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

FD&C VIOLET NO. 1

SPECIFICATIONS

Monosodium salt of 4-{[4-(N-ethyl-psulfobenzylamino) - phenyl]-[4-(N-ethyl-psulfoniumbenzylamino) - phenyl]-methylene}- (N,N-dimethyl-2,5- cyclohexadienimine).

Volatile matter (at 135° C.), not more than 8.0 percent.

Water-insoluble matter, not more than 0.3

percent.

Ether extracts, not more than 0.4 percent. p-Dimethylaminobenzoic acid, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 4.0 percent.

Mixed oxides, not more than 1.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

The sum of the volatile matter, chlorides and sulfates of sodium, pure dye, and leuco base of the dye, not less than 95.0 percent.

LAKES

Any lake made by extending on a substratum of alumina, a salt prepared from one of the water soluble straight colors herein before listed in this paragraph by combining such color with the basic radicle aluminum or calcium.

SPECIFICATIONS

Ether extracts, not more than 0.3 percent. Soluble chlorides and sulfates (as sodium salts), not more than 2.0 percent.

Inorganic matter, insoluble in HCl, not more than 0.5 percent.

Intermediates, not more than 0.1 percent.

(b) Each lake made as prescribed under the caption "Lakes" 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 radicle 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 Orange No. 1 upon the substratum would be FD&C Orange No. 1-Aluminum Lake.)

(c) No lake listed in paragraph (a) of this section shall be certified for any use in food except external application to shell eggs.

§ 9.4 List of straight colors and specifications for their certification for use in drugs and cosmetics. (a) A batch of a straight color listed in this section 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 section for such color.

D&C GREEN NO. 4

SPECIFICATIONS

Calcium salt of 4-{[4-(N-ethyl-p-sulfobenzylamino) -phenyl]-(4-sulfonium - phenyl)methylene)-[1-(N-ethyl-N-p-sulfobenzyl)

A2.5-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 (as calcium salts), not more than 5.0 percent.

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

Subsidiary dyes (as FD&C Green No. 1), not more than 5.0 percent.

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

D&C GREEN No. 5

SPECIFICATIONS

Disodium salt of 1,4-bis (o-sulfo-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. 1,4-Dihydroxy-anthraquinone, 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 75.0 percent.

D&C GREEN No. 6

SPECIFICATIONS

1,4-bis-(p-Toluino) -anthraquinone. Volatile matter (at 135° C.), not more than 2.0 percent.

Sulfated ash, not more than 1.0 percent. Water soluble matter, not more than 0.3 percent.

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

Intermediates, not more than 0.5 percent. Pure dye (as determined by titration with titanium trichloride), not less than 96.0 percent.

Melting point, not less than 210° C.

D&C GREEN No. 7

SPECIFICATIONS

Monosodium salt of 4-{[4-(N-ethyl-p-sulfobenzylamino) - phenyl]-(o-chlorophenyl)

methylene)-1-(N-ethyl-N-p-sulfonium-ben

zyl-2-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 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.

D&C YELLOW No. 9

SPECIFICATIONS

Dipotassium salt of 9-o-carboxyphenyl6-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 potassium, 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.

D&C YELLOW NO. 10

SPECIFICATIONS

Disodium salt of disulfonic acid of 2-(2quinolyl)-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.

D&C YELLOW NO. 11

SPECIFICATIONS

2-(2-Quinolyl)-1,3-indandione.

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

Sulfated ash, not more than 1.0 percent. 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.

D&C RED No. 5

SPECIFICATIONS

Disodium salt of 1-xylylazo-2-naphthol3,6-disulfonic acid.

Volatile matter (at 135° C.), not more than 12.0 percent.

Water insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Xylidine, 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.

D&C RED NO. 6 SPECIFICATIONS

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

Barium salt of 1-(4-chloro-o-sulfo-5-tolylazo)-2-naphthol.

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

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

Lake Red C Amine, not more than 0.2 percent.

beta-Naphthol, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 6.0 percent.

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

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

D&C RED NO. 10

SPECIFICATIONS

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

Volatile matter (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. beta-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.

D&C RED No. 11

SPECIFICATIONS

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. beta-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.

D&C RED NO. 12

SPECIFICATIONS

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. beta-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.

D&C RED No. 13

SPECIFICATIONS

Strontium 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. beta-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.

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.

D&C RED NO. 22

SPECIFICATIONS

Disodium salt of 2,4,5,7-tetrabromo-9-0carboxyphenyl-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 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.

D&C RED NO. 23

SPECIFICATIONS

Dipotassium salt of 2,4,5,7-tetrabromo-9o-carboxyphenyl-6-hydroxy-3-isoxanthone. Volatile matter (at 135° C.), not more than 15.0 percent.

Water insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent. Chlorides and sulfates of potassium, 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 (free from water or alcohol of crystallization), 42.0-46.0 percent. Pure dye (as determined gravimetrically). not less than 80.0 percent.

D&C RED No. 24

SPECIFICATIONS

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), nor 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.

D&C RED NO. 25

SPECIFICATIONS

Disodium salt of 9-o-carboxyphenyl-2,4, 5,7-tetrachloro-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 chlorine, not more than 0.02 percent. Permitted range of organically combined chlorine in pure dye, 26.0-29.5 percent. Pure dye (as determined gravimetrically), not less than 85.0 percent.

D&C RED No. 26

SPECIFICATIONS

Dipotassium salt of 9-o-carboxyphenyl-2, 4,5,7-tetrachloro-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 potassium, not more than 5.0 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, 24.5-27.5 percent. Pure dye (as determined gravimetrically), not less than 85.0 percent.

D&C RED No. 27

SPECIFICATIONS

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

Sodium chloride, not more than 3.0 per

cent.

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.

D&C RED No. 28

SPECIFICATIONS

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.