21 CFR 74.1327 - D&C Red No. 27.

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§ 74.1327 D&C Red No. 27.

(a)Identity.

(1) The color additive D&C Red No. 27 is principally 2′,4′,5′,7′-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 13473-26-2). The color additive is manufactured by brominating 4,5,6,7-tetrachlorofluorescein with elemental bromine. The 4,5,6,7-tetrachlorofluorescein is manufactured by the acid condensation of resorcinol and tetrachlorophthalic acid or its anhydride. The 4,5,6,7-tetrachlorofluorescein is isolated and partially purified prior to bromination.

(2) Color additive mixtures for drug use made with D&C Red No. 27 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 drugs.

(b)Specifications. D&C Red No. 27 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:

Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.
Insoluble matter (alkaline solution), not more than 0.5 percent.
Tetrachlorophthalic acid, not more than 1.2 percent.
Brominated resorcinol, not more than 0.4 percent.
2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.7 percent.
2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent.
Lower halogenated subsidiary colors, not more than 4 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 90 percent.

(c)Uses and restrictions. D&C Red No. 27 may be safely used for coloring drugs generally in amounts consistent with current 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 Red No. 27 shall be certified in accordance with regulations in part 80 of this chapter.

[47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982]

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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.

  • 2016-11-01; vol. 81 # 211 - Tuesday, November 1, 2016
    1. 81 FR 75689 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 2, 2016. See section IX for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by December 1, 2016.
      21 CFR Parts 73 and 74
The section you are viewing is cited by the following CFR sections.

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-11-01; vol. 81 # 211 - Tuesday, November 1, 2016
    1. 81 FR 75689 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 2, 2016. See section IX for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by December 1, 2016.
      21 CFR Parts 73 and 74