D&C Yellow No. 10 Aluminium Lake
Medically reviewed by Drugs.com. Last updated on Jul 28, 2021.
Excipient (pharmacologically inactive substance)
What is it?
FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. D&C Yellow No. 10 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. D&C Yellow No. 10 Aluminum Lake is approved for use in drugs and cosmetics but it is not approved as a colorant for food.
FD&C colors are the colors certified for use by the U.S. FDA in the food, drug, and cosmetic industry. The D&C notation specifies the color is approved only for drugs and cosmetics. The FDA states that D&C Yellow No. 10 Aluminum Lake may be safely used as a color additive when their specifications are followed.
According to the FDA, lakes are formed by reacting straight dyes (such as D&C Yellow No. 10) with precipitants and salts. Lakes may be used as color additives for tablet coatings due to their stability.
Top medications with this excipient
- Amphetamine and Dextroamphetamine Extended Release 5 mg
- Amphetamine and Dextroamphetamine Extended Release 20 mg
- Fluphenazine Hydrochloride 2.5 mg
- Fluphenazine Hydrochloride 5 mg
- Metolazone 10 mg
- Paroxetine Extended-Release 12.5 mg
- Prednisone 1 mg
- Sunitinib Malate 12.5 mg
- Sunitinib Malate 25 mg
- Sunitinib Malate 37.5 mg
- Sunitinib Malate 50 mg
- 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%3A126.96.36.199.27;idno=21;cc=ecfr#21:188.8.131.52.184.108.40.206
- 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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