§ 9.100 Lakes (FD&C).

(a) (1) General. Any lake made by extending on a substratum of alumina. a salt prepared from one of the certified water-soluble straight colors hereinbefore listed in this subpart by combining such color with the basic radical aluminum or calcium.

(2) Specifications.

Prepared from previously certified colors listed in this subpart.

Soluble chlorides and sulfates (as sodium salts), not more than 2.0 percent. Inorganic matter, insoluble in HCl, not more than 0.5 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;

(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 aluminum salt prepared from FD&C Blue No. 1 upon the substratum would be FD&C Blue No. 1-Aluminum Lake.)

Subpart C-Straight Colors and Specifications for Their Certification for Use in Drugs and Cosmetics

§ 9.101 General.

A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use only in 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.

§ 9.103 D&C Green No. 5.

Disodium salt of 1,4-bis(o-sulf-ptoluino)-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.

1,4-Dihydroxy- anthraquinone, more than 0.2 percent.

not

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 75.0 percent.

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 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.

§ 9.106 D&C Green No. 8.

Trisodium salt of 10-hydroxy-3,5,8pyrene-trisulfonic acid.

Volatile matter (at 135° C.), not more than 15.0 percent.

Water-insoluble matter, not more than 0.5 percent.

Chloroform extract, not more than 0.5 percent.

Pyrene, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 20.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as calculated from organically combined sulfur), not less than 65.0 percent.

§ 9.130 D&C Yellow No. 7.

3,6-Fluorandiol.

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

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

§ 9.133

D&C Yellow No. 10.

Disodium salt of disulfonic acid of 2(2-quinolyl)-1,3-indandione.

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.

Quinaldine, 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 calculated from organically combined nitrogen), not less than 82.0 percent.

§ 9.134 D&C Yellow No. 11.

2-(2-Quinolyl)-1,3-indandione. Volatile matter (at 135° C.), not more than 1.0 percent.

Sulfated ash, not more than 1.0 per

cent.

Matter insoluble in alcohol, not more than 0.5 percent.

Quinaldine, 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 235° C. § 9.150 D&C Red No. 5.

Disodium salt of 1-xylylazo-2-naphthol-3,6-disulfonic acid.

Monosodium salt of 4-(o-sulfo-p-tolylazo)-3-hydroxy-2-naphthoic acid.

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

Water-insoluble matter, not more than 1.0 percent.

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

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.

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.

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.

§ 9.162 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.

§ 9.163 D&C Red No. 18.

1-Xylylazoxylylazo-2-naphthol. Volatile matter (at 100° C.), not more than 2.0 percent.

Sulfated ash, not more than 2.0 percent.

Water-soluble matter, not more than 0.5 percent.

Matter, insoluble in carbon tetrachloride, not more than 1.0 percent.

Chlorides and sulfates of sodium, not more than 1.0 percent.

Amino-azoxylene, not more than 0.2

percent.

Xylidine, 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 95.0 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,

than 0.2 percent.

not more

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.

Insoluable 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.

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 bromine, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye, 44.5-48.5 percent.

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

§ 9.169 D&C Red No. 24.

2,4,5,7-Tetrachloro-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, 28.0-32.0 percent.

Pure dye (as determined gravimetrically), not less than 90.0 percent. § 9.172 D&C Red No. 27.

2,4,5,7-Tetrabromo-12,13,14,15-tetra

chloro-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 halogens, not more than 0.02 percent.

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-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.

§ 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.

§ 9.180 D&C Red No. 35.

1-(o-Nitro-p-tolylazo)-2-naphthol.

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

Sulfated ash, not more than 1.5 percent.

Matter insoluble in toluene, not more than 1.5 percent.