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.
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 Thermo Scientific iCAP RQplus 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.
Qualified Thermo Scientific iCAP PRO XP ICP-OES comply with current and future legislation, including the General Chapters and a Supplemental General Chapter of the United States Pharmacopeia:
- <232> Elemental Impurities – Limits
- <233> Elemental Impurities – Procedure
- <2232> Elemental Contaminants in Dietary Supplements.
Qtegra ISDS Software provides full traceability of results and workflow. It incorporates features to support compliance with CFR 21 Part 11, including electronic signatures and audit trails. Dedicated validation solutions ensure fast instrument commissioning in the laboratory
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.
Get access to the latest video seminars, webinars primers, documentation, and calculation tools for pharmaceutical elemental impurities all in one place on our USP 232 Toolkit page. Learn from industry experts, consultants and USP alumni on the latest regulations and workflows.
