This electronic document was downloaded from the GPO web site, September 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version. 
[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: 21CFR74.1707a]
 
[Page 413]
 
                        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. 74.1707a  Ext. D&C Yellow No. 7.
 
    (a) Identity. (1) The color additive Ext. D&C Yellow No. 7 is
principally the disodium salt of 8-hydroxy-5,7-di-nitro-2-
naphthalenesulfonic acid.
    (2) Color additive mixtures for drug use made with Ext. D&C Yellow
No. 7 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. Ext. D&C Yellow No. 7 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 15 percent.
Water-insoluble matter, not more than 0.2 percent.
1-Naphthol, not more than 0.2 percent.
2,4-Dinitro-1-naphthol, not more than 0.03 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 85 percent.
 
    (c) Uses and restrictions. Ext. D&C Yellow No. 7 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 Ext. D&C Yellow No. 7 shall be
certified in accordance with regulations in part 80 of this chapter.

Color Additive Regulations
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