Effective Analysis of Elemental Impurities in Pharmaceuticals Using EDX Fluorescence Spectrometry Release of the Pharmaceuticals Impurities Analysis Method Package

Analysis with the EDX-7000 can be started by putting the sample in the special container and placing it in the instrument. There is no need to chemically pretreat the sample. Special gases and vacuum conditions are unnecessary, and since it operates on household power supply, installation is easy. In addition, by incorporating two kinds of optimized analysis methods in the pharmaceuticals impurities analysis method package, a total of 12 elements*, seven identified as Class 1 and Class 2A, and five from Class 2B as stipulated by the ICH Q3D, can be analyzed effectively. This is also effective for cross checks with other instruments, such as ICP-AES.
*: The elements are cadmium, lead, arsenic, mercury, cobalt, vanadium, nickel, palladium, iridium, rhodium, ruthenium, and platinum.