Pure dye (as determined by titration with titanium trichloride), not less than 87.0 percent.

§ 9.155 D&C Red No. 10.

Monosodium salt of 2-(2-hydroxy-1naphthylazo) - 1 naphthalenesulfonic

acid.

Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

Tobias acid, not more than 0.2 percent. p-Naphthol, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.156 D&C Red No. 11.

Calcium salt of 2-(2-hydroxy-1-naphthylazo)-1-naphthalenesulfonic acid. Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

Tobias acid, not more than 0.2 percent. B-Naphthol, not more than 0.2 percent. Chlorides and sulfates (as calcium salts), not more than 5.0 percent.

Oxides of iron and aluminum, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.157 D&C Red No. 12.

Barium salt of 2-(2-hydroxy-1-naphthylazo)-1-naphthalenesulfonic acid. Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

Tobias acid, not more than 0.2 percent. B-Naphthol, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 5.0 percent.

Oxides of iron and aluminum, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.158 D&C Red No. 13.

Strontium salt of 2-(2-hydroxy-1naphthylazo) - 1 - naphthalenesulfonic acid.

Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

Tobias acid, not more than 0.2 percent. B-Naphthol, not more than 0.2 percent. Chlorides and sulfates (as sodium salts), not more than 5.0 percent.

Oxides of iron and aluminum, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.159 D&C Red No. 14.

Monosodium salt of 1-0-carboxyphenylazo-2-naphthol.

Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

8-Naphthol, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.162 D&C Red No. 17.

1-p-Phenylazophenylazo-2-naphthol. Volatile matter (at 135° C.), not more than 5.0 percent.

Insoluble matter (in toluene), not more than 3.0 percent.

Aniline, not more than 0.2 percent Amino-azobenzene, not more than 0.2

percent.

B-Naphthol, not more than 0.2 percent. Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.164 D&C Red No. 19.

3-Ethochloride of 9-0-carboxyphenyl6 - diethylamino-3-ethylimino-3-isoxanthene.

Volatile matter (at 135° C.), not more than 5.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts (from acid solution), not more than 0.5 percent.

Diethyl-m-aminophenol, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 2.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 92.0 percent.

§ 9.166 D&C Red No. 21.

2,4,5,7-Tetrabromo-3,6-fluorandiol. Volatile matter (at 135° C.), not more than 6.0 percent.

Insoluble matter (alkaline solution), not more than 1.0 percent.

Ether extracts (from alkaline solution), not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 2.0 percent.

Mixed oxides, not more than 1.0 percent.

Free bromine, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye, 47.5-51.5 percent.

Pure dye (as determined gravimetrically), not less than 93.0 percent. § 9.167 D&C Red No. 22.

Disodium salt of 2,4,5,7-tetrabromo-9o-carboxyphenyl-6-hydroxy-3-isoxan

Permitted range of organically combined bromine in pure dye, 38.5-42.5 percent.

Permitted range of organically combined chlorine in pure dye, 16.0-19.0 percent.

Pure dye (as determined gravimetrically), not less than 90.0 percent.

§ 9.173 D&C Red No. 28.

Disodium salt of 2,4,5,7-tetrabromo-9(3,4,5,6-tetrachloro-o-carboxyphenyl)

6-hydroxy-3-isoxanthone.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Free halogens, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye 36.5-40.5 percent.

Permitted range of organically combined chlorine in pure dye, 16.0-18.0 percent.

Pure dye (as determined gravimetrically), not less than 85.0 percent. § 9.174 D&C Red No. 29.

1,4,5,8,15 - Pentabromo-2,7-dicarboxy3,6-fluorandiol.

Volatile matter (at 135° C.), not more than 2.0 percent.

Sulfated ash, not more than 1.0 percent.

Insoluble matter (alkaline solution), not more than 0.3 percent.

Soluble matter (in 1 percent aqueous hydrochloric acid), not more than 2.0 percent.

Free bromine, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye, 47.0-51.0 percent.

Pure dye (as determined gravimetrically), not less than 95.0 percent. § 9.175

D&C Red No. 30.

5,5′ - Dichloro-3,3′ - dimethyl – thioindigo.

Volatile matter (at 135° C.), not more than 5.0 percent.

Matter insoluble in xylene, not more than 1.0 percent.

Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.176 D&C Red No. 31.

Calcium salt of 3-hydroxy-4-phenylazo-2-naphthoic acid.

Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

Aniline, not more than 0.2 percent. Chlorides and sulfates (as calcium salts), not more than 5.0 percent.

Oxides of iron and aluminum, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.178 D&C Red No. 33.

Disodium salt of 8-amino-2-phenylazo-1-naphthol-3,6-disulfonic acid. Volatile matter (at 135° C.), not more than 6.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Aniline, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 10.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

§ 9.179 D&C Red No. 34.

Calcium salt of 4-(1-sulfo-2-naphthylazo)-3-hydroxy-2-naphthoic acid. Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts, not more than 0.5 percent.

Tobias acid, not more than 0.2 percent. Chlorides and sulfates (as calcium salts), not more than 10.0 percent.

Oxides of iron and aluminum, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

Stearic acid (not part of the dye), not more than 50.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 50.0 percent.

§ 9.184 D&C Red No. 39.

o-[p-(p,p'-Dihydroxy-diethylamino) phenylazol-benzoic acid.

Volatile matter (at 100° C.), not more than 2.0 percent.

Matter insoluble in acetone, not more than 1.5 percent.

Ether extract (petroleum ether), not more than 0.5 percent.

NN(B,p'-Dihydroxy-diethyl)

not more than 0.2 percent.

aniline,

Sulfated ash, not more than 1.5 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 95.0 percent.

§ 9.201 D&C Orange No. 4.

Monosodium salt of 1-p-sulfophenylazo-2-naphthol.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

B-Naphthol, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined gravimetrically), not less than 85.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.202

D&C Orange No. 5. 4,5-Dibromo-3,6-fluorandiol.

Volatile matter (at 135° C.), not more than 5.0 percent.

Insoluble matter (alkaline solution), not more than 1.0 percent.

Ether extracts (from alkaline solution), not more than 0.5 percent. Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Free bromine, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye, 31.0-35.0 percent.

Pure dye (as determined gravimetrically), not less than 90.0 percent.

§ 9.207 D&C Orange No. 10.

4,5-Diiodo-3,6-fluorandiol.

Volatile matter (at 135° C.), not more than 5.0 percent.

Insoluble matter (alkaline solution), not more than 1.0 percent.

Ether extracts (from alkaline solution), not more than 0.5 percent.

Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Free iodine, not more than 0.05 percent.

Permitted range of organically combined iodine in pure dye, 41.5-45.5 percent.

Pure dye (as determined gravimetrically), not less than 85.0 percent.

§ 9.208 D&C Orange No. 11.

Disodium salt of 9-o-carboxyphenyl-6hydroxy-4,5-diiodo-3-isoxanthone. Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Free iodine, not more than 0.05 percent.

Permitted range of organically combined iodine in pure dye, 38.5-42.5 percent.

§ 9.214 D&C Orange No. 17.

1-(2.4-Dinitrophenylazo) -2-naphthol. Volatile matter (at 135° C.), not more than 5.0 percent.

Sulfated ash, not more than 1.0 per

cent.

Matter insoluble in toluene, not more than 1.5 percent.

2,4-Dinitroaniline, not more than 0.2

percent.

B-Naphthol, not more than 0.2 percent. Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.240 D&C Blue No. 4.

Diammonium salt of 4-{[-(N-ethylp-sulfobenzylamino)-phenyl]-(2-sulfo

niumphenyl) - methylene}-[1-(N-ethylN-p -sulfobenzyl) – ▲1 - cyclohexadienimine].

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of ammonium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

§ 9.242 D&C Blue No. 6.

Indigotin.

Volatile matter (at 135° C.), not more than 5.0 percent.

Sulfated ash, not more than 2.0 per

cent.

Matter insoluble in dichlorhydrin, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 95.0 percent.

§ 9.245 D&C Blue No. 9.

3,3'-Dichloroindanthrene

Volatile matter (at 135° C.), not more than 1.0 percent.

Sulfated ash, not more than 1.0 per

cent.

2-Amino anthraquinone, not more than 0.2 percent.

Matter extractable by alcoholic HCI, not more than 1.0 percent.

Volatile matter (at 135° C.), not more than 2.0 percent.

Sulfated ash, not more than 1.0 percent.

Matter insoluble in carbon tetrachloride, not more than 1.5 percent.

p-Toluidine, not more than 0.2 percent. Pure dye (as calculated from organically combined nitrogen), not less than 96.0 percent.

Melting point, not less than 185° C. § 9.280 Lakes (D&C).

(a) (1) General. Any lake, other than those listed in Subpart B, made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or any combination of two or more of these, (i) one of the straight colors (except lakes) listed in Subpart B or hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium; or (ii) a salt prepared from one of the straight colors (except lakes) listed in Subpart B, or hereinbefore listed in this subpart, by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium.

(2) Specifications.

Ether extracts, not more than 0.5 percent.

Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent. Intermediates, not more than 0.2

percent.

(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows:

(1) The listed name of the color from which the lake is prepared, except that if such name contains the symbol "FD&C" such symbol shall be changed to "D&C";

(2) The name of the basic radical combined in such color; and

(3) The word "Lake."

(For example, the name of a lake prepared by extending the color D&C Red No. 9 upon a substratum is "D&C Red No. 9 Barium Lake", and a lake prepared by extending the aluminum salt prepared from FD&C Green No. 1 upon a substratum other than alumina is "D&C Green No. 1-Aluminum Lake".) Subpart D-Straight Colors and Specifications for Their Certification for Use in Externally Applied Drugs and Cosmetics

§ 9.307

Ext D&C Yellow No. 7. Disodium salt of 2,4-dinitro-1-naphthol-7-sulfonic acid.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 0.2 percent.

Ether extracts, not more than 0.1 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Martius yellow, not more than 0.03 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.