High resolution nuclear magnetic resonance (NMR) is a microstructural technique with single atomic site resolution and specificity. As such, it is one of the most powerful tools available to the chemist for structure elucidation.
NEW: Heparin impurities testing capabilities
Catalent added the revised USP monographs for heparin sodium and heparin calcium to the array of testing capabilities. The revised monograph requires a 500 MHz NMR spectrometer to directly detect the impurity identified as a health concern.
In direct response to the recent heparin crisis, the U.S. Pharmacopeia (USP) revised the monographs for heparin sodium and heparin calcium on June 18th, 2008. The revised heparin monographs utilize both Nuclear Magnetic Resonance (NMR) spectroscopy and Capillary Electrophoresis (CE) to detect the presence oversulfated chondroitin in heparin drug products. For more information see the USP and FDA pages on heparin.
Additional NMR testing services are listed below.
Applications:
- Structure determination of drug substances
- Purity assays for release testing
- Analysis of impurities in formulated pharmaceuticals
- Identification of unknown compounds
- Analysis of metabolites of pharmaceutical ingredients
- Quantitative analysis of the composition of polymers
- NMR analysis of biologics
Capabilities
- 500 MHz Varian INOVA™ spectrometer
- Multinuclear, variable temperature 1, 2 and 3D NMR
- Switchable direct 5mm probe with a wide range of nuclei
- Triple resonance indirect 3mm probe
- Specialty probes allowing detection in the sub µg limit
- Flow probe for LC-NMR
We perform all USP and European Pharmacopeia methods according to the strictest GLP/GMP guidelines. We will also develop and validate custom methods to your needs. Routine analysis, problem solving and contract research opportunities are welcome.
For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.