{"data":{"id":"us/21-cfr-74.1255","jurisdiction":"us","citation":"21 CFR 74.1255","heading":"D\u0026C Orange No. 5.","body":"(a) Identity. (1) the color additive D\u0026C Orange No. 5 is a mixture consisting principally the sodium salt of 4′,5′-dibromofluorescein (CAS Reg. No. 596-03-2) and 2′,4′,5′-tribromofluorescein (CAS Reg. No. 25709-83-5) and 2′,4′,5′,7′-tetrabromofluorescein (CAS Reg. No. 15086-94-9). D\u0026C Orange No. 5 is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. The fluorescein is isolated and partially purified prior to bromination.\n(2) Color additive mixtures for drug use made with D\u0026C Orange No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs.\n(b) Specifications. D\u0026C Orange No. 5 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 good manufacturing practice.\n4′,5′-dibromofluorescein, not less than 50 percent and not more than 65 percent.\n2′,4′,5′-tribromofluorescein, not less than 30 percent and not more than 40 percent.\n2′,4′,5′,7′-tetrabromofluorescein, not more than 10 percent.\nSum of 2′,4′-dibromofluorescein and 2′,5′-dibromofluorescein, not more than 2 percent.\n4′-Bromofluorescein, not more than 2 percent.\nFluorescein, not more than 1 percent.\nPhthalic acid, not more than 1 percent.\n2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\nBrominated resorcinol, not more than 0.4 percent.\nSum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.\nInsoluble matter (alkaline solution), not more than 0.3 percent.\nLead (as Pb), not more than 20 parts per million.\nArsenic (as As), not more than 3 parts per million.\nMercury (as Hg), not more than 1 part per million.\nTotal color, not less than 90 percent.\n(c) Uses and restrictions. D\u0026C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested drugs in amounts consistent with current good manufacturing practice. D\u0026C Orange No. 5 may be safely used in externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug.\n(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.\n(e) Certification. All batches of D\u0026C Orange No. 5 shall be certified in accordance with regulations in part 80 of this chapter.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION","Subpart B—Drugs"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"98c8b5e454e73f785bf12cb828ff9ef002e8cfffb5cc7d26fec3be0f5b5b7d9b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-74.1254","next":"us/21-cfr-74.1260"},"notice":"GroundRules: Original legal text. Not legal advice."}