[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1328]

[Page 430-431]
 
                        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. 74.1328  D&C Red No. 28.

    (a) Identity. (1) The color additive D&C Red No. 28 is principally 
the disodium salt of 2',4',5',7'-tetrabromo-4,5,6,7-
tetrachlorofluorescein (CAS Reg. No. 18472-87-2) formed by alkaline 
hydrolysis of the parent tetrabromotetrachlorofluorescein.
    (2) Color additive mixtures for drug use made with D&C Red No. 28 
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. 28 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 practice:


[[Page 431]]


Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as sodium salts), not more than 15 percent.
Insoluble matter (alkaline solution), not more than 0.5 percent.
Tetrachlorophthalic acid, not more than 1.2 percent.
Brominated resorcinol, not more than 0.4 percent.
2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, 
not more than 0.7 percent.
2',4',5',7'-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not 
more than 2 percent.
Lower halogenated subsidiary colors, not more than 4 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. D&C Red No. 28 may be safely used for 
coloring drugs generally in amounts consistent with current 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. 28 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 42568, Sept. 28, 1982]