Genotoxicity - Impurity Studies

Heterogeneous mass spectrometry refers to the type and content of various impurities in a drug. Based on the physiological activity of each impurity in the drug, setting quality control limits one by one is the key to ensuring drug safety and is also the core issue of drug heterogeneous mass spectrometry control. The basic strategy for implementing heterogeneous mass spectrometry control proposed in 2010 summarized the key technical issues related to heterogeneous mass spectrometry control as: separation and analysis of complex system samples There are three aspects: structural analysis of trace components and toxicity evaluation of trace components. The pharmaceutical technology team has rich experience in synthesis and analysis, and has developed impurity control strategies based on impurity mass spectrometry research and process routes. Through various analytical methods, impurities that may actually exist are studied; Scientifically infer possible impurities based on the synthesis process route. The separation and identification of impurities is a very important part of drug quality research. When studying the structure of unknown organic impurities, it is often necessary to enrich the impurities through liquid phase preparation and analyze them. The synthesis and characterization of impurities are very important steps in the process of impurity research. Microspectral medicine can provide a series of services from separation and purification to impurity analysis, impurity synthesis, impurity structure confirmation, and standardization for impurities