[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: 21CFR74.1327]
 
 [Page 407]
 
                         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. 74.1327  D&C Red No. 27.
 
     (a) Identity. (1) The color additive D&C Red No. 27 is principally
 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No.
 13473-26-2). The color additive is manufactured by brominating 4,5,6,7-
 tetrachlorofluorescein with elemental bromine. The 4,5,6,7-
 tetrachlorofluorescein is manufactured by the acid condensation of
 resorcinol and tetrachlorophthalic acid or its anhydride. The 4,5,6,7-
 tetrachlorofluorescein is isolated and partially purified prior to
 bromination.
     (2) Color additive mixtures for drug use made with D&C Red No. 27
 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. 27 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 halides and sulfates
 (calculated as sodium salts), not more than 10 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 90 percent.
 
     (c) Uses and restrictions. D&C Red No. 27 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. 27 shall be certified
 in accordance with regulations in part 80 of this chapter.
 
 [47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982]