(a) Identity.

1. (1) The color additive D&C Yellow No. 8 is principally the disodium salt of fluorescein.
2. (2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 8 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 externally applied drugs.

(b) Specifications. D&C Yellow No. 8 shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in alkaline water, not more than 0.3 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 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 85 percent.