21 C.F.R. § 74.2602a Ext. D&C Violet No. 2.
Title 21 - Food and Drugs
(a) Identity. The color additive Ext. D&C Violet No. 2 is principally the monosodium salt of 2-[(9,10-dihydro-4-hydroxy -9,10-dioxo-1-anthracenyl) amino]-5-methyl-benzenesulfonic acid. (b) Specifications. Ext. D&C Violet No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:
Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.4 percent. 1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent. p- Toluidine, not more than 0.1 percent. p- Toluidine sulfonic acids, sodium salts, not more than 0.2 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 80 percent. (c) Uses and restrictions. The color additive Ext. D&C Violet No. 2 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of Ext. D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter.
Title 21: Food and Drugs
PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
Subpart C—Cosmetics
§ 74.2602a Ext. D&C Violet No. 2.
