FD&C YELLOW No. 2 Water insoluble matter, not more than 0.5 percent. Ether extracts, not more than 0.4 percent. Dipotassium salt of 2, 4-dinitro-1 Chlorides and sulfates of sodium, not naphthol-7-sulfonic acid. more than 6.0 percent. Volatile matter (at 135° C.), not more Mixed oxides, not more than 1.0 per- than 10.0 percent. cent. Ether extracts, not more than 0.1 per Subsidiary dyes (as FD&C Green No. cent. 1), not more than 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent. FD&C GREEN NO. 3 SPECIFICATIONS Chlorides and sulfates of potassium, 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 Disodium salt of 4-([4-(N-ethyl-p-with titanium trichloride), not less than sulfobenzylamino) - phenyl]-(4-hydroxy- 85.0 percent. 2-sulfoniumphenyl) - methylene) - [1-Nethyl-(N-p-sulfobenzyl)-▲2 -cyclohexa dienimine]. 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 0.4 percent. Chlorides and sulfates of sodium, not more than 5.0 percent. Mixed oxides, not more than 1.0 percent. Subsidiary dyes, not more than 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent. FD&C YELLOW No. 1 SPECIFICATIONS Disodium salt of 2, 4-dinitro-1-naphthol-7-sulfonic acid. Volatile matter (at 135° C.), not more than 10.0 percent. FD&C YELLOW No. 3 SPECIFICATIONS 1-Phenylazo-2-naphthylamine. Volatile matter (at 80° C.), not more than 0.2 percent. Sulfated ash, not more than 0.3 per cent. Water soluble matter, not more than 0.3 percent. Matter, insoluble in carbon tetrachloride, not more than 0.5 percent. Intermediates, not more than 0.05 per cent. Pure dye (as determined by titration with titanium trichloride), not less than 99.0 percent. Melting point, not less than 99° C. SPECIFICATIONS 1-0-Tolylazo-2-naphthylamine. Volatile matter (at 80° C.), not more Water insoluble matter, not more than than 0.2 percent. 0.2 percent. Sulfated ash, not more than 0.3 per Ether extracts, not more than 0.1 per cent. cent. Water soluble matter, not more than Matter, insoluble in carbon tetrachlo Chlorides and sulfates of sodium, not 0.3 percent. more than 5.0 percent. Mixed oxides, not more than 1.0 per- ride, not more than 0.5 percent. cent. Intermediates, not more than 0.05 per Martius Yellow, not more than 0.03 cent. percent. Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 99.0 percent. Melting point, not less than 120° C. 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 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than Water insoluble matter, not more than 85.0 percent. 0.5 percent. Boiling range of crude pseudo-cumi Ether extracts, not more than 0.3 per- dine, or of pseudo-cumidine obtained by reduction of the dye, 220-245° C. cent. Phenylhydrazine-p-sulfonic acid, not more than 0.1 percent. Chlorides and sulfates of sodium, not more than 6.0 percent. FD&C RED NO. 2 SPECIFICATIONS Trisodium salt of 1-(4-sulfo-1-naph Mixed oxides, not more than 1.0 per- thylazo)-2-naphthol-3,6-disulfonic acid. cent. Volatile matter (at 135° C.), not more Subsidiary dyes, not more than 3.0 than 10.0 percent. percent. Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent. FD&C YELLOW No. 6 SPECIFICATIONS Disodium salt of 1-p-sulfophenylazo2-naphthol-6-sulfonic acid. 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. Chlorides and sulfates of sodium, not more than 5.0 percent. Mixed oxides, not more than 1.0 percent. Subsidiary dyes, not more than 4.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than Water insoluble matter, not more than 85.0 percent. 0.5 percent. Ether extracts, 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. Subsidiary dyes, not more than 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent. FD&C RED NO. 1 SPECIFICATIONS FD&C RED NO. 3 SPECIFICATIONS Disodium salt of 9-o-carboxyphenyl-6hydroxy-2, 4, 5, 7-tetroiodo-3-isoxanthone. Volatile matter (at 135° C.), not more than 12.0 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 2.0 percent. Sodium carbonate, not more than 0.5 Disodium salt of 1-pseudocumylazo-2-percent. naphthol-3,6-disulfonic acid. Sodium iodide, not more than 0.4 per Volatile matter (at 135° C.), not more cent. than 10.0 percent. Mixed oxides, not more than 1.0 per Water insoluble matter, not more than cent. 0.3 percent. Permitted range of organically com Ether extracts, not more than 0.2 per- bined iodine in pure dye, free from water cent. Pseudo-cumidine. not more than 0.2 percent. of crystallization, 56.8 to 58.5 percent. Pure dye (as determined gravimetrically), not less than 85.0 percent. FD&C RED NO. 4 SPECIFICATIONS Disodium salt of 2-(5-sulfo-2, 4-xylylazo)-1-naphthol-4-sulfonic acid. Volatile matter (at 135° C.), not more than 10.0 percent. Water insoluble matter, not more than 0.3 percent. Ether extracts, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 98.0 percent. Melting point, not less than 128.0° C. SPECIFICATIONS Disodium salt of 4-([4-(N-ethyl-psulfobenzylamino) -phenyl] -(2 - sulfoniumphenyl)-methylene)-[1-N-ethyl-N-psulfobenzyl) -A3-cyclohexadienimine] Volatile matter (at 135° C.), not Mixed oxides, not more than 1.0 per- more than 10.0 percent. cent. Water insoluble matter, not more than Mixed oxides, not more than 1.0 than 10.0 percent. percent. Orange II, not more than 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent. Water insoluble matter, not more than 0.5 percent. Ether extracts, not more than 0.5 percent. Chlorides and sulfates of sodium, not more than 7.0 percent. Mixed oxides, not more than 1.0 percent. Lower sulfonated dyes, not more than 5.0 percent. Pure dye (as determined by titration 85.0 percent. with titanium trichloride), not less than FD&C RED NO. 32 SPECIFICATIONS 1-Xylylazo-2-naphthol. Volatile matter (at 100° C.), not more than 0.5 percent. Sulfated ash, not more than 0.3 per cent. percent. 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.* [Regs., May 4, 1939, effective May 9, 1939, as amended Sept. 14, 1939, effective Sept. 16, 1939; 4 F.R. 1935, 3936] NOTE: This section was amended by substituting the words "Ether extracts not more than 0.1 percent" for the words "Ether extracts not more than 0.2 percent," under FD&C YELLOW No. 2, by deleting the words "Chlorides and sulfates of sodium, not more than 0.5 percent," under FD&C ORANGE No. 2, and by adding FD&C RED NO. 32, SPECIFICATIONS, at the end thereof, Sept. 14, 1939, effective Sept. 16, 1939; 4 F.R. 3936. § 135.4 List of straight colors and specifications for their certification for use in drugs and cosmetics. (a) A batch of a straight color listed herein 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 § 135.2 and to the specifications herein set forth for such color. D&C GREEN No. 4 SPECIFICATIONS Calcium salt of 4-([4-(N-ethyl-p-sulfobenzylamino) - phenyl] - (4 - sulfoniumphenyl)methylene) - [1-(N-ethyl-N-psulfobenzyl)-A2 -cyclohexadienimine]. Volatile matter (at 135° C.), not more than 10.0 percent. Water insoluble matter, not more than than 2.0 percent. 1.0 percent. Insoluble matter (alkaline solution), Ether extracts, not more than 0.5 per- not more than 1.0 percent. cent. 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. 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. Pure dye (as determined by titration with titanium trichloride), not less than 96.0 percent. D&C YELLOW No. 8 SPECIFICATIONS Disodium salt 9-o-carboxyphenyl-6hydroxy-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 8.0 percent. D&C RED No. 5 SPECIFICATIONS Disodium salt of 1-xylylazo-2-napthol3, 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. Mixed oxides, not more than 1.0 per- more than 6.0 percent. cent. Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent. 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. Mixed oxides, not more than 1.0 per cent. Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent. Calcium salt of 4-(o-sulfo-p-tolylazo) 3-hydroxy-2-naphthoic acid. Volatile matter (at 135° C.), not more than 8.0 percent. Ether extracts (Isopropyl ether), not more than 0.5 percent. Chlorides and sulfates (as calcium Ether extracts, not more than 0.5 per- salts), not more than 6.0 percent. cent. Oxides of iron and aluminum, not more Quinaldine, not more than 0.2 per- than 1.0 percent. cent. Pure dye (as determined by titration Chlorides and sulfates of sodium, not with titanium trichloride), not less than more than 6.0 percent. 85.0 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 RED No. 8 SPECIFICATIONS Monosodium salt of 1-(4-chloro-osulfo-5-tolylazo) -2-naphthol. |