[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: 21CFR74.1255 ]
 
 [Page 401-402]
 
                         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. 74.1255  D&C Orange No. 5.
 
     (a) Identity. (1) the color additive D&C Orange No. 5 is a mixture
 consisting principally the sodium salt of 4',5'-dibromofluorescein (CAS
 Reg. No.
 
 [[Page 402]]
 
 596-03-2) and 2',4',5'-tribromofluorescein (CAS Reg. No. 25709-83-5) and
 2',4',5',7'-tetrabromofluorescein (CAS Reg. No. 15086-94-9). D&C Orange
 No. 5 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; Orange No. 5
 may contain only those diluents that are suitable and that are listed in
 part 73 of this chapter for use in color additive mixtures for coloring
 drugs.
     (b) Specifications. D&C Orange No. 5 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 good manufacturing
 practice.
 
 4',5'-dibromofluorescein, not less than 50 percent and not more than 65
 percent.
 2',4',5'-tribromofluorescein, not less than 30 percent and not more than
 40 percent.
 2',4',5',7'-tetrabromofluorescein, not more than 10 percent.
 Sum of 2',4'-dibromofluorescein and 2',5'-dibromofluorescein, not more
 than 2 percent.
 4'-Bromofluorescein, not more than 2 percent.
 Fluorescein, not more than 1 percent.
 Phthalic acid, not more than 1 percent.
 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5
 percent.
 Brominated resorcinol, not more than 0.4 percent.
 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 0.3 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 Orange No. 5 may be safely used for
 coloring mouthwashes and dentifrices that are ingested drugs in amounts
 consistent with current good manufacturing practice. D&C Orange No. 5
 may be safely used in externally applied drugs in amounts not exceeding
 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 Orange No. 5 shall be
 certified in accordance with regulations in part 80 of this chapter.
 
 [47 FR 44635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984]