Pharmaceuticals Research

A collaboration between Bruker and Merck has led to the development of certified reference material (CRM) tailored to qNMR. A novel, two-component mixture that is manufactured in the ISO/IEC 17025 and ISO 17034 accreditated workflow at the Merck site in Buchs, Switzerland, and it is the basis of the new qPQ test. This qPQ is now incorporated within the Bruker AssureSST™ software, allowing automated PQ tailored to qNMR.

Markus Obkircher, Director of Reference Materials R&D at Merck, commented: “This product could only be realized within such a short timeframe by a transparent and collaborative innovation approach and by bringing together core competences of Bruker and Merck in the field of quantitative NMR, reference materials development and metrology. The application of the qPQ Certified Reference Material in Bruker’s AssureSST platform will enable scientists to accurately acquire and process NMR data based on a time-saving, robust, standardized and validated workflow.”

Merck KGaA Darmstadt, Germany, holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

qNMR PQ Test with Dedicated Certified Reference Material in a Standard Work Flow

For pharmaceutical development and production facilities, the requirement to perform process qualification is well known. Vendors of sub-systems and instruments that are incorporated within (or otherwise support), pharmaceutical development and manufacturing typically supply tailored qualification documents (IQ/OQ/PQ/CSV). This is exactly the case for Bruker BioSpin, where the overall approach to qualification of high resolution NMR instruments has recently been described in a white paper.