§ 9.175 D&C Red No. 30.

5,5'-Dichloro-3,3′-dimethyl-thioin

digo.

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.

NOTE: See note under § 9.130. § 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.

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

§ 9.182 D&C Red No. 37.

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

Volatile matter (at 80° C.), not more than 2.0 percent.

Sulfated ash, not more than 3.0 percent.

Matter insoluble in benzene, not more than 0.5 percent.

Diethyl-m-aminophenol,

than 0.2 percent.

not more

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.

NOTE: See note under § 9.130.

§ 9.183 D&C Red No. 38.

3-Hydroxy-N-(m-nitrophenyl)-4-(0nitro-p-tolylazo)-2-naphthamide.

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

Sulfated ash, not more than 1.5 percent.

Matter, insoluble in nitrobenzene, not more than 0.5 percent.

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

percent.

3-Hydroxy-N-(m-nitrophenyl)-2naphthamide, not more than 0.2 percent. Pure dye (as calculated from organically combined nitrogen), not less than 90.0 percent.

§ 9.184 D&C Red No. 39.

o-[p-(B,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(8,8'-Dihydroxy-diethyl) aniline, not more than 0.2 percent.

Sulfated ash, not more than 1.5 percent.

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

§ 9.200 D&C Orange No. 3.

Disodium salt of 1-phenylazo-2-naphthol-6,8-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.

Aniline, 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.

§ 9.201 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 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.

NOTE: See note under § 9.130.

§ 9.205 D&C Orange No. 8.

4,5-Dichloro-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.

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

Mixed oxides, not more than 1.0 percent.

Free chlorine, not more than 0.02 percent.

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

Pure dye (as determined by titration with titanium trichloride), 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 9-0-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.

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

§ 9.211 D&C Orange No. 14.

4,5,15-Tribromo-2,7

fluorandiol.

dicarboxy-3,6

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

Sulfated ash, not more than 1.0 per

cent.

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 36.0-40.0 percent.

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

§ 9.212 D&C Orange No. 15.

1,2-Anthraquinonediol.

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

Water-soluble matter, not more than 1.5 percent.

Ether-insoluble matter, not more than 1.0 percent.

Sodium chloride, not more than 1.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined gravimetrically), not less than 95.0 percent. Melting point, not less than 285° C. § 9.213 D&C Orange No. 16.

4,5-Dibromo - 2,7-diiodo - 3,6-fluoran

diol.

Volatile matter (at 135°o C.), no more than 5.0 percent.

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

Ether extracts (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 halogens, not more than 0.05 percent.

Permitted range of organically combined bromine in pure dye, 20.0-23.0 percent.

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 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.

NOTE: See note under § 9.130.

§ 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) - A - 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.

§ 9.243 D&C Blue No. 7.

Monosodium salt of 4-{[4-(N-ethylbenzyl-amino)-phenyl] (5-hydroxy-4

sulfo-2-sulfoniumphenyl)-methylene}(N-ethyl-N-benzyl-A” – cyclohexadieni

mine).

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-Nitrobenzaldehyde, not more than

0.2 percent.

Benzylethylaniline, 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.

§ 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 percent.

2-Amino anthraquinone, not more than 0.2 percent.

Matter extractable by alcoholic HCl, not more than 1.0 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 - anthraquinone.

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

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

· Mixed oxides, not more than 1.0 percent.

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

§ 9.303 Ext D&C Yellow No. 3.

Monosodium salt of 5-hydroxy-3methyl-4-phenylazo-1-p-sulfophenyl

pyrazole.

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.

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

Mixed oxides, not more than 1.0 percent.

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