{"data":{"id":"us/21-cfr-74.1322","jurisdiction":"us","citation":"21 CFR 74.1322","heading":"D\u0026C Red No. 22.","body":"(a) Identity. (1) The color additive D\u0026C Red No. 22 is principally the disodium salt of 2′,4′,5′7′-tetrabromofluorescein (CAS Reg. No. 17372-87-1) and may contain smaller amounts of the disodium salts of 2′,4′,5′-tribromofluorescein and 2′,4′,7′-tribromofluorescein. The color additive is manufactured by alkaline hydrolysis of 2′,4′,5′,7′-tetrabromofluorescein. 2′,4′,5′,7′-Tetrabromofluorescein is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. Fluorescein is isolated and partially purified prior to bromination.\n(2) Color additive mixtures for drug use made with Red No. 22 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.\n(b) Specifications. The color additive D\u0026C Red No. 22 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:\nSum of volatile matter (at 135 °C) and halides and sulfates (calculated as soduim salts), not more than 10 percent.\nWater-insoluble matter not more than 0.5 percent.\nDisodium salt of phthalic acid, not more than 1 percent.\nSodium salt of 2-(3,5-Dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.5 percent.\n2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent.\nBrominated resorcinol, not more than 0.4 percent.\nSum of disodium salts of mono- and dibromofluoresceins, not more than 2 percent.\nSum of disodium salts of tribromofluoresceins, not more than 25 percent.\nDisodium salt of 2′,4′,5′,7′-Tetrabromofluorescein, not less than 72 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. The color additive D\u0026C Red No. 22 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\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 Red No. 22 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":"4fe5c5c2ee900d7f4d6381f600493ab9b7403bc32039d82bae908d0bb9ed398c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-74.1321","next":"us/21-cfr-74.1327"},"notice":"GroundRules: Original legal text. Not legal advice."}