(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 °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 §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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