Automatizing the qualitative and quantitative analysis of complex drugs using NMR
This webinar will introduce a technique called 2D heteronuclear single quantum coherence (HSQC) NMR spectroscopy for assessing the quality control of heparin. Currently, this is achieved using 1D NMR spectroscopy, following the indication of international pharmacopoeia. However, although 1D spectra can help to confirm the chemical structures of heparin products, it cannot readily identify variability in its composition between batches, which can occur due to differences in the purification methods used and the extraction source selected. The 2D HSQC NMR spectroscopy method, on the other hand, can be used to detect this variability. Once established, the method was automated to take advantage of NMR’s inherent reproducibility and reduce operator to operator variations and prepare for method validation of this quality control approach.
Using heparin as an example, implementation of the 2D HSQC NMR approach will be described, with a focus on the key parameters and evaluation of sources of variability inherent to the technique. Attention to factors influencing limit of detection, linearity, accuracy and precision are necessary in the development of a robust method for a given material. Another important topic will be how the method can be automated to take advantage of NMR’s inherent reproducibility, reduce operator-to-operator variations and prepare for method validation of this quality control approach. The idea is to develop a method that can not only be used in specialized NMR labs designed to work with this type of drug, but also in the routine control of heparin production and batch release by different pharmaceutical companies. The method was automated using tools in Assure NMR software for qualitative assessment of porcine verses bovine heparin and quantitative analysis of heparins and impurities. The instrument operational performance was also automated to assist with GxP compliance.
Who should attend
The webinar will be of interest to the following individuals:
- Quality managers, scientists and technicians who are responsible for the quality control of pharmaceuticals and/or biologics
- Users of qNMR
- Students considering careers in analytical chemistry and quality assurance