cGMP NMR Services
NMR analyses have traditionally been reserved for research and development purposes helping elucidate molecular structure, study molecular interaction and profile chemically and biologically relevant molecular dynamics. These applications usually require careful sample preparation, extensive data acquisition and detailed data analysis and consequently, are often underutilized due to resource limitations. However, NMR has been finding increasing use in maintaining quality and safety in the production of food, pharmaceuticals and medical devices. Key advantages for using NMR cGMP analysis are specificity, linearity, quantitation, and ease of method development.
A few areas where early success in applying cGMP NMR revolve around quantitative studies including:
- Residual Solvents
- Heparin Impurities
- Process Impurities
- Stability Studies
Manufacturers are finding that cGMP NMR analysis provides competitive advantages allowing faster and more specific assays leading to a better understanding and control of manufacturing and storage of products.
Novatia’s cGMP NMR
Novatia has been providing NMR services for nearly 15 years. With three NMR specialists, a combined research experience of over 100 years and 500 MHz NMR instrumentation, we are uniquely positioned to assist our customers in developing new cGMP NMR assays and transferring established assays to our laboratory.
Please note that our instrumentation is qualified for one-dimensional proton work only.
We would also be able to perform customer methods for carbon, fluorine, or phosphorous nuclei.
Contact us today for your cGMP NMR analysis needs.