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J Pharm Biomed Anal ; 39(3-4): 757-63, 2005 Sep 15.
Article in English | MEDLINE | ID: mdl-15927438

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.


Subject(s)
Chromatography, High Pressure Liquid/methods , Chromatography, Liquid/methods , Drug Contamination , Leucovorin/analysis , Mass Spectrometry/methods , Atmospheric Pressure , Chemistry, Pharmaceutical/methods , Glutamine/analysis , Ions , Leucovorin/chemistry , Models, Chemical , Pharmaceutical Preparations , Pressure , Solvents/chemistry , Spectrometry, Mass, Electrospray Ionization , Spectrophotometry , Stereoisomerism , Technology, Pharmaceutical/methods , Ultraviolet Rays
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