[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR74.1317]
 
 [Page 405]
 
                         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]
 
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