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FD&C Blue No. 1 Aluminium Lake

Excipient (pharmacologically inactive substance)

What is it?

FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Blue No. 1 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. FD&C Blue No. 1 Aluminum Lake is approved for use in foods, drugs and cosmetics.

FD&C colors are the colors certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics. D&C notation specifies that the color can be used in drugs and cosmetics, but not food. According to the FDA, FD&C Blue No. 1 Aluminum Lake may be used safely as a color additive.

Lakes are formed by reacting straight colors (such as FD&C Blue No. 1 Aluminum) with precipitants and salts. Lakes may be used as color additives for tablet coatings due to their stability.[1][2]

[1] Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.2.31.35

[2] U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm

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