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).
“Target ICP-MS labs need a networked solution for U.S. FDA 21 CFR Part 11 and EU Annex 11 compliant data storage that’s affordable and easy to use,” said Bruce von Herrmann, vice president and general manager of Agilent’s Software and Informatics Business. “In combination with an overall laboratory compliance plan, an ICP-MS MassHunter system with OpenLAB Data Store for MS provides controls needed to follow regulatory guidelines.”
For lab managers who oversee one to 15 ICP-MS MassHunter systems, OpenLAB Data Store for MS offers the following benefits:
• Affordable with cost-effective deployment and administration for a lower total cost of ownership.
• Supports U.S. FDA 21 CFR Part 11 and EU Annex 11 compliance for USP <232>/<233> with comprehensive data security, audit trails and e-signature authorization.
• Efficient central storage and retrieval of ICP–MS MassHunter data.
• Networked solution with centralized system management boosts productivity.
• Based on industry-standard technology.
OpenLAB Data Store for MS is part of an industry-leading 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.