qNMR Meeting Cologne

During the last years, the quantitative NMR (qNMR) developed into an independent discipline. The method finds it way in the European and the United States Pharmacopeia. Especially in the pharmaceutical analytics specific requirements according to GxP Compliance have to be met. Various questions relating to System Suitability Tests, Design Qualification-Installation Qualification-Operation Qualification-Performance Qualification (DQ-IQ-OQ-PQ), Round Robin Tests and adequate method validation are still unanswered. The validation is a hot topic of debate where opinions differ strongly. Under optimal conditions the qNMR will be accepted as a valid primary method (similar to a balance), recent developments more commonly tend to base the qNMR validation on the comprehensive chromatographic guidelines, e.g. according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). An import role plays the topic of data security and storage of raw data. Currently, there are isolated discussion groups at European at American level being part of the PANIC meeting. Cooperation is still not in sight. 

However, the qNMR meeting in Cologne, organized by Spectral Service on June 10, 2016, was the first step of cooperation with the future object of increasing the focus on qNMR. With 37 national and international attendees from authority, industry and university the meeting was a total success.

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 The wide-ranging program included on the one hand presentations of the current status of the qNMR and on the other hand, it was a knowledge-transfer of ISO17025, validation, Round Robin Tests, quantification and statistical methods. In principle, it was determined that the foundation of a new qNMR group is not the object, but rather the greater cooperation of all qNMR groups at the international level. In this context a public discussion platform should be created to support the knowhow-transfer and to increase the cooperation of harmonization.


Tab. 1  (Click title to download the presentation)

What's going on in PANIC's NMR Validation Group?

Torsten Schönberger, Bundeskriminalamt (BKA)

qNMR under ISO/IEC 17025 and ISO Guide 34

Alexander Rück

Merck/Sigma-Aldrich

qNMR metrology and "primary" reference

Dr. habil. Michael Maiwald, Bundesanstalt für Material-forschung und –prüfung (BAM)

Round Robin Test: Do you know the performance of your qNMR method?

Dr. Tanja Beyer,

Spectral Service

Round Robin Test: Edible and Krill Oil Analysis

Elina Zailer,

Spectral Service

qNMR – an independent discipline

Dr. Bernd Diehl,

Spectral Service

Improving the Performance of qNMR Evaluation by a Hybrid Approach:

Integration & Deconvolution

Torsten Schönberger, Bundeskriminalamt (BKA)

The importance of the relaxation time for qNMR

Patrick Jonas,

Spectral Service,

Hochschule Bonn-Rhein-Sieg

Processing and analysis data for qNMR:

steps and challenges to higher throughput

Dr. Mike Bernstein,

Mestrelab Research

Quantification by statistical methods?

Prof. Dr. Stephan Schwarzinger,

FZ BIOmac - Universität Bayreuth

und ALNuMed GmbH

Quantitative NMR in polymer analysis

Dr. Frank Malz,

Fraunhofer LBF