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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
LC-MS characterization of trace impurities contained in calcium folinate
Giancarlo Francese1, Federica Corana, Olivia Meneghetti
1R and D Division, Cerbios-Pharma SA, via Pian Scairolo 6, CH-6917 Barbengo, Switzerland. giancarlofrancese@hotmail.com
Abstract:
An impurity present in calcium folinate (N5-formyl-5,6,7,8-tetrahydrofolic calcium salt) active pharmaceutical ingredient (API) was detected by high-performance liquid chromatography (HPLC). Through analysis by HPLC coupled with atmospheric-pressure chemical-ionization mass spectrometry (APCI-MS), a structure for this impurity was postulated and then proved by chemical synthesis.

