Instrument News Agilent Technologies - New Standards for ICH/USP Applications Agilent has introduced a suite of Certified Reference Materials (CRMs) to simplify testing of inorganic contaminants in pharmaceutical products to ICH Q3D and USP<232> requirements. Control of impurities, including elemental contaminants, is critical in pharmaceutical development and production. The current US Pharmacopeia method (USP<231>) does not give adequate information regarding contaminant levels. The new performancebased International Conference on Harmonization (ICH Q3D) and USP methods (USP<232> (limits) and USP<233> (procedures)) address the limitations of the USP<231> method with additional analytes, reduced maximum permitted exposure limits and consideration of the route of exposure. The reference analytical methods are ICP-MS and ICP-OES. Agilent’s ICH/USP<232> impurities kit (pn 5190-9771) includes 5 CRMs with elements sorted by class, chemical compatibility and the relative concentration. These CRMs are manufactured in an ISO Guide 34 facility and certified in an ISO/IEC 17025 testing laboratory. They include a Certificate of Analysis confirming actual concentrations, measurement uncertainty, and NIST traceability. Agilent’s ICP-OES and ICP-MS instrumentation also provides ideal capabilities for determining inorganic contaminants to ICH Q3D and USP<232> requirements. Together with the ICH/USP<232> impurities kit, Agilent offers a complete solution supporting transition to the new methods for elemental impurities in pharmaceuticals. To learn more about Agilent’s ICP-OES and ICP-MS, visit http://www.agilent.com/chem/atomic. P/N Product Name Product Description Matrix Volume 5190-9766 ICH/USP Target Elements Standard A Hg @ 30; As @ 15; Cd, Pb @ 5 μg/ml 2% HNO3 100ml 5190-9767 ICH/USP Target Elements Standard B Ni @ 200; Ag, Se @ 150; V @ 100; TI @ 8; Co @ 50 μg/ml 2% HNO3 100ml 5190-9768 ICH/USP Target Elements Standard C Au, Ir, Os, Pd, Pt, Rh, Ru @ 100 μg/ml 15% HCI 100ml 5190-9769 ICH/USP Target Elements Standard D Cr @ 11,000; Sn @ 6000; Cu, Mo @ 3000; Ba @ 1400; Sb @ 1200; Li @ 550l μg/m 5% HNO3/tr. HF 100ml 5190-9770 Pharma Internal Standard 1 Te @ 25; Sc @ 10; Ge, In, Lu, Bi @ 5 μg/ml 2% HNO3/tr. HF 100ml www.geicp.com Glass Expansion Newsletter | Issue 42 9
GE Newsletter February 2017
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