This electronic document was downloaded from the GPO web site, August 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1109]
[Page 399]
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]