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FDA Changes Specs and Test for Two Red Dyes

WASHINGTON (CN) - The Food and Drug Administration has revised requirements for D&C Red Nos. 6 and 7 by replacing the current specification and test for a certain recently identified impurity.

The FDA has replaced the specification for "Ether-soluble matter" with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol, by request of Sun Chemical Corp.

The test the FDA uses to certify each batch of these dyes before they legally may be used in drugs and cosmetics marketed in the United States no longer will be done by visible spectrophotometry, but by reversed-phase high performance liquid chromatography.

Click the document icon for this regulation and others.

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