[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: 21CFR74.1255]
[Page 398-399]
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 399]]
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]
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