{"data":{"id":"us/21-cfr-74.1710","jurisdiction":"us","citation":"21 CFR 74.1710","heading":"D\u0026C Yellow No. 10.","body":"(a) Identity. (1) The color additive D\u0026C Yellow No. 10 is a mixture of the sodium salts of the mono- and disulfonic acids of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione consisting principally of the sodium salts of 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-6-quinolinesulfonic acid and 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-8-quinolinesulfonic acid with lesser amounts of the disodium salts of the disulfonic acids of 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione (CAS Reg. No. 8004-92-0). D\u0026C Yellow No. 10 is manufactured by condensing quinaldine with phthalic anhydride to give the unsulfonated dye, which is then sulfonated with oleum.\n(2) Color additive mixtures made with D\u0026C Yellow No. 10 for drug use 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 Yellow No. 10 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 current good manufacturing practice:\nSum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\nMatter insoluble in both water and chloroform, not more than 0.2 percent.\nTotal sulfonated quinaldines, sodium salts, not more than 0.2 percent.\nTotal sulfonated phthalic acids, sodium salts, not more than 0.2 percent.\n2-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 4 parts per million.\nSum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not less than 75 percent.\nSum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 15 percent.\n2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8-quinolinedisulfonic acid, disodium salt, not more than 3 percent.\nDiethyl ether soluble matter other than that specified, not more than 2 parts per million, using added 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione for calibration.\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 85 percent.\n(c) Uses and restrictions. The color additive D\u0026C Yellow No. 10 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 and 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 Yellow No. 10 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":"4f43a4adce4e47754c682b2b39695b432226e169aa427158041b7c88d69c8932","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-74.1708","next":"us/21-cfr-74.1711"},"notice":"GroundRules: Original legal text. Not legal advice."}