[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: 21CFR74.1321]
 
 [Page 406]
 
                         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. 74.1321  D&C Red No. 21.
 
     (a) Identity. (1) The color additive D&C Red No. 21 is principally
 2',4',5',7'-tetrabromofluorescein (CAS Reg. No. 15086-94-9), and may
 contain smaller amounts of 2',4',5'-tribromofluorescein (CAS Reg. No.
 25709-83-5) and 2',4',7'- tribromofluorescein (CAS Reg. No. 25709-84-6).
 The color additive is manufactured by brominating fluorescein with
 elemental bromine. The fluorescein is manufactured by the acid
 condensation of resorcinol and phthalic acid or its anhydride. The
 fluorescein is isolated and partially purified prior to bromination.
     (2) Color additive mixtures for drug use made with D&C Red No. 21
 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. 21 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.
 Phthalic acid, not more than 1 percent.
 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5
 percent.
 2',4',5',7'-Tetrabromofluorescein, ethyl ester, not more than 1 percent.
 Brominated resorcinol, not more than 0.4 percent.
 Fluorescein, not more than 0.2 percent.
 Sum of mono- and dibromofluoresceins, not more than 2 percent.
 Tribromofluoresceins, not more than 11 percent.
 2',4',5',7'-Tetrabromofluorescein, not less than 87 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. The color additive D&C Red No. 21 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. 21 shall be certified
 in accordance with regulations in part 80 of this chapter.
 
 [47 FR 53846, Nov. 30, 1982]