Development and application of chemical reference materials

Chemical reference material (CRM) is an important material basis in the process of chemical drug research and development and quality control. This paper introduces the definition and classification of CRMs; the domestic and international regulations and guidelines for the research and development, production, management and use of CRMs by pharmaceutical companies and authoritative CRM issuing organizations; the common preparation methods and key technologies of CRM raw materials; and the technical requirements for the selection of raw materials for different types of CRMs. In addition, this paper also introduces the routine development process and data requirements for the candidate raw material to become a CRM after chemical structure verification, physical and chemical property analysis, homogeneity assessment, stability monitoring, and assignment. It also introduces the classical assignment method, mass balance method, in detail, to provide users of CRMs and the developers of new drugs with some technical references related to the development, application and management of CRMs in China.