Code of Federal Regulations Title 21. Food and Drugs § 21.74.1109 D&C Blue No. 9

(a) Identity. The color additive D&C Blue No. 9 is principally 7,16–dichloro–6,15 - dihydro - 5,9,14,18 - anthrazine-tetrone.

(b) Specifications. D&C 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:

Volatile matter (at 135 °C.), not more than 3 percent.

Matter extractable by alcoholic HCl (0.1 ml of concentrated hydrochloric acid per 50 ml of 95 percent ethyl alcohol), not more than 1 percent.

2–Amino anthraquinone, not more than 0.2 percent.

Organically combined chlorine in pure dye, 13.0–14.8 percent.

Lead (as Pb), not more than 20 p/m.

Arsenic (as As), not more than 3 p/m.

Total color, not less than 97 percent.

(c) Uses and restrictions. D&C Blue No. 9 may be safely used for coloring cotton and silk surgical sutures, including sutures for ophthalmic use, subject to the following restrictions:

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of D&C Blue No. 9 shall be certified in accordance with regulations in part 80 of this chapter.