Impurity Identification with LC-MS and LC-NMR
Do you have impurity problems, metabolite or degradant identification issues? Catalent Pharma Solutions can help!
As a front-line approach for the identification of unknowns, Catalent is equipped with state of the art MS and NMR instrumentation and industry leading expertise.
We have several LC-MS instruments including a high resolution Micromass Q-Tof-2 mass spectrometer capable of accurate mass measurements (< 5 ppm), a Finnigan LCQ mass spectrometer capable of MS n structural analysis and a variety of single quadrupoles for nominal mass measurements. For more non-polar volatile or semi-volatile unknowns, we also have several database-equipped GC-MS instruments.
We also have a 500 MHz 3-channel Varian Unity Inova NMR spectrometer equipped with an LC-Flow probe to combine the separation power of liquid chromatography with the chemical-structure-determination utility of NMR. LC-NMR allows the separation and identification of complex mixtures by yielding NMR spectra of the individual components.
Whether you have a low level process impurity observed in your initial API screening, a drug product related degradant observed on stability or any unknown in between, Catalent can solve your problem.
Ranitidine and three related impurities at the level of 10%, 1%, and 0.1%, acquired by LC-NMR in stop-flow mode
MSn Illustrating structural Elucidation by LC-MS
For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.