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Home > Drugs > FD&C Blue No. 2 Aluminium Lake

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]

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