[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: 21CFR74.1602]
[Page 408-409]
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. 74.1602 D&C Violet No. 2.
(a) Identity. (1) The color additive D&C Violet No. 2 is principally
1-hydroxy -4-[(4-methylphenyl)amino]-9,10-anthracenedione.
(2) Color additive mixtures for use in externally applied drugs made
with D&C Violet No. 2 may contain only those diluents that are suitable
and that are listed in part 73 of this chapter as safe for use in color
additive mixtures for coloring externally applied drugs.
(b) Specifications. D&C Violet No. 2 shall conform to the following
specifications and shall be free from impurities, other than those
named, to the extent that such other impurities can be avoided by good
manufacturing practice:
Volatile matter (at 135 [deg]C.), not more than 2.0 percent.
Matter insoluble in both carbon tetrachloride and water, not more than
0.5 percent.
p- Toluidine, not more than 0.2 percent.
1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent.
1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent.
Subsidiary colors, not more than 1.0 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 96.0 percent.
(c) Uses and restrictions. The color additive D&C Violet No. 2 may
be safely used for coloring externally applied drugs in amounts
consistent with good manufacturing practice.
(d) Labeling. The label of the color additive and any mixtures
prepared therefrom intended solely or in part for
[[Page 409]]
coloring purposes shall conform to the requirements of Sec. 70.25 of
this chapter.
(e) Certification. All batches of D&C Violet No. 2 shall be
certified in accordance with regulations in part 80 of this chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 45 FR 62978, Sept. 23, 1980;
55 FR 18868, May 7, 1990]
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