Singapore: The new ICPMS-2030 from Shimadzu is designed to respond to the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Q3D guidelines for elemental impurities in pharmaceutical products.
The ICH Q3D specifies allowable limits of daily intake of 24 elements of toxicological concern, and requires high sensitive and high precision measurement of such elements. The ICPMS-2030 satisfies these requirements with ppt level high sensitivity, which is achieved by newly developed collision cell and optimized internal structure, offering FDA 21 CFR Part 11 compliance, automated analytical method development function, and unique measurement result evaluation function to provide analytical results with exceptionally high reliability.
US pharmacopoeia indicates limits of elemental impurities (USP < 232>) and detection technique by ICP-MS (USP < 233>), which will be in effect in January 2018. In USP < 735>, X-ray Fluorescence Spectrometry is adopted as general analytical method. For those demands, Shimadzu offers total solution for elemental impurities analysis from screening without sample preparation by the EDX-7000/8000, FDA 21 CFR Part 11 compliant Energy Dispersive X-ray Fluorescence Spectrometers, to high-sensitive and precision analysis by the ICPMS-2030.
The ICPMS-2030 will be exhibited at PITTCON 2016 from March 6th to 10th in Atlanta, GA, USA.
Designed for High Sensitivity and Easy Maintenance
The optimized internal structure including the newly-developed collision cell enables analysis at sub-ppt level sensitivity by minimized spectral interference and improved transmission efficiency of atomic ions, so that precise quantitation results in elemental impurity analysis become more reliable. The sample injection unit and interface unit where ionized atoms go through can be easily removed for maintenance so that stable analysis for longer period can be ensured.