21 CFR 74.1602 - D&C Violet No. 2.

§ 74.1602 D&C Violet No. 2.
(a) Identity.
(1) The color additive D&C Violet No. 2 is principally 1-hydroxy -4-[(4-methylphenyl)amino]-9,10-anthracenedione.
(2) Color additive mixtures for use in externally applied drugs made with D&C Violet No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.
(b) Specifications. 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 can be avoided by good manufacturing practice:
Volatile matter (at 135 °C.), not more than 2.0 percent.
Matter insoluble in both carbon tetrachloride and water, not more than 0.5 percent.
p- Toluidine, not more than 0.2 percent.
1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent.
1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent.
Subsidiary colors, not more than 1.0 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 96.0 percent.
(c) Uses and restrictions. The color additive D&C Violet No. 2 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.
(d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
(e) Certification. All batches of D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 45 FR 62978, Sept. 23, 1980; 55 FR 18868, May 7, 1990]

Title 21 published on 2014-04-01

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