Permitted range of organically combined iodine in pure dye, 32.0-36.0 percent.

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

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.

§ 9.230 D&C Brown No. 1.

Monosodium salt of 4-p-sulfophenylazo-2-(2,4-xylylazo)-1,3-resorcinol. 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.

m-Xylidine, not more than 0.2 per

cent.

Chlorides and sulfates of sodium, not more than 6.0 percent.

Mixed oxides, not more than 1.0 percent.

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

§ 9.240 D&C Blue No. 4.

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

niumphenyl) - methylene}-[1-(N-ethylN-p -sulfobenzyl) - A25 - 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.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Aniline, not more than 0.2 percent. p-Nitroaniline, 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.

$9.270 D&C Violet No. 2.

1-Hydroxy-4- p- toluino - anthra

quinone.

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. 89.280 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

A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use in externally applied drugs and cosmetics, if such batch conforms to the requirements of § 9.2 and to the specifications set forth in this subpart for such color.

§ 9.301 Ext D&C Yellow No. 1.

Monosodium salt of 4-m-sulfophenylazo-diphenylamine.

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

Water-insoluble matter, not more than 1.0 percent.

Chloroform-soluble matter, not more than 0.5 percent.

Diphenylamine, not more than 0.2

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 6.0 percent.

Mixed oxides, not more than 1.0 percent.

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

§ 9.305 Ext D&C Yellow No. 5. a-(o-Nitro-p-tolylazo) - acetoacetani

lide.

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

Sulfated ash, not more than 1.0 per

cent.

Matter insoluble in toluene, not more than 1.0 percent.

2-Nitro-p-toluidine, not more than 0.2

percent.

Pure dye (as determined by titration with titanium trichloride), not less than 96.0 percent.

Melting point, not less than 250° C. § 9.306 Ext D&C Yellow No. 6.

Disodium salt of 5-(p-sulfophenylazo) -salicylic acid.

Volatile matter (at 135° C.), not more than 3.0 percent.

Water-insoluble mater, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Sulfanilic acid, not more than 0.2 per

cent.

Salicylic acid, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 15.0 percent.

Mixed oxides, not more than 1.0 percent.

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

§ 9.307 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.

§ 9.340 Ext D&C Red No. 1.

Disodium salt of 8-acetamido-2-pacetamidophenylazo - 1 - naphthol - 3,6disulfonic acid.

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.

p-Amino acetanilid, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 6.0 percent.

Mixed oxides, not more than 1.0 percent.

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

§ 9.342

Ext D&C Red No. 3.

Disodium salt of 9-o-carboxyphenyl6-(4-sulfo - o - toluino)-3-0-tolylimino3-isoxanthene.

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.

o-Toluidine, not more than 0.2 percent. Mixed oxides, not more than 1.0 percent.

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

Pure dye (as determined by titration with titanium trichloride), not less than 80.0 percent.

§ 9.347 Ext D&C Red No. 8.

Monosodium salt of 4-(2-hydroxy-1naphthylazo) - 1 - naphthalenesulfonic

acid.

Volatile matter (at 135° C.), not more than 5.0 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 by titration with titanium trichloride), not less than 90.0 percent.

§ 9.349 Ext D&C Red No. 10. Disodium salt of 2-(4-sulfo-1-naphthylazo)-1-naphthol-4-sulfonic acid. 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.

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

§ 9.350 Ext D&C Red No. 11.

Disodium salt of 8-acetamido-2-phenylazo-1-naphthol-3,6-disulfonic acid. Volatile matter (at 135° C.), not more than 5.0 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

Ether extracts, not more than 0.5 percent.

Aniline, not more than 0.2 percent. p-Aminoazobenzene, not more than 0.2

percent.

Chlorides and sulfates of sodium, not more than 8.0 percent.

Mixed oxides, not more than 1.0 percent.

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

§ 9.353 Ext D&C Red No. 14.

1-Xylylazo-2-naphthol.

Volatile matter (at 100° C.), not more than 0.5 percent.

Sulfated ash, not more than 0.3 percent.

Water-soluble matter, not more than 0.3 percent.

Matter insoluble in carbon tetrachloride, not more than 0.5 percent.

Xylidine, not more than 0.1 percent. B-Naphthol, not more than 0.05 per

cent.

m-Xylidine in xylidine obtained by reduction of the dye, not more than 30.0 percent.

Pure dye (as determined by titration 'with titanium trichloride), not less than 97.0 percent.

Boiling range of xylidine, obtained by reduction of the dye, 95 percent between 212°-232° C.

§ 9.354 Ext D&C Red No. 15.

Disodium salts of a mixture of 1-alkylphenylazo-2-naphtho 1-3,6-disulfonic acids, of which the mixture of amines obtained by reduction of the dye shall have the following composition: 1-Amino-2,4,5-trimethylbenzene, less than 35 percent and not more than 45 percent.

not

1-Amino-2,4-dimethylbenzene, not less than 30 percent and not more than 40 percent.

1-Amino-2,5-dimethylbenzene, not less than 10 percent and not more than 20 percent.

1-Amino-2,6-dimethylbenzene, not less than 4 percent and not more than 12 percent.

1-Amino-2-ethylbenzene and 1-amino4-ethylbenzene, total not more than 5 percent.

1-Amino-2,3-dimethylbenzene and 1amino-3,4-dimethylbenzene, total not more than 4 percent.

1-Amino-2,3,4,6,- tetramethylbenzene, not more than 3 percent.

and

1-Amino-2,4,6-trimethylbenzene amino-methylethylbenzenes, total not more than 0.4 percent.

Aniline, toluidines, and 1-amino-2,3,4trimethylbenzene, not more than 1 percent of any individual amine and not more than 1.5 percent total of such amines.

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

Water-insoluble matter, not more than 0.5 percent.

Ether extracts, not more than 0.2 percent.

Uncombined intermediates, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 6.0 percent.

Mixed oxides, not more than 1.0 percent.

Lower sulfonated dyes, not more than 2.0 percent.

Pure dye, not less than 85.0 percent. Certificates issued heretofore for the color additive FD&C Red No. 1 and canceled by order (25 F.R. 11214) may be reissued for Ext D&C Red No. 15 (§ 9.354 of this chapter). [26 F.R. 162, Jan. 10, 1961]

§ 9.370 Ext D&C Blue No. 1.

3-Methochloride of 9-dimethylamino3-methylimino-3-isophenothiazine. Volatile matter (at 110° C.), not more than 16.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Dimethyl aniline, 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 82.0 percent.

§ 9.373 Ext D&C Blue No. 4.

Disodium salt of 4,8-diamino-1,5-dihydroxy-2,6-anthraquinone disulfonic acid. 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 10.0 percent.

Mixed oxides, not more than 1.0 percent.

§ 9.411

Ext D&C Violet No. 2. Monosodium salt of 1-hydroxy-4-(0sulfo-p-toluino) -anthraquinone.

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.

p-Toluidine, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 8.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 80.0 percent.