{"data":{"id":"us/21-cfr-74.1339","jurisdiction":"us","citation":"21 CFR 74.1339","heading":"D\u0026C Red No. 39.","body":"(a) Identity. (1) The color additive D\u0026C Red No. 39 is o-[p(β,β′-dihydroxy-diethylamino)-phenylazo]-benzoic acid.\n(2) Color additive mixtures made with D\u0026C Red No. 39 may contain the following diluents: Water, acetone, isopropyl alcohol, and specially denatured alcohols used in accordance with 26 CFR part 212.\n(b) Specifications. D\u0026C 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:\nVolatile matter (at 100 °C.), not more than 2.0 percent.\nMatter insoluble in acetone, not more than 1.0 percent.\nAnthranilic acid, not more than 0.2 percent.\nN,N-(β,β′-Dihydroxy-diethyl) aniline, not more than 0.2 percent.\nSubsidiary colors, not more than 3.0 percent.\nLead (as Pb), not more than 20 parts per million.\nArsenic (as As), not more than 3 parts per million.\nTotal color, not less than 95.0 percent.\n(c) Uses and restrictions. The color additive D\u0026C 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.\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 Red No. 39 shall be certified in accordance with regulations promulgated under 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":"7968cfa7458bdffca59e44e795c5014e1f11e6b4a4908472104e51c1b0cb16dc","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-74.1336","next":"us/21-cfr-74.1340"},"notice":"GroundRules: Original legal text. Not legal advice."}