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.
MeSH terms
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Atmospheric Pressure
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Chemistry, Pharmaceutical / methods
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Chromatography, High Pressure Liquid / methods*
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Chromatography, Liquid / methods*
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Drug Contamination*
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Glutamine / analysis
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Ions
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Leucovorin / analysis*
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Leucovorin / chemistry
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Mass Spectrometry / methods*
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Models, Chemical
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Pharmaceutical Preparations
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Pressure
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Solvents / chemistry
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Spectrometry, Mass, Electrospray Ionization
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Spectrophotometry
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Stereoisomerism
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Technology, Pharmaceutical / methods
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Ultraviolet Rays
Substances
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Ions
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Pharmaceutical Preparations
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Solvents
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Glutamine
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Leucovorin