21 CFR 74.1339 - D&C Red No. 39.

§ 74.1339 D&C Red No. 39.


(1) The color additive D&C Red No. 39 is o-[p(β,β′-dihydroxy-diethylamino)-phenylazo]-benzoic acid.

(2) Color additive mixtures made with D&C Red No. 39 may contain the following diluents: Water, acetone, isopropyl alcohol, and specially denatured alcohols used in accordance with 26 CFR part 212.

(b)Specifications. D&C Red No. 39 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:

Volatile matter (at 100 °C.), not more than 2.0 percent.
Matter insoluble in acetone, not more than 1.0 percent.
Anthranilic acid, not more than 0.2 percent.
N,N-(β,β′-Dihydroxy-diethyl) aniline, not more than 0.2 percent.
Subsidiary colors, not more than 3.0 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 95.0 percent.

(c)Uses and restrictions. The color additive D&C Red No. 39 may be safely used for the coloring of quaternary ammonium type germicidal solutions intended for external application only, and subject to the further restriction that the quantity of the color additive does not exceed 0.1 percent by weight of the finished drug product.

(d)Labeling. The label of the color additive and any mixtures prepared therefrom and 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 Red No. 39 shall be certified in accordance with regulations promulgated under part 80 of this chapter.

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 19-May-2018 03:57

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

  • 2017-05-31; vol. 82 # 103 - Wednesday, May 31, 2017
    1. 82 FR 24912 - Glo Eyes, LLC; Filing of Color Additive Petition
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of petition.
      The color additive petition was filed on April 18, 2017.
      21 CFR Part 74