FD&C Blue No. 2 (B2, mainly the disodium salt of 3'-dioxo-[delta<sup>2,2'</sup>-biindoline]-5,5'-disulfonate, Indigotine) is a color additive permitted for use in foods, drugs, and certain medical devices. B2 is manufactured by heating indigo (or indigo paste) in the presence of sulfuric acid. The starting material is obtained by the fusion of <i>N</i>-phenylglycine, which in turn originates from aniline and formaldehyde. B2 is batch certified by the U.S. Food and Drug Administration to ensure compliance with regulatory requirements listed in the Code of Federal Regulations. We have developed and validated a new ultra-high-performance liquid chromatography and tandem mass spectrometry (LC-MS/MS) method for directly determining aniline and other unsulfonated aromatic amines in B2 following extraction using a modified QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe”) technique. The new LC-MS/MS method is extremely sensitive and may be used to screen for the analytes as potential good manufacturing practice violations. The ready-to-use extraction kits provide for faster and easier implementation. A description of the new method and validation results will be presented.

Determination of aniline and other unsulfonated aromatic amines in FD&C blue no. 2 using LC-MS/MS

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.