[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
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 
(Cr2O3[middot]XH2O).
    (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 
Cr2O3 (based on sample weight).
Boron (as B2O3), not more than 8 percent.
Total volatile matter at 1000  deg.C, not more than 20%.
Cr2O3 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]