(1) The color additive D&C Red No. 7 is principally the calcium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-naphthalenecarboxylic acid (CAS Reg. No. 5281-04-9). To manufacture the additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid and the resulting dye converted to the calcium salt with calcium chloride.
(2) Color additive mixtures for drug use made with D&C Red No. 7 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. 7 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 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent.
1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 percent.
3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 percent.
3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium salt, not more than 0.5 percent.
p-Toluidine, not more than 15 parts per million.
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. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 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 § 70.25 of this chapter.
(e)Certification. All batches of D&C Red No. 7 shall be certified in accordance with regulations in part 80 of this chapter.