FD&C Blue No. 2 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. 2 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. FD&C Blue No. 2 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. The FDA states that D&C Blue No. 2 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 colors (such as FD&C Blue No. 2 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
Top Medications with this excipient
- Acyclovir 200 mg (Actavis)
- Alprazolam 1 mg (Apotex Corp.)
- Alprazolam Extended-Release 3 mg (Actavis)
- Cesia desogestrel 0.1 mg / ethinyl estradiol 0.025 mg (Prasco Laboratories)
- Diltia XT 180 mg (Andrx Pharmaceuticals)
- Diltia XT 240 mg (Andrx Pharmaceuticals)
- Doxazosin Mesylate 1 mg (Ethex Corporation)
- Doxazosin Mesylate 8 mg (Ethex Corporation)
- Hydroxyzine Hydrochloride 25 mg (Mutual Pharmaceutical Company, Inc.)
- Oxycodone Hydrochloride 30 mg (Actavis)
- Oxycodone Hydrochloride 15 mg (Actavis)
- Paroxetine Hydrochloride 40 mg (Sun Pharmaceutical Industries Inc.)
- Paroxetine Hydrochloride 30 mg (Sun Pharmaceutical Industries Inc.)
- Sertraline Hydrochloride 25 mg (Zydus Pharmaceuticals USA Inc.)
- Sertraline Hydrochloride 25 mg (Watson Laboratories, Inc.)
- Sotalol Hydrochloride 80 mg (Mutual Pharmaceutical Company, Inc.)
- Sotalol Hydrochloride 120 mg (Mutual Pharmaceutical Company, Inc.)
- Sotalol Hydrochloride 160 mg (Mutual Pharmaceutical Company, Inc.)
- Sotalol Hydrochloride 240 mg (Mutual Pharmaceutical Company, Inc.)
- TROVAN 200 MG (Pfizer U.S. Pharmaceuticals Group)
