[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: 21CFR73.1329]
[Page 365-366]
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. 73.1329 Guanine.
(a) Identity. (1) The color additive guanine is the crystalline
material obtained from fish scales and consists principally of the two
purines, guanine and hypoxanthine. The guanine content will vary from 75
to 97 percent, and the hypoxanthine will vary from 3 to 25 percent,
depending on the particular fish and tissue from which the crystals are
derived.
(2) Color additive mixtures for drug use made with guanine may
contain only those diluents listed in this subpart as safe and suitable
for use in color additive mixtures for coloring externally applied
drugs.
(b) Specifications. The color additive guanine shall conform to the
following specifications and shall be free from impurities other than
those named to the extent that such other impurities may be avoided by
good manufacturing practice:
Guanine, not less than 75 percent.
Hypoxanthine, not more than 25 percent.
Ash (ignition at 800 [deg]C), not more than 2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Assay, not less than 96 percent total purines.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. Guanine is safe for use in coloring
externally applied drugs, including those intended for use in the area
of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom
intended solely or in part for coloring purposes shall bear, in addition
to any information required by law, labeling
[[Page 366]]
in accordance with 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
therefore batches therof are exempt from certification pursuant to
section 721(c) of the act.
[42 FR 37537, July 22, 1977]
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