[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: 21CFR74.1711]

[Page 415]
 
                        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. 74.1711  D&C Yellow No. 11.

    (a) Identity. (1) The color additive D&C Yellow No. 11 is 
principally 2-(2-quinolyl)-1,3-indandione.
    (2) Color additive mixtures, for drug use made with D&C Yellow No. 
11 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 Yellow No. 11 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 1 percent.
Ethyl alcohol-insoluble matter, not more than 0.4 percent.
Phthalic acid, not more than 0.3 percent.
Quinaldine, not more than 0.2 percent.
Subsidiary colors, not more than 5 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 96 percent.

    (c) Uses and restrictions. D&C Yellow No. 11 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 Yellow No. 11 shall be 
certified in accordance with regulations in part 80 of this chapter.