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Metals standards for the pharmaceutical industry

Date:15 February 2013

Regulatory requirements for inorganic impurities are being tightened. Although changes to the USP-NF General Chapter <232> ?Elemental Impurities ? Limits? and <233> ?Elemental Impurities ? Procedures? have been delayed, the proposed changes highlight a valid concern that the analytical techniques in place are inadequate for the analysis of inorganic impurities in drug substances and products in the modern world. The former tests in General Chapter <231> are based on an unspecific sulfide precipitation and will be replaced by instrumental analytical methods like ICP-OES and ICP-MS. Limits will be given not only for the single metals, but will also take into account the different speciations of certain elements.

LGC Standards provides a range of reference materials for metals residues analysis in order to help you prepare for the upcoming regulatory requirements, and will facilitate greater analytical certainty. All products are prepared from high purity raw materials, acids and 18 Mohm Di water, assayed by NIST HP-ICP-AES method, and purity is confirmed by ICP-MS. Furthermore, they are manufactured under ISO 9001 and ISO Guide 34, certified under ISO/IEC 17025 and accompanied by a NIST-traceable COA.

For further information on our metals standards please click here.

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