[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: 21CFR74.1206]
[Page 397-398]
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. 74.1206 D&C Green No. 6.
(a) Identity. The color additive D&C Green No. 6 is 1,4-bis[(4-
methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128-80-3).
(b) Specifications. The color additive D&C Green No. 6 for use in
coloring externally applied 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:
Volatile matter (at 135 [deg]C), not more than 2.0 percent.
Water-soluble matter, not more than 0.3 percent.
Matter insoluble in carbon tetrachloride, not more than 1.5 percent.
p-Toluidine, not more than 0.1 percent.
1,4-Dihydroxyanthraquinone, not more than 0.2 percent.
1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than
5.0 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 96.0 percent.
(c) Uses and restrictions. The color additive D&C Green No. 6 may be
safely used for coloring externally applied drugs 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.
[[Page 398]]
(e) Certification. All batches of D&C Green No. 6 shall be certified
in accordance with regulations promulgated under part 80 of this
chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr.2, 1982; 47
FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986]
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