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: 21CFR74.1206]
 
 [Page 400-401]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                             Subpart B--Drugs
 
 Sec. 74.1206  D&C Green No. 6.
 
     (a) Identity. The color additive D&C Green No. 6 is 1,4-bis[(4-
 methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128-80-3).
     (b) Specifications. The color additive D&C Green No. 6 for use in
 coloring externally applied drugs 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 current good
 manufacturing practice:
 
 Volatile matter (at 135 deg.C), not more than 2.0 percent.
 Water-soluble matter, not more than 0.3 percent.
 Matter insoluble in carbon tetrachloride, not more than 1.5 percent.
 p-Toluidine, not more than 0.1 percent.
 1,4-Dihydroxyanthraquinone, not more than 0.2 percent.
 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than
 5.0 percent.
 Lead (as Pb), not more than 20 parts per million.
 Arsenic (as As), not more than 3 parts per million.
 Mercury (as Hg), not more than 1 part per million.
 Total color, not less than 96.0 percent.
 
     (c) Uses and restrictions. The color additive D&C Green No. 6 may be
 safely used for coloring externally applied drugs in amounts consistent
 with current good manufacturing practice.
     (d) Labeling. The label of the color additive shall conform to the
 requirements of Sec. 70.25 of this chapter.
 
 [[Page 401]]
 
     (e) Certification. All batches of D&C Green No. 6 shall be certified
 in accordance with regulations promulgated under part 80 of this
 chapter.
 
 [42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr.2, 1982; 47
 FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986]

Color Additive Regulations
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