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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 spectrometry (ICP-MS).

We provide robust, proven workflows and instrumentation for determining elemental impurities in drugs.

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Elemental impurities workflow

elemental impurities workflow

Elemental impurities products for all budgets
Sensitive, high-throughput, compliant ICP-MS

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.

Cost-effective, simple, compliant AA

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.


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