[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: 21CFR74.1339]
[Page 407-408]
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. 74.1339 D&C Red No. 39.
(a) Identity. (1) The color additive D&C Red No. 39 is o-
[p([beta],[beta]'-dihydroxy-diethylamino)-phenylazo]-benzoic acid.
(2) Color additive mixtures made with D&C Red No. 39 may contain the
following diluents: Water, acetone, isopropyl alcohol, and specially
denatured alcohols used in accordance with 26 CFR part 212.
(b) Specifications. D&C Red No. 39 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:
Volatile matter (at 100 [deg]C.), not more than 2.0 percent.
Matter insoluble in acetone, not more than 1.0 percent.
Anthranilic acid, not more than 0.2 percent.
[[Page 408]]
N,N-([beta],[beta]'-Dihydroxy-diethyl) aniline, not more than 0.2
percent.
Subsidiary colors, not more than 3.0 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 95.0 percent.
(c) Uses and restrictions. The color additive D&C Red No. 39 may be
safely used for the coloring of quaternary ammonium type germicidal
solutions intended for external application only, and subject to the
further restriction that the quantity of the color additive does not
exceed 0.1 percent by weight of the finished drug product.
(d) Labeling. The label of the color additive and any mixtures
prepared therefrom and 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 Red No. 39 shall be certified
in accordance with regulations promulgated under part 80 of this
chapter.
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