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: 21CFR73.1326]
 
 [Page 368]
 
                         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. 73.1326  Chromium hydroxide green.
 
     (a) Identity. (1) The color additive chromium hydroxide green is
 principally hydrated chromic sesquioxide
 (Cr<INF>2</INF>O<INF>3</INF><t-bullet>XH<INF>2</INF>O).
     (2) Color additive mixtures for drug use made with chromium
 hydroxide green may contain only those diluents listed in this subpart
 as safe and suitable for use in color additive mixtures for coloring
 drugs.
     (b) Specifications. Chromium hydroxide green shall conform to the
 following specifications and shall be free from impurities other than
 those named to the extent that such impurities may be avoided by good
 manufacturing practice:
 
 Water soluble matter, not more than 2.5%.
 Chromium in 2% NaOH extract, not more than 0.1% as Cr<INF>2</INF>O<INF>3</INF>
 (based on sample weight).
 Boron (as B<INF>2</INF>O<INF>3</INF>), not more than 8 percent.
 Total volatile matter at 1000 [deg]C, not more than 20%.
 Cr<INF>2</INF>O<INF>3</INF> not less than 75%.
 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.
 
     (c) Uses and restrictions. Chromium hydroxide green 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 lintended 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
 therefore batches thereof are exempt from the certification requirements
 of section 721(c) of the act.
 
 [42 FR 36451, July 15, 1977, as amended at 42 FR 59852, Nov. 22, 1977]


Color Additive Regulations
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