D&C Yellow No. 10 Aluminium Lake
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.[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
Top Medications with this excipient
- Acetaminophen and Propoxyphene Hydrochloride 650 mg / 65 mg (Watson Pharmaceuticals)
- Acyclovir 800 mg (Actavis)
- Acyclovir 200 mg (Actavis)
- Alprazolam Extended Release 1 mg (Actavis)
- Alprazolam Extended-Release 3 mg (Actavis)
- Benazepril Hydrochloride 5 mg (Watson Laboratories, Inc.)
- Benazepril Hydrochloride 10 mg (Watson Laboratories, Inc.)
- Bethanechol Chloride 50 mg (Lannett Company, Inc.)
- Clonazepam 0.5 mg (Watson Pharmaceuticals)
- Clonazepam 1 mg (Watson Pharmaceuticals)
- Diltia XT 180 mg (Andrx Pharmaceuticals)
- Diltia XT 240 mg (Andrx Pharmaceuticals)
- Doxazosin Mesylate 2 mg (Ethex Corporation)
- Glyburide (Micronized) 6 mg (Greenstone Limited)
- Ismo 20 mg (Promius Pharma)
- Lovastatin 40 mg (Actavis)
- Oxycodone Hydrochloride 15 mg (Actavis)
- Paroxetine Hydrochloride 10 mg (Sun Pharmaceutical Industries Inc.)
- Sertraline Hydrochloride 25 mg (Zydus Pharmaceuticals USA Inc.)
- Sertraline Hydrochloride 25 mg (Watson Laboratories, Inc.)
