[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1306]

[Page 401]
 
                        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.  74.1306  D&C Red No. 6.

    (a) Identity. (1) The color additive D&C Red No. 6 is principally 
the disodium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-
naphthalenecarboxylic acid (CAS Reg. No. 5858-81-1). To manufacture the 
additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with 
hydrochloric acid and sodium nitrite. The diazo compound is coupled in 
alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid. The 
resulting dye precipitates as the disodium salt.
    (2) Color additive mixtures for drug use made with D&C Red No. 6 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. The color additive D&C Red No. 6 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:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 10 percent.
Ether-soluble matter, passes test entitled ``The Procedure for 
Determining Ether-Soluble Material in D&C Red Nos. 6 and 7,'' which is 
an Appendix A to part 74.
2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 
percent.
3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 
percent.
3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, sodium 
salt, not more than 0.5 percent.
p- Toluidine, not more than 15 parts per million.
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. The color additive D&C Red No. 6 may be 
safely used for coloring drugs such that the combined total of D&C Red 
No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of 
the drug.
    (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. 6 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 57687, Dec. 28, 1982]