[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1109]

[Page 396]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                             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 Sec.  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]