Expanding Solutions for Elemental Impurity Analysis in Pharmaceutical Products

Shimadzu has released its ICPMS-2030 Inductively Coupled Plasma Mass Spectrometer. The new ICPMS-2030 is designed to meet the requirements of the ICH (International Council for Harmonisation of Technical Requirements for 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 highly sensitive and high-precision measurement of such elements.

The ICPMS-2030 satisfies these requirements with ppt level high sensitivity. This is achieved by the newly developed collision cell and the optimised 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.

The US pharmacopoeia indicates limits of elemental impurities (USP<232>) and detection techniques using 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 using the EDX-7000/8000, FDA 21 CFR Part 11 compliant Energy Dispersive X-ray Fluorescence Spectrometers, to highly sensitive and high-precision analysis using the ICPMS-2030.

The ICPMS-2030 combines benefits covering performance features such as sensitivity and reliability, as well as operational, handling and economic aspects.