[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: 21CFR74.1261]
[Page 400]
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. 74.1261 D&C Orange No. 11.
(a) Identity. (1) The color additive D&C Orange No. 11 is a mixture
consisting principally of the disodium salts of 4',5'-diiodofluorescein,
2',4',5'-triiodofluorescein and 2',4',5',7'-tetraiodofluorescein.
(2) Color additive mixtures for drug use made with D&C Orange No. 11
may contain only those diluents listed in this subpart as safe and
suitable for use in color additive mixtures for coloring externally
applied drugs.
(b) Specifications. The color additive D&C Orange No. 11 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:
Sum of volatile matter (at 135 [deg]C) and halides and sulfates
(calculated as sodium salts), not more than 8 percent.
Water-insoluble matter, not more than 0.5 percent.
Phthalic acid, not more than 0.5 percent.
2-[3',5'-Diiodo-2',4'-dihydroxybenzoyl] benzoic acid, sodium salt, not
more than 0.5 percent.
Fluorescein, disodium salt, not more than 1 percent.
4'-Iodofluorescein, disodium salt, not more than 3 percent.
2',4'-Diiodofluorescein and 2',5'-diiodofluorescein, not more than 2
percent.
2',4',5'-Triiodofluorescein, not more than 35 percent.
2',4',5',7'-Tetraiodofluorescein, disodium salt, not more than 10
percent.
4',5'-Diiodofluorescein, disodium salt, not less than 60 percent and not
more than 95 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 92 percent.
(c) Uses and restrictions. D&C Orange No. 11 may be safely used for
coloring externally applied drugs in amounts consistent with good
manufacturing practice.
(d) Labeling requirements. 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. 11 shall be
certified in accordance with regulations in part 80 of this chapter.
[46 FR 18953, Mar. 27, 1981]
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