[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1710]
 
[Page 408-409]
 
                        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. 74.1710  D&C; Yellow No. 10.
 
    (a) Identity. (1) The color additive D&C; Yellow No. 10 is a mixture
of the sodium salts of the mono- and disulfonic acids of 2-(2-
quinolinyl)-1H-indene-1,3 (2H)-dione consisting principally of the
sodium salts of 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-6-
quinolinesulfonic acid and 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-8-
quinolinesulfonic acid with lesser amounts of the disodium salts of the
disulfonic acids of 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione (CAS Reg.
No. 8004-92-0). D&C; Yellow No. 10 is manufactured by condensing
quinaldine with phthalic anhydride to give the unsulfonated dye, which
is then sulfonated with oleum.
    (2) Color additive mixtures made with D&C; Yellow No. 10 for drug use
may contain only those diluents that are suitable and that are listed in
part 73 of this chapter as safe for use in color additive mixtures for
coloring drugs.
    (b) Specifications. The color additive D&C; Yellow No. 10 shall
conform to the
 
[[Page 409]]
 
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:
 
Sum of volatile matter at 135  deg.C (275  deg.F) and chlorides and
sulfates (calculated as sodium salts), not more than 15 percent.
Matter insoluble in both water and chloroform, not more than 0.2
percent.
Total sulfonated quinaldines, sodium salts, not more than 0.2 percent.
Total sulfonated phthalic acids, sodium salts, not more than 0.2
percent.
2-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 4 parts per
million.
Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1H-indene-
1,3 (2H)-dione, not less than 75 percent.
Sum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1H-indene-
1,3 (2H)-dione, not more than 15 percent.
2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8-quinolinedisulfonic acid,
disodium salt, not more than 3 percent.
Diethyl ether soluble matter other than that specified, not more than 2
parts per million, using added 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione
for calibration.
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. The color additive D&C; Yellow No. 10 may
be safely used for coloring drugs generally in amounts consistent with
current good manufacturing practice.
    (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; Yellow No. 10 shall be
certified in accordance with regulations in part 80 of this chapter.
 
[48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]