[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: 21CFR73.1125]
 
 [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 Contents
 
                             Subpart B--Drugs
 
 Sec. 73.1125  Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).
 
     (a) Identity. (1) The color additive potassium sodium copper
 chlorophyllin is a green to black powder obtained from chlorophyll by
 replacing the methyl and phytyl ester groups with alkali and replacing
 the magnesium with copper. The source of the chlorophyll is dehydrated
 alfalfa.
     (2) Color additive mixtures for drug use made with potassium sodium
 copper chlorophyllin may contain only those diluents that are suitable
 and that are listed in this subpart as safe for use in color additive
 mixtures for coloring drugs.
     (b) Specifications. Potassium sodium copper chlorophyllin 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:
 
 Moisture, not more than 5.0 percent.
 Nitrogen, not more than 5.0 percent.
 pH of 1 percent solution, 9 to 11.
 Total copper, not less than 4 percent and not more than 6 percent.
 Free copper, not more than 0.25 percent.
 Iron, not more than 0.5 percent.
 Lead (as Pb)), not more than 20 parts per million.
 Arsenic (as As), not more than 5 parts per million.
 Ratio, absorbance at 405 m[mu] to absorbance at 630 m[mu],
 not less than 3.4 and not more than 3.9.
 Total color, not less than 75 percent.
 
     (c) Uses and restrictions. Potassium sodium copper chlorophyllin may
 be safely used for coloring dentifrices that are drugs at a level not to
 exceed 0.1 percent. Authorization for this use shall not be construed as
 waiving any of the requirements of section 505 of the act with respect
 to the drug in which it is used.
     (d) Labeling. The label of the color additive and any mixtures
 prepared therefrom intended solely or in part for coloring purposes
 shall conform to the requirements of Sec. 70.25 of this chapter.
 
 [[Page 366]]
 
     (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 the certification requirements
 of section 721(c) of the act.