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-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 is designed for high sensitivity and easy maintenance. The optimised internal structure including the newly developed collision cell enables analysis at ppt level sensitivity; depending on the elements even sub-ppt levels can be reached. This outstanding sensitivity is achieved by minimised 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 ionised atoms go through can be easily removed for maintenance so that stable analysis for longer period can be ensured.

Using the ‘Development Assistant’ function, users can now simply perform qualitative analysis by selecting the elements to be measured. The software then automatically sets the suitable analysis conditions. When performing routine analysis, the ‘Diagnosis Assistant’ automatically checks if there is spectral interference and indicates problems if there are any. Shimadzu’s FDA 21 CFR Part 11 compliant LabSolutions software provides ensured analytical data management.

Shimadzu’s unique mini-torch plasma unit significantly reduces the consump­tion of argon gas. The Eco mode automatically reduces the argon gas flow during standby.

Web link: www.shimadzu.eu/icpms-2030