Molar Substitution Determination in Hydroxypropyl Betadex According to USP-NF/Ph. Eur. (1804) Monograph Method Using 1H Benchtop NMR

Cyclodextrins are used as ingredients in many different approved medicines, partially due to their hydrophobic interior and hydrophilic exterior, which allows them to form complexes with hydrophobic compounds. In this application note, we demonstrate that benchtop NMR spectroscopy is capable of determining the molar substitution in hydroxypropyl betadex samples in compliance with the USP-NF/Ph. Eur. (1804) monograph methods. The results included herein were used to officially update the USP-NF monograph method, after which the magnetic field requirements for the method were lowered from 6 Tesla (1H frequency = 250 MHz) to 1.4 Tesla (1H frequency = 60 MHz). This was the first time an official USP-NF method was modified to allow for the use of a lower magnetic field strength, a very important step towards increasing the use of benchtop NMR instruments in QA/QC spaces.