{"data":{"id":"us/21-cfr-74.1602","jurisdiction":"us","citation":"21 CFR 74.1602","heading":"D\u0026C Violet No. 2.","body":"(a) Identity. (1) The color additive D\u0026C Violet No. 2 is principally 1-hydroxy -4-[(4-methylphenyl)amino]-9,10-anthracenedione.\n(2) Color additive mixtures for use in externally applied drugs made with D\u0026C Violet No. 2 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 externally applied drugs.\n(b) Specifications. D\u0026C Violet No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities can be avoided by good manufacturing practice:\nVolatile matter (at 135 °C.), not more than 2.0 percent.\nMatter insoluble in both carbon tetrachloride and water, not more than 0.5 percent.\np- Toluidine, not more than 0.2 percent.\n1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent.\n1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent.\nSubsidiary colors, not more than 1.0 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 96.0 percent.\n(c) Uses and restrictions. The color additive D\u0026C Violet No. 2 may be safely used for coloring externally applied drugs in amounts consistent with 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 Violet No. 2 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":"f885da79c2270873acc28be843caf447a8a458354f3db28e77619558a880c487","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-74.1340","next":"us/21-cfr-74.1705"},"notice":"GroundRules: Original legal text. Not legal advice."}