Nanalysis Benchtop NMR with USP Monographs and Betadex

Following our recent publication “Molar Substitution Determination in Hydroxypropyl Betadex According to USP-NF/Ph. Eur. (1804) Monograph Method Using 1H Benchtop NMR”, we’re happy to announce the approval of method revisions to the USP, which will be published in the Pharmacopeial Forum in March 2024. The USP Monograph will be updated to include 60 MHz NMR instruments.

In our comprehensive studies, we have demonstrated how Nanalysis benchtop NMR can be used instead of high field NMR with equivalent results, specifically in alignment with this monograph. Here’s a glimpse of what our findings reveal:

1. Accurate Molar Substitution Determination: Our benchtop NMR technology excels in accurately determining the molar substitution (MS) of hydroxypropyl betadex – the key parameter that effects performance – showcasing the reliability and precision required for your research.
2. Performance at Lower Magnetic Fields: Contrary to the standard 250 MHz requirement, our study demonstrates the efficacy of the 60 MHz instrument, offering excellent SNR and peak resolution. This ensures accurate MS calculations without compromising on performance. There is no need for more expensive instrumentation in house or outsourcing as 60 MHz represents the minimum viable tool. 
3. Efficient and Repeatable Analyses: Benefit from a streamlined analytical workflow, where sample preparation is facile, and each analysis takes only 5 minutes to complete and can be preformed directly in your own lab. Our results confirm reproducibility and repeatability across various hydroxypropyl betadex samples.
4. Versatility Across Sample Variations: The method was successfully applied to diverse hydroxypropyl betadex samples with different substitution ratios and/or patterns. Our technology adapts to different sample characteristics, providing a universal solution.

 To explore the complete findings and understand how Nanalysis benchtop NMR can seamlessly integrate into your workflows, I invite you to review the detailed application note which can be requested via this link.