{"data":{"id":"us/21-cfr-74.1109","jurisdiction":"us","citation":"21 CFR 74.1109","heading":"D\u0026C Blue No. 9.","body":"(a) Identity. The color additive D\u0026C Blue No. 9 is principally 7,16-dichloro-6,15 - dihydro - 5,9,14,18 - anthrazine-tetrone.\n(b) Specifications. D\u0026C Blue No. 9 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:\nVolatile matter (at 135 °C.), not more than 3 percent.\nMatter extractable by alcoholic HCl (0.1 ml of concentrated hydrochloric acid per 50 ml of 95 percent ethyl alcohol), not more than 1 percent.\n2-Amino anthraquinone, not more than 0.2 percent.\nOrganically combined chlorine in pure dye, 13.0-14.8 percent.\nLead (as Pb), not more than 20 p/m.\nArsenic (as As), not more than 3 p/m.\nTotal color, not less than 97 percent.\n(c) Uses and restrictions. D\u0026C Blue No. 9 may be safely used for coloring cotton and silk surgical sutures, including sutures for ophthalmic use, subject to the following restrictions:\n(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).\n(2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture.\n(3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue.\n(4) If the suture is a new drug, a new-drug application approved pursuant to section 505 of the act is in effect for it.\n(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.\n(e) Certification. All batches of D\u0026C Blue No. 9 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":"2d9c2220819d28d186c5a88c7b196410fe1e99ef2635920015fe4a9303b6f270","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-74.1104","next":"us/21-cfr-74.1203"},"notice":"GroundRules: Original legal text. Not legal advice."}