagents, and it is typically present in small amounts in the final product. Fusidic acid EP Impurity J is mainly used as a reference standard for quality control purposes, as it allows pharmaceutical manufacturers to ensure that their fusidic acid products meet the required purity standards. The impurity is also used as an analytical standard for the development of analytical methods, such as high-performance liquid chromatography (HPLC) and gas chromatography (GC), which are used to identify and quantify the impurity in various samples. From a chemical standpoint, Fusidic acid EP Impurity J is a complex organic compound that contains several functional groups, including carbonyl, hydroxyl, and ether groups. Its molecular formula is C21H22O6, and its molecular weight is 382.4 g/mol. The impurity is a white crystalline solid that is soluble in organic solvents such as methanol and ethanol. Its melting point ranges from 212-216°C, and it has a purity of at least 98%.