Code of Federal Regulations Title 21. Food and Drugs § 21.73.1025 Ferric ammonium citrate

(a) Identity. The color additive ferric ammonium citrate consists of complex chelates prepared by the interaction of ferric hydroxide with citric acid in the presence of ammonia. The complex chelates occur in brown and green forms, are deliquescent in air, and are reducible by light.

(b) Specifications. Ferric ammonium citrate 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:

Iron (as Fe), not less than 14.5 percent and not more than 18.5 percent.

Lead (as Pb), not more than 20 p/m.

Arsenic (as As), not more than 3 p/m.

(c) Uses and restrictions. Ferric ammonium citrate may be safely used in combination with pyrogallol (as listed in § 73.1375), for coloring plain and chromic catgut sutures for use in general and ophthalmic surgery subject to the following conditions:

(d) Labeling. The labeling of the color-additive 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 the requirements of section 721(c) of the act.