21 CFR 73.1299 - Ferric ferrocyanide.

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§ 73.1299 Ferric ferrocyanide.
(a) Identity.
(1) The color additive ferric ferrocyanide is a ferric hexacyanoferrate pigment characterized by the structual formula Fe4[Fe(CN)6]3·XH2O, which may contain small amounts of ferric sodium ferrocyanide and ferric potassium ferrocyanide.
(2) Color additive mixtures for drug use made with ferric 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 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.
[43 FR 54235, Nov. 21, 1978]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-06-11; vol. 79 # 112 - Wednesday, June 11, 2014
    1. 79 FR 33431 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.
      21 CFR Part 73

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 73 after this date.

  • 2014-06-11; vol. 79 # 112 - Wednesday, June 11, 2014
    1. 79 FR 33431 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.
      21 CFR Part 73