Timolol Impurity D

Timolol Impurity D is a chemical compound that is used in pharmaceutical research and development. It is a potential impurity in timolol maleate drug substance and is considered as an important analyte in the quality control of timolol maleate drug products. Timolol Impurity D is also used as a reference standard to identify and quantify the impurity in the timolol maleate drug substance. Chemically, Timolol Impurity D is also known as (4R,5S)-4,5-Dihydro-1,3-thiazol-2-amine, and has a molecular formula of C3H6N2S. The compound is a colorless to light yellow crystalline powder with a melting point of 114-116°C. The usage of Timolol Impurity D is regulated by various international organizations such as the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These organizations have established guidelines and specifications for the identification, characterization and quantification of Timolol Impurity D in timolol maleate drug products. In conclusion, Timolol Impurity D is an important chemical compound in the pharmaceutical industry that is used for quality control and analysis of timolol maleate drug substance. Its chemical properties and usage are well-regulated by international organizations to ensure the safety and efficacy of pharmaceutical products.