[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: 21CFR74.1333]
 
[Page 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. 74.1333  D&C Red No. 33.
 
    (a) Identity. (1) The color additive D&C Red No. 33 is principally
the disodium salt of 5-amino-4-hydroxy-3-(phenylazo)-2,7-
naphthalenedisulfonic acid (CAS Reg. No. 3567-66-6). To manufacture the
additive, the product obtained from the nitrous acid diazotization of
aniline is coupled with 4-hydroxy-5-amino-2,7-naphthalenedisulfonic acid
in an alkaline aqueous medium. The color additive is isolated as the
sodium salt.
    (2) Color additive mixtures for drug use made with D&C Red No. 33
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 drugs.
    (b) Specifications. D&C Red No. 33 shall conform to the following
specifications and shall be free from impurities other than those named
to the extent that such impurities may be avoided by current good
manufacturing practices:
 
Sum of volatile matter at 135 deg.C (275 deg.F) and chlorides and
sulfates (calculated as sodium salts), not more than 18 percent.
Water-insoluble matter, not more than 0.3 percent.
4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not
more than 0.3 percent.
4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium
salt, not more than 3.0 percent.
Aniline, not more than 25 parts per million.
4-Aminoazobenzene, not more than 100 parts per billion.
1,3-Diphenyltriazene, not more than 125 parts per billion.
4-Aminobiphenyl, not more than 275 parts per billion.
Azobenzene, not more than 1 part per million.
Benzidine, not more than 20 parts per billion.
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 82 percent.
 
    (c) Uses and restrictions. The color additive D&C Red. No 33 may be
safely used for coloring ingested drugs, other than mouthwashes and
dentifrices, in amounts not to exceed 0.75 milligram per daily dose of
the drug. D&C Red No. 33 may be safely used for coloring externally
applied drugs, mouthwashes, and dentifrices in amounts consistent with
current good manufacturing practice.
    (d) Labeling requirements. 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. 33 shall be certified
in accordance with regulations in part 80 of this chapter.
 
[53 FR 33120, Aug. 30, 1988]