[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1708]
[Page 410-411]
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. 74.1708 D&C Yellow No. 8.
(a) Identity. (1) The color additive D&C Yellow No. 8 is principally
the disodium salt of fluorescein.
(2) Color additive mixtures for use in externally applied drugs made
with D&C Yellow No. 8 may contain only those diluents that are suitable
and that are listed in part 73 of this chapter for use in color additive
mixtures for coloring externally applied drugs.
(b) Specifications. D&C Yellow No. 8 shall be free from impurities
other than those named to the extent that
[[Page 411]]
such impurities may be avoided by good manufacturing practice:
Sum of water and chlorides and sulfates (calculated as sodium salts),
not more than 15 percent.
Matter insoluble in alkaline water, not more than 0.3 percent.
Resorcinol, not more than 0.5 percent.
Phthalic acid, not more than 1 percent.
2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 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 85 percent.
(c) Uses and restrictions. D&C Yellow No. 8 may be safely used in
externally applied drugs in amounts consistent with good manufacturing
practice.
(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.
(e) Certification. All batches of D&C Yellow No. 8 shall be
certified in accordance with regulations in part 80 of this chapter.
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