Code of Federal Regulations Title 21. Food and Drugs § 21.73.1299 Ferric ferrocyanide

(a) Identity.

(b) Specifications. Ferric ferrocyanide 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:

Water soluble cyanide, not more than 10 parts per million.

Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.

Nickel (as Ni), not more than 200 parts per million.

Cobalt (as Co), not more than 200 parts per million.

Mercury (as Hg), not more than 1 part per million.

Oxalic acid, not more than 0.1 percent.

Water soluble matter, not more than 3 percent.

Volatile matter, not more than 10 percent.

Total iron (as Fe corrected for volatile matter), not less than 37 percent and not more than 45 percent.

(c) Uses and restrictions. Ferric ferrocyanide may be safely used in amounts consistent with good manufacturing practice to color externally applied drugs including those intended for use in the area of the eye.

(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification requirements of section 721(c) of the act.