Specpure® ICH/USP Standards
Specpure® ICH/USP Standards
Specpure® elemental impurity standards are the products of choice for elemental analysis of active pharmaceutical ingredients and excipients. Specpure® elemental impurity standards cover all the regulated elements required by USP <232> and ICH Q3D and are traceable to NIST SRMs, providing the utmost confidence in certified concentrations. Our stock solutions are manufactured from high purity starting materials, acids, and 18 MOhm deionized water in the proper concentrations for various routes of exposure (oral and parenteral) based on determined permissible daily exposure limits. We offer seven solutions covering oral and parenteral administration routes, including an internal standard solution and a kit, which allows selective analysis of certain element classes as needed. Specpure® elemental impurity standards provide the quality of certified reference material needed to generate reliable and accurate data and limits chemical compatibility and stability issues encountered when preparing working standards from single element solutions.
