Kaisai Impurity Research Project Team Officially Established
In the context of generic drug consistency evaluations, especially with the rollout of consistency evaluations for injections, impurity research has become an indispensable part of drug development. How to conduct impurity research in a scientific, rational, and appropriate manner has become a focal point of attention for industry professionals. Impurity research is an important ongoing aspect throughout drug development. Through impurity profiling analysis, a comprehensive overview of impurities in the product (including types, contents, sources, and structures) can be obtained. Impurity control based on impurity profiling is a specific practice of the QbD (Quality by Design) basic concept in impurity research and control.
Under the strategic guidance of the company's leadership, after more than half a year of preparation, the Kaisai Impurity Research Project Team has been officially established and is now accepting external business related to drug impurities. Based on the latest ICH guidelines and relevant guidelines issued by countries such as China, the United States, Japan, and Europe, we classify impurities into organic impurities (process impurities, degradation impurities, and isomer impurities), inorganic impurities (residual solvents, elemental impurities), genotoxic impurities, and polymorph impurities. The company is equipped with LC-MS, GC-MS, ICP, IR, UHPLC, Pre-HPLC, freeze dryers, and other equipment, complemented by NMR and XRD from partner units. With a gradually improving quality control system, the Impurity Research Project Team is continuously enhancing its capabilities. Currently, the projects we have completed and reserved include voglibose, vildagliptin, linagliptin, betaxolol, metoprolol, benidipine, nilvadipine, ambroxol, bromhexine, clemastine, and others. We welcome interested friends to exchange and consult.
Our Services:
A. Custom Synthesis of Impurities Evaluate potential process impurities in different synthetic routes for APIs and custom synthesize a series of such impurities; Evaluate potential degradation impurities for different functional groups in APIs and custom synthesize such impurities.
B. Separation, Purification, and Lyophilization of Impurities For impurities with low content or those difficult to synthesize, use preparative liquid chromatography separation technology to prepare such impurities.
C. Detection Services for Metal Impurities, Ionic Impurities, and Gaseous Impurities
D. Assessment, Preparation, and Validation of Genotoxic Impurities/Potential Genotoxic Impurities
E. Research on Polymorph Impurities
F. Structural Confirmation of Impurities (LC-MS, GC-MS, 1H-NMR, 13C-NMR, IR, XRD) In collaboration with partner units, provide structural analysis of impurities, including liquid phase spectra, primary and secondary mass spectra, NMR proton spectra, carbon spectra, infrared spectra, and interpretation of various spectra.
Through the above methods, we provide risk assessments and solutions for impurities in the quality research process of APIs, determine whether secondary development of API synthesis processes is needed, and offer technical support and services for the domestic and international registration of APIs.
