NMR & EPR Pharma Solutions

qNMR

Quantitative NMR, direct efficent solution for potency determination. Now also under GxP!

Faits marquants

Highlights

End to End
Workflow Oriented
Data Integrity

Potency determination, absolute compound purity assessment, identity testing, residual solvent, moisture analysis, relative response factor calculation... Have you thought about using quantitative NMR as a one-stop solution?

Potency determination by qNMR has been shown to be a single point replacement for routine development testing which previously involved several experiments and techniques[1] and a superior method for determining the purity of the reference standards[2] used for analysis with assured metrological traceability[3] such as standards for HPLC.

The downside is that existing qNMR workflows rely on expert knowledge and/or well-trained analysts and detailed protocols. Bruker-Mestrelab new tools for potency/purity determination streamline this process with a fully automatic workflow from experiment submission to report, making it the ideal solution for both experts and non-experts working in a pharmaceutical development environment, where quality is a must.

 

Caractéristiques

Mdrive qNMR Key Features

  • Web-based sample and analysis management.
  • Automated data analysis comprises potency calculation, using values obtained by integrating either automatically selected or predefined spectral regions.
  • Error analysis within the sample when multiple analyte peaks are integrated, averaged and the RSD given.
  • Wide range of integration methods, including Global Spectra Deconvolution (GSD) and quantitative GSD (qGSD).
  • Results are delivered in electronic format and as PDFs, with customisable templates.
  • Rapid qNMR method development based on optimized default, but configurable, parameter sets for acquisition, processing and analysis.

The automatic data analysis is based on Bruker and Mestrelab proven algorithms for NMR quantification. These are either automatically called from Mdrive or they can be manually executed. In addition to the automatic analysis, all processing features and the subsequent analysis are accessible for manual work in an easy-to-use fashion.

Mdrive qNMR GxP

Building on the new GxP readiness platform, our qNMR product now provides full traceability from initial question to result, together with detailed control over users and their rights. It can be operated by a variety of users, experts, and non-experts. Web based experiment submission guaranties log in and out without compromise. Structured around a database, it enables data integrity and management of qNMR methods. These methods are typically designed by method developers, approved by method verifiers, and deployed to the laboratory scientists. Efficient analytical request management with instrument time optimization, in a GxP environment, is now possible for qNMR.

 

qPQ Quantitative Performance Qualification test  and certified reference standard and
 

New tools for Data Integrity (DI), compliance and good laboratory and manufacturing practices.

 

Literature

1. Webster G.F. and Kumar S., Anal Chem, 86, 11474 (2014)

2. Pauli G.F., Godecke T., Jaki B.U. and Lankin D.C., J Nat Prod, 75, 834 (2012)

3. Japanese Pharmacopeia XVII, General Tests and Apparatus, p. 137

 

Avantages

Benefits

  • Versatile: no need for a chemically identical reference material. Commercially available reference standards are used.
  • Faster: NMR is inherently quantitative. There is no need to calculate response factors or calibration curves.
  • All-in-one: potency and structure confirmation in one single experiment. Organic and inorganic materials are taken into account. No need to use additional techniques.
  • Accurate: use of internal standard eliminates errors introduced by inherent sample differences.
  • Reproducible: an automated workflow from acquisition to analysis decreases human error and variability.
  • ·Intuitive and flexible: straightforward manual interaction when desired.

     

Support

Labscape

Service & Life Cycle Support for Magnetic Resonance and Preclinical Imaging

Bruker’s commitment to provide customers with unparalleled help throughout the buying cycle, from initial inquiry to evaluation, installation, and the lifetime of the instrument is now characterized by the LabScape service concept.

LabScape Maintenance Agreements, On-Site On-Demand and Enhance Your Lab are designed to offer a new approach to maintenance and service for the modern laboratory