Isolation, characterization and determination of trace organic impurities in FD&C red no. 40.
The unsulfonated aromatic amine 4-nitro-p-cresidine (2-methoxy-5-methyl-4-nitrobenzenamine) was identified as an impurity in the regulated color additive FD&C Red. No. 40. The compound was isolated from the water-soluble color by extraction with chloroform, followed by transfer of the free amines to acid solution and subsequent separation by reversed-phase high-performance liquid chromatography. The 4-nitro-p-cresidine was collected and then identified by gas chromatography-mass spectrometry. The levels of 4-nitro-p-cresidine as well as p-cresidine and aniline were determined in commercial batches of FD&C Red. No. 40.
Richfield-Fratz
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Division of Colors and Cosmetics, Food and Drug Administration, Washington, DC 20204.
Baczynskyj
W M
WM
Miller
G C
GC
Bailey
J E
JE
D000814:Aniline Compounds / Q000032:analysis*; D001391:Azo Compounds / Q000032:analysis*; D055598:Chemical Phenomena; D002621:Chemistry; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination / Q000032:analysis; D005505:Food Coloring Agents / Q000032:analysis*; D008401:Gas Chromatography-Mass Spectrometry; D009574:Nitro Compounds / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet
D000814:Aniline Compounds; D001391:Azo Compounds; D005505:Food Coloring Agents; D009574:Nitro Compounds; C005915:Allura Red AC Dye; C060569:2-methoxy-5-methyl-4-nitroaniline