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Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2012;29(9):1386-90. doi: 10.1080/19440049.2012.696216. Epub 2012 Jul 10.

Determination of synthetic by-products and an intermediate in the colour additive D&C Orange No. 5 using high-performance liquid chromatography.

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Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD 20740, USA.


Specifications in the US Code of Federal Regulations for the colour additive D&C Orange No. 5 (Colour Index No. 45370:1) limit the levels of the synthetic by-products 2-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid (Br2BBA) and brominated resorcinol (Br3R) as well as the level of the intermediate phthalic acid (PhthAc). The present work reports the development and application of a high-performance liquid chromatography (HPLC) method for the quantitative determination of these impurities in D&C Orange No. 5 and its lakes. Br2BBA, Br3R and PhthAc were quantified by using five-point calibration curves with data points that ranged from 0.010% to 0.700%, from 0.012% to 0.706% and from 0.006% to 1.383% by weight, respectively. The HPLC method was applied to the analysis of test portions from 11 lots of D&C Orange No. 5 and one lot of D&C Orange No. 5 lake submitted to the US Food and Drug Administration (USFDA) for certification.

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