LC-MS characterization of trace impurities contained in calcium folinate.
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.
Francese
Giancarlo
G
R and D Division, Cerbios-Pharma SA, via Pian Scairolo 6, CH-6917 Barbengo, Switzerland. giancarlofrancese@hotmail.com
Corana
Federica
F
Meneghetti
Olivia
O
Marazza
Fabrizio
F
D001274:Atmospheric Pressure; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D005973:Glutamine / Q000032:analysis; D007477:Ions; D002955:Leucovorin / Q000032:analysis* / Q000737:chemistry; D013058:Mass Spectrometry / Q000379:methods*; D008956:Models, Chemical; D004364:Pharmaceutical Preparations; D011312:Pressure; D012997:Solvents / Q000737:chemistry; D021241:Spectrometry, Mass, Electrospray Ionization; D013053:Spectrophotometry; D013237:Stereoisomerism; D013678:Technology, Pharmaceutical / Q000379:methods; D014466:Ultraviolet Rays
D007477:Ions; D004364:Pharmaceutical Preparations; D012997:Solvents; D005973:Glutamine; D002955:Leucovorin