This electronic document was downloaded from the GPO web site, August 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

 
 [Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.1298]
 
 [Page 367]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                             Subpart B--Drugs
 
 Sec. 73.1298  Ferric ammonium ferrocyanide.
 
     (a) Identity. (1) The color additive ferric ammonium ferrocyanide is
 the blue pigment obtained by oxidizing under acidic conditions with
 sodium dichromate the acid digested precipitate resulting from mixing
 solutions of ferrous sulfate and sodium ferrocyanide in the presence of
 ammonium sulfate. The oxidized product is filtered, washed, and dried.
 The pigment consists principally of ferric ammonium ferrocyanide with
 smaller amounts of ferric ferrocyanide and ferric sodium ferrocyanide.
     (2) Color additive mixtures for drug use made with ferric ammonium
 ferrocyanide may contain only those diluents listed in this subpart as
 safe and suitable for use in color additive mixtures for coloring drugs.
     (b) Specifications. Ferric ammonium ferrocyanide shall conform to
 the following specifications and shall be free of impurities other than
 those named to the extent that the other impurities may be avoided by
 good manufacturing practice:
 
 Oxalic acid or its salts, not more than 0.1 percent.
 Water soluble matter, not more than 3 percent.
 Water soluble cyanide, not more than 10 parts per million.
 Volatile matter, not more than 4 percent.
 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.
 Total iron (as Fe corrected for volatile matter), not less than 33
 percent and not more than 39 percent.
 
     (c) Uses and restrictions. Ferric ammonium ferrocyanide may be
 safely used in amounts consistent with good manufacturing practice to
 color externally applied drugs, including those 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 Sec. 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
 therfore batches thereof are exempt from the certification requirements
 of section 721(c) of the act.
 
 [42 FR 38562, July 29, 1977, as amended at 44 FR 28322, May 15, 1979]


Color Additive Regulations
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