[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: 21CFR74.1331]
[Page 405-406]
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. 74.1331 D&C Red No. 31.
(a) Identity. (1) The color additive D&C Red No. 31 is principally
the calcium salt of 3-hydroxy-4-(phenylazo)-2-naphthalenecarboxylic
acid.
(2) Color additive mixtures for drug use made with D&C Red No. 31
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 Red No. 31 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 good
manufacturing practice:
Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates
(calculated as sodium salts), not more than 10 percent.
Aniline, not more than 0.2 percent.
3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent.
Subsidiary colors, not more than 1 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.
[[Page 406]]
Total color, not less than 90 percent.
(c) Uses and restrictions. D&C Red No. 31 may be safely used in
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 coloring purposes
shall conform to the requirements of Sec. 70.25 of this chapter.
(e) Certification. All batches of D&C Red No. 31 shall be certified
in accordance with regulations in part 80 of this chapter.
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