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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jul 20, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR74.1109]



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

Sec. 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 deg.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:

(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).

(2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture.

(3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue.

(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.

(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.

[42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 1993]

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