Agilent Technologies announced OpenLAB Data Store for MS, a 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 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). OpenLAB Data Store for MS is part of a suite of software products designed to integrate and manage scientific information throughout its lifecycle, across the laboratory and the enterprise. It complements Agilent’s OpenLAB Enterprise Content Manager software for the compliant management of multi-vendor, multi-instrument data in larger laboratories. OpenLAB Enterprise Content Manager is fully scalable to a worldwide deployment.
Agilent Technologies Inc., 800–227–9770, www.agilent.com