[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: 21CFR74.1205]
[Page 396-397]
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. 74.1205 D&C Green No. 5.
(a) Identity. (1) The color additive D&C Green No. 5 is principally
the disodium salt of 2,2'-[(9,10-dihydro-9,10-dioxo-1,4-
anthracenediyl)diimino]bis-[5-methylbenzenesulfonic acid] (CAS Reg. No.
4403-90-1).
(2) Color additive mixtures for use in drugs made with D&C Green No.
5 may contain only those diluents that are suitable and those that are
listed in part 73 of this chapter for use in color additive mixtures for
coloring drugs.
(b) Specifications. (1) D&C Green No. 5 for use in coloring surgical
sutures 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 current good manufacturing practice:
[[Page 397]]
Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates
(calculated as sodium salts), not more than 20 percent.
Water insoluble matter, not more than 0.2 percent.
1,4-Dihydroxyanthraquinone, not more than 0.2 percent.
2-Amino-m-toluenesulfonic acid, not more than 0.2 percent.
Subsidiary colors, not more than 5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 80 percent.
(2) D&C Green No. 5 for use in coloring drugs shall conform to the
following specifications and shall be free from impurities other than
those named to the extent that such other impurities may be avoided by
current good manufacturing practice:
Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates
(calculated as sodium salts), not more than 20 percent.
Water-insoluble matter, not more than 0.2 percent.
1,4-Dihydroxyanthraquinone, not more than 0.2 percent.
Sulfonated toluidines, total not more than 0.2 percent.
p-Toluidine, not more than 0.0015 percent.
Sum of monosulfonated D&C Green No. 6 and Ext. D&C Violet No. 2, not
more than 3 percent.
Lead (as Pb), not more than 20 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 80 percent.
(c) Use and restrictions. (1) D&C Green No. 5 may be safely used to
color nylon 66 (the copolymer of adipic acid and hexamethylenediamine)
and/or nylon 6[poly-(e-caprolactam)]nonabsorbable surgical sutures for
use in general surgery, subject to the following restrictions:
(i) The quantity of color additive does not exceed 0.6 percent by
weight of the suture.
(ii) When the sutures are used for the purposes specified in their
labeling, there is no migration of the color additive to the surrounding
tissue.
(iii) If the suture is a new drug, an approved new drug application,
under section 505 of the act, is in effect for it.
(2) D&C Green No. 5 may be safely used for coloring drugs generally,
including drugs intended for use in the area of the eye, in amounts
consistent with current good manufacturing practice.
(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 Green No. 5 shall be certified
in accordance with regulations in part 80 of this chapter.
[47 FR 24284, June 4, 1982; 47 FR 27551, June 25, 1982, as amended at 59
FR 40805, Aug. 10, 1994]
Back to Top
© 2007 Betterchem Corp.
|
