[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: 21CFR74.3106]
[Page 422]
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 D Medical Devices
Sec. 74.3106 D&C Blue No. 6.
(a) Identity. The color additive D&C Blue No. 6 is principally
[[Delta]2,2'-biindoline]-3,3' dione (CAS Reg. No. 482-89-3).
(b) Specifications. D&C Blue No. 6 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 (275 [deg]F), not more than 3 percent.
Matter insoluble in N,N- dimethylformamide, not more than 1 percent.
Isatin, not more than 0.3 percent.
Anthranilic acid, not more than 0.3 percent.
Indirubin, not more than 1 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 95 percent.
(c) Uses and restrictions. (1) D&C Blue No. 6 may be safely used at
a level--
(i) Not to exceed 0.2 percent by weight of the suture material for
coloring polyethylene terephthalate surgical sutures for general
surgical use;
(ii) Not to exceed 0.25 percent by weight of the suture material for
coloring plain or chromic collagen absorbable sutures for general
surgical use;
(iii) Not to exceed 0.5 percent by weight of the suture material for
coloring plain or chromic collagen absorbable sutures for ophthalmic
surgical use;
(iv) Not to exceed 0.5 percent by weight of the suture material for
coloring polypropylene surgical sutures for general surgical use; and
(v) Not to exceed 0.5 percent by weight of the suture material for
coloring polydioxanone synthetic absorbable sutures for ophthalmic and
general surgical use.
(2) Authorization for these uses shall not be construed as waiving
any of the requirements of sections 510(k), 515, and 520(g) of the
Federal Food, Drug, and Cosmetic Act with respect to the medical device
in which the color additive is used.
(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. 6 shall be certified
in accordance with regulations in part 80 of this chapter.
[49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at
50 FR 30698, July 29, 1985]
Back to Top
© 2007 Betterchem Corp.
|
