The expertise of the EDQM laboratory has recently been confirmed by an ISO 17025 accreditation for Nuclear Magnetic Resonance spectroscopy (NMR) and quantitative Nuclear Magnetic Resonance spectroscopy (qNMR). These modern and state of the art techniques further expand the technical competence of the EDQM laboratory to characterise the official reference standards of the European Pharmacopoeia (Ph. Eur.).
The new accreditation for NMR, awarded by the Belgian Accreditation Body BELAC on 25 October 2018, means that the EDQM laboratory is now in a position to generate ever more accurate and technically valid results for its Ph. Eur. reference standards. Quantitative NMR is an important complement to traditional methods, as it allows a direct assay of the substance concerned.
Dr Susanne Keitel, EDQM Director explained:
“The EDQM laboratory is now one of the few worldwide to be accredited for characterisation through NMR spectroscopy. This consolidates the technical and scientific expertise underpinning the development of the official European Pharmacopoeia reference standards, which are essential for quality control of medicines”.
With the NMR accreditation, the EDQM laboratory is now ISO 17025 accredited for 21 analytical techniques and aligned with the most cutting-edge technologies ensuring maximum quality and accuracy in the characterisation of Ph. Eur. reference standards. These are an essential part of the European Pharmacopoeia, as they complement and underpin documentary texts and are produced specifically for the intended use described in the Pharmacopoeia. The official Ph. Eur. reference standards are established and distributed by the EDQM, which offers an extensive catalogue of over 3,000 reference standards, including chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP), as well as reference spectra for the tests and assays.
- More details on the NMR accreditation is available in the annex to the accreditation certificate on the EDQM website.
- More information on the official Ph. Eur. reference standards.