Brexpiprazole Impurity 15

Brexpiprazole Impurity 15 is a chemical compound that is commonly used in the pharmaceutical industry as an impurity in the production of the antipsychotic drug, Brexpiprazole. It is also known by its chemical name, 2-(2,3-dichlorophenyl)-3-methyl-1,2,4-oxadiazole-5-carboxylic acid. This impurity is formed during the synthesis of Brexpiprazole and can be present in small amounts in the final product. Brexpiprazole Impurity 15 is characterized by its chemical structure, which consists of a benzene ring with two chlorine atoms and a five-membered ring containing nitrogen and oxygen atoms. It is a white to light yellow crystalline powder with a melting point of 196-198°C. It is insoluble in water but soluble in organic solvents like methanol, ethanol and acetonitrile. Brexpiprazole Impurity 15 is considered a potential impurity due to its potential to affect the quality, safety and efficacy of the final drug product. As a result, it is important to monitor and control its levels during the manufacturing process. Regulatory agencies like the FDA and the EMA have established limits for its presence in the final drug product. In summary, Brexpiprazole Impurity 15 is a chemical compound that is used in the pharmaceutical industry as an impurity in the production of Brexpiprazole. It is important to monitor and control its levels during the manufacturing process to ensure the quality, safety and efficacy of the final drug product.