Linagliptin Impurity 49

Linagliptin Impurity 49 is a chemical compound that is commonly used in the pharmaceutical industry as a reference standard during the development and manufacturing of linagliptin-based drugs. It is also used as an analytical tool to detect and quantify impurities and other related substances in linagliptin drug substances and drug products. Chemically, Linagliptin Impurity 49 is a derivative of pyrazole, which is a five-membered heterocyclic compound containing two nitrogen atoms in the ring. It is a white to off-white powder with a molecular weight of 222.23 g/mol. The usage of Linagliptin Impurity 49 is strictly regulated and controlled under the guidelines of various regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These guidelines ensure the quality, safety, and efficacy of the final linagliptin product. Linagliptin Impurity 49 is typically used in small quantities (parts per million) during the development, validation, and routine analysis of linagliptin drug substances and drug products. Its presence in the final product is closely monitored to ensure compliance with regulatory standards and to ensure the product's safety and efficacy. In conclusion, Linagliptin Impurity 49 is an essential reference standard used in the pharmaceutical industry for the development, validation, and analysis of linagliptin-based drugs. Its usage is strictly regulated to ensure the quality, safety, and efficacy of the final product.