Perform compliant USP 232 and ICH Q3D elemental impurities analysis
Elemental impurities in pharmaceutical formulations can interfere with drug efficacy or have a toxic effect on the patient. Regulators have issued guidelines—such as ICH Q3D, USP 232 and USP 233 Elemental Impurities—for monitoring a range of metal elemental impurities in pharmaceutical materials using inductively coupled plasma (ICP), optical emission spectroscopy (ICP-OES), or mass
We provide robust, proven workflows and instrumentation for determining elemental impurities in drugs.
Elemental impurities workflow
Expand your analytical capabilities with this complete trace elemental analysis solution for your high-throughput lab. User-inspired hardware and software combine in the iCAP RQ ICP-MS to deliver maximized productivity and robustness. Simplicity and ease-of-use work in concert to streamline workflows and achieve 'right-the-first-time' results essential to all busy labs.
Enabling regulatory compliance for a wide range of trace element applications, the compact iCAP 7400 ICP-OES delivers superb performance and productivity. The iCAP 7400 ICP-OES comes loaded with the Qtegra Intelligent Scientific Data Solution (ISDS) software, which enables full IQOQ routines, quick set-up and operation.
Offering the best of all AA worlds, the iCE 3500 AAS has a combined flame and furnace system that provides the maximum value for money. To meet pharmaceutical regulations for Class 1 elements we recommend our graphite furnace option; it combines graphite furnace and autosampler. The Thermo Scientific Graphite Furnace and Autosampler accessory offers the benefit of a pre-aligned graphite furnace and intelligent autosampler to simplify analysis and increase productivity. Renowned SOLAAR software provides ease of use and compliance.
As we approach the point at which new USP and ICH methodologies for assessing metal contamination come into effect, companies need to act now or risk being left behind.