USA: Agilent Technologies Inc. announced the OpenLAB Data Store for MS, a simple and affordable networked solution for compliant storage of mass spectral data acquired with Agilent’s ICP-MS MassHunter system.
The software is designed for medium to small laboratories measuring inorganic impurities in pharmaceutical products and ingredients in accordance with upcoming specifications from the United States Pharmacopoeia.
The OpenLAB Data Store for MS bundle allows customers to grow their compliant data storage to a second ICP-MS system at a lower price than standalone workstation solutions.
The United States Pharmacopoeia has proposed two new general chapters to test for inorganic impurities in pharmaceutical products and ingredients: Elemental Impurities—Limits <232> and Elemental Impurities—Procedures <233>. Effective May 2014, the new chapters specify maximum daily dose limits for 15 elements.
These elemental impurities are most efficiently measured using ICP-MS because of its low detection limits, dynamic range and throughput. Electronic management of the ICP-MS data is required as defined in Part 11 of the U.S. Food and Drug Administration’s Code of Federal Regulations (21 CFR Part 11) and the European equivalent (EU Annex 11).
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