Primary Reference Standard Range Fills QC Gap
LGC Standards has launched a new range of pharmaceutical primary reference standards. These reference materials are designed to be used in pharmaceutical quality control if no official pharmacopoeia standard exists for a given purpose.
The primary reference standards are of the highest possible purity, fully characterised and satisfy the requirements of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Food and Drug Administration (FDA).
“Our pharmaceutical primary standards are produced under ISO Guide 34 and are accompanied by a comprehensive certificate of analysis,” said Dr. Christian Zeine, Global Product Manager Pharmaceuticals, LGC Standards, who has played a key role in developing the new product range. “The certificate contains comprehensive identity information, including nuclear magnetic resonance spectrum, infrared spectrum and mass spectrometry data,” he explained. Customers will also find detailed assay data on the certificate, which is obtained by qNMR whenever possible, and other accredited techniques. All assays are verified by orthogonal methods such as mass balance.
“Our primary standards fill a gap in the market,” Dr. Zeine stated. “Many of our customers are required to carry out analyses as part of their quality control process, for which no official standards from the pharmacopoeias exist. In these cases, and also in the forensic and clinical environment, our new primary standards will prove ideal.”
LGC Standards has released more than 30 primary reference standards, including paracetamol, itraconazole and several alkylparahydroxybenzoates. “This range is being continually expanded and developed to meet the needs of the industry,” concluded Dr. Zeine.
To receive a brochure detailing the currently available materials, send an email to askus@lgcstandards.com.
LGC Standards, +44 20 8943 8480, uksales@lgcstandards.com,