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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 74 after this date.

  • 2017-01-23; vol. 82 # 13 - Monday, January 23, 2017
    1. 82 FR 7648 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016.
      21 CFR Parts 73 and 74
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