[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1298]
[Page 363-364]
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
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.
[[Page 364]]
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]
Back to Top
© 2007 Betterchem Corp.
|
