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: 21CFR73.1329]
 
 [Page 369]
 
                         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. 73.1329  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 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]


Color Additive Regulations
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