[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: 21CFR74.1317]
[Page 402]
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. 74.1317 D&C Red No. 17.
(a) Identity. (1) The color additive D&C Red No. 17 is principally
1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol.
(2) Color additive mixtures for drug use made with D&C Red No. 17
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. 17 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:
Volatile matter (at 135 [deg]C), not more than 5 percent.
Matter insoluble in both toluene and water (color additive mixed in
toluene and the resultant residue isolated and mixed with water to
obtain the matter insoluble in both toluene and water), not more than
0.5 percent.
Chlorides and sulfates (calculated as sodium salts), not more than 3
percent.
Aniline, not more than 0.2 percent.
4-Aminoazobenzene, not more than 0.1 percent.
2-Naphthol, not more than 0.2 percent.
1-(Phenylazo)-2-naphthol, not more than 3 percent.
1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 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 90 percent.
(c) Uses and restrictions. D&C Red No. 17 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. 17 shall be certified
in accordance with regulations in part 80 of this chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 42 FR 27225, May 27, 1977]
[[Page 403]]
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