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FD&C Blue No. 1 Aluminium Lake

Medically reviewed by Drugs.com. Last updated on Jun 20, 2024.

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]

Some examples of medications containing FD&C Blue No. 1 Aluminium Lake

References

  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

Further information

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