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
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