This electronic document was downloaded from the GPO web site, August 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: 21CFR74.1307]
 
 [Page 404-405]
 
                         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. 74.1307  D&C Red No. 7.
 
     (a) Identity. (1) The color additive D&C Red No. 7 is principally
 the calcium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-
 naphthalenecarboxylic acid (CAS Reg. No. 5281-04-9). To manufacture the
 additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with
 hydrochloric acid and sodium nitrite. The diazo compound is
 
 [[Page 405]]
 
 coupled in alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid
 and the resulting dye converted to the calcium salt with calcium
 chloride.
     (2) Color additive mixtures for drug use made with D&C Red 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 drugs.
     (b) Specifications. The color additive D&C Red No. 7 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, calcium salt, not more than 0.2
 percent.
 3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4
 percent.
 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium
 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. 7 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. 7 shall be certified
 in accordance with regulations in part 80 of this chapter.
 
 [47 FR 57687, Dec. 28, 1982]


Color Additive Regulations
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