 |
|
 |
|
 |
 |
|
(a) Identity. (1) For ingested drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of §74.101(a)(1). (2) For externally applied drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of §74.2101(a). (3) Color additive mixtures for drug use made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. (1) The color additive FD&C Blue No. 1 for use in coloring drugs generally shall conform in specifications to the requirements of §74.101(b). (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of §82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used for coloring drugs, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice, subject to the restrictions on the use of color additives in §70.5(b) and (c) of this chapter. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42565, Sept. 28, 1982, as amended at 59 FR 7638, Feb. 16, 1994] § 74.1102 FD&C Blue No. 2.(a) Identity. (1) The color additive FD&C Blue No. 2 shall conform in identity to the requirements of §74.102(a)(1). (2) Color additive mixtures for use in ingested drugs made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) The color additive FD&C Blue No. 2 for use in coloring ingested drugs shall conform to the specifications in §74.102(b). (c) The color additive FD&C Blue No. 2 may be safely used for coloring ingested drugs in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 2 shall be certified in accordance with regulations in part 80 of this chapter. [48 FR 5260, Feb. 4, 1983, as amended at 49 FR 10090, Mar. 19, 1984; 64 FR 48290, Sept. 3, 1999] § 74.1104 D&C Blue No. 4.(a) Identity. (1) The color additive D&C Blue No. 4 is principally the diammonium salt of ethyl[4-[ p [ethyl( m- sulfobenzyl)ami-no]-α-( o- sulfophenyl)benzylidene]-2,5-cyclo-hexadien-1-ylidene] ( m- sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric diammonium salts of ethyl [4-[ p- [ethyl( p- sulfobenzyl) amino]-α-( o- sulfophenyl) benzylidene]-2,5-cyclohexadien - 1-ylidene]( p- sulfobenzyl) ammonium hydroxide inner salt and ethyl[4-[ p- [ethyl ( o- sulfobenzyl)amino]-α-( o- sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] ( o- sulfobenzyl) ammonium hydroxide inner salt. (2) Color additive mixtures for use in externally applied drugs made with D&C Blue No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Blue No. 4 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o-, m , and p- sulfobenzaldehydes, ammonium salt, not more than 1.5 percent. N-ethyl, N-( m- sulfobenzyl) sulfanilic acid ammonium salt, not more than 0.3 percent. Subsidiary colors, not more than 6 percent. Chromium (as Cr), not more than 50 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. D&C Blue No. 4 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Blue No. 4 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1109 D&C Blue No. 9.(a) Identity. The color additive D&C Blue No. 9 is principally 7,16-dichloro-6,15 - dihydro - 5,9,14,18 - anthrazine-tetrone. (b) Specifications. D&C Blue No. 9 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Volatile matter (at 135 °C.), not more than 3 percent. Matter extractable by alcoholic HCl (0.1 ml of concentrated hydrochloric acid per 50 ml of 95 percent ethyl alcohol), not more than 1 percent. 2-Amino anthraquinone, not more than 0.2 percent. Organically combined chlorine in pure dye, 13.0–14.8 percent. Lead (as Pb), not more than 20 p/m. Arsenic (as As), not more than 3 p/m. Total color, not less than 97 percent. (c) Uses and restrictions. D&C Blue No. 9 may be safely used for coloring cotton and silk surgical sutures, including sutures for ophthalmic use, subject to the following restrictions: (1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980). (2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture. (3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue. (4) If the suture is a new drug, a new-drug application approved pursuant to section 505 of the act is in effect for it. (d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Blue No. 9 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 1993] § 74.1203 FD&C Green No. 3.(a) Identity and specifications. (1) The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of §74.203(a)(1) and (b). (2) Color additive mixtures for drug use made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Uses and restrictions. The color additive FD&C Green No. 3 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (d) Certification. All batches of FD&C Green No. 3 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 52144, Nov. 19, 1982] § 74.1205 D&C Green No. 5.(a) Identity. (1) The color additive D&C Green No. 5 is principally the disodium salt of 2,2′-[(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl)diimino]bis-[5-methylbenzenesulfonic acid] (CAS Reg. No. 4403–90–1). (2) Color additive mixtures for use in drugs made with D&C Green No. 5 may contain only those diluents that are suitable and those that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs. (b) Specifications. (1) D&C Green No. 5 for use in coloring surgical sutures shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent. Water insoluble matter, not more than 0.2 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 2-Amino- m -toluenesulfonic acid, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 80 percent. (2) D&C Green No. 5 for use in coloring drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent. Water-insoluble matter, not more than 0.2 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. Sulfonated toluidines, total not more than 0.2 percent. p -Toluidine, not more than 0.0015 percent. Sum of monosulfonated D&C Green No. 6 and Ext. D&C Violet No. 2, not more than 3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 80 percent. (c) Use and restrictions. (1) D&C Green No. 5 may be safely used to color nylon 66 (the copolymer of adipic acid and hexamethylenediamine) and/or nylon 6[poly-( e -caprolactam)]nonabsorbable surgical sutures for use in general surgery, subject to the following restrictions: (i) The quantity of color additive does not exceed 0.6 percent by weight of the suture. (ii) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue. (iii) If the suture is a new drug, an approved new drug application, under section 505 of the act, is in effect for it. (2) D&C Green No. 5 may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Green No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 24284, June 4, 1982; 47 FR 27551, June 25, 1982, as amended at 59 FR 40805, Aug. 10, 1994] § 74.1206 D&C Green No. 6.(a) Identity. The color additive D&C Green No. 6 is 1,4-bis[(4-methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128–80–3). (b) Specifications. The color additive D&C Green No. 6 for use in coloring externally applied drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Volatile matter (at 135 °C), not more than 2.0 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 1.5 percent. p -Toluidine, not more than 0.1 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 5.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96.0 percent. (c) Uses and restrictions. The color additive D&C Green No. 6 may be safely used for coloring externally applied drugs in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Green No. 6 shall be certified in accordance with regulations promulgated under part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr.2, 1982; 47 FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986] § 74.1208 D&C Green No. 8.(a) Identity. (1) The color additive D&C Green No. 8 is principally the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid. (2) Color additive mixtures for use in externally applied drugs made with D&C Green No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Green No. 8 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practices: Volatile matter (at 135 °C), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Chlorides and sulfates (calculated as sodium salt), not more than 20 percent. The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 percent. The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 1 percent. Pyrene, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 65 percent. (c) Uses and restrictions. D&C Green No. 8 may be safely used in externally applied drugs in amounts not exceeding 0.01 percent by weight of the finished product. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Green No. 8 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1254 D&C Orange No. 4.(a) Identity. (1) the color additive D&C Orange No. 4 is principally the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid. (2) Color additive mixtures for use in externally applied drugs made with D&C Orange No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Orange No. 4 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 2-Naphthol, not more than 0.4 percent. Sulfanilic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 3 percent. 4,4′-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (c) Uses and restrictions. D&C Orange No. 4 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Orange No. 4 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, 1981] § 74.1255 D&C Orange No. 5.(a) Identity. (1) the color additive D&C Orange No. 5 is a mixture consisting principally the sodium salt of 4′,5′-dibromofluorescein (CAS Reg. No. 596–03–2) and 2′,4′,5′-tribromofluorescein (CAS Reg. No. 25709–83–5) and 2′,4′,5′,7′-tetrabromofluorescein (CAS Reg. No. 15086–94–9). D&C Orange No. 5 is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. The fluorescein is isolated and partially purified prior to bromination. (2) Color additive mixtures for drug use made with D&C Orange No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs. (b) Specifications. D&C Orange No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice. 4′,5′-dibromofluorescein, not less than 50 percent and not more than 65 percent. 2′,4′,5′-tribromofluorescein, not less than 30 percent and not more than 40 percent. 2′,4′,5′,7′-tetrabromofluorescein, not more than 10 percent. Sum of 2′,4′-dibromofluorescein and 2′,5′-dibromofluorescein, not more than 2 percent. 4′–Bromofluorescein, not more than 2 percent. Fluorescein, not more than 1 percent. Phthalic acid, not more than 1 percent. 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Brominated resorcinol, not more than 0.4 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. D&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested drugs in amounts consistent with current good manufacturing practice. D&C Orange No. 5 may be safely used in externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Orange No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 44635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984] § 74.1260 D&C Orange No. 10.(a) Identity. (1) The color additive D&C Orange No. 10 is a mixture consisting principally of 4′,5′-diiodofluorescein, 2′,4′,5′-triiodofluorescein, and 2′,4′,5′,7′-tetraiodofluorescein. (2) Color additive mixtures for drug use made with D&C Orange No. 10 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Orange No. 10 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, not more than 0.5 percent. Fluorescein, not more than 1 percent. 4′-Iodofluorescein, not more than 3 percent. 2′,4′-Diiodofluorescein and 2′,5′-diiodofluorescein, not more than 2 percent. 2′,4′,5′-Triiodofluorescein, not more than 35 percent. 2′,4′,5′,7′-Tetraiodofluorescein, not more than 10 percent. 4′,5′-Diiodofluorescein, not less than 60 percent and not more than 95 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 92 percent. (c) Uses and restrictions. D&C Orange No. 10 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Orange No. 10 shall be certified in accordance with regulations in part 80 of this chapter. [46 FR 18953, Mar. 27, 1981] § 74.1261 D&C Orange No. 11.(a) Identity. (1) The color additive D&C Orange No. 11 is a mixture consisting principally of the disodium salts of 4′,5′-diiodofluorescein, 2′,4′,5′-triiodofluorescein and 2′,4′,5′,7′-tetraiodofluorescein. (2) Color additive mixtures for drug use made with D&C Orange No. 11 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. The color additive D&C Orange No. 11 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Water-insoluble matter, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, sodium salt, not more than 0.5 percent. Fluorescein, disodium salt, not more than 1 percent. 4′-Iodofluorescein, disodium salt, not more than 3 percent. 2′,4′-Diiodofluorescein and 2′,5′-diiodofluorescein, not more than 2 percent. 2′,4′,5′-Triiodofluorescein, not more than 35 percent. 2′,4′,5′,7′-Tetraiodofluorescein, disodium salt, not more than 10 percent. 4′,5′-Diiodofluorescein, disodium salt, not less than 60 percent and not more than 95 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 92 percent. (c) Uses and restrictions. D&C Orange No. 11 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter. [46 FR 18953, Mar. 27, 1981] § 74.1303 FD&C Red No. 3.(a) Identity and specifications. (1) The color additive FD&C Red No. 3 shall conform in identity and specifications to the requirements of §74.303(a)(1) and (b). (2) Color additive mixtures for ingested drug used made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring ingested drugs in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1304 FD&C Red No. 4.(a) Identity. (1) The color additive FD&C Red No. 4 is principally the disodium salt of 3-[(2,4-dimethyl-5-sulfophenyl)azo] -4-hydroxy-1-naphthalenesulfonic acid. (2) Color additive mixtures for use in externally applied drugs made with FD&C Red No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. FD&C Red No. 4 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than 0.2 percent. 4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (c) Uses and restrictions. FD&C Red No. 4 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of FD&C Red No. 4 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1306 D&C Red No. 6.(a) Identity. (1) The color additive D&C Red No. 6 is principally the disodium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-naphthalenecarboxylic acid (CAS Reg. No. 5858–81–1). To manufacture the additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid. The resulting dye precipitates as the disodium salt. (2) Color additive mixtures for drug use made with D&C Red No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. The color additive D&C Red No. 6 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. Ether-soluble matter, passes test entitled “The Procedure for Determining Ether-Soluble Material in D&C Red Nos. 6 and 7,” which is an Appendix A to part 74. 2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, sodium salt, not more than 0.5 percent. p- Toluidine, not more than 15 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. The color additive D&C Red No. 6 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 57687, Dec. 28, 1982] § 74.1307 D&C Red No. 7.(a) Identity. (1) The color additive D&C Red No. 7 is principally the calcium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-naphthalenecarboxylic acid (CAS Reg. No. 5281–04–9). To manufacture the additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid and the resulting dye converted to the calcium salt with calcium chloride. (2) Color additive mixtures for drug use made with D&C Red No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. The color additive D&C Red No. 7 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. Ether-soluble matter, passes test entitled “The Procedure for Determining Ether-soluble Material in D&C Red Nos. 6 and 7,” which is an Appendix A to part 74. 2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium salt, not more than 0.5 percent. p -Toluidine, not more than 15 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. The color additive D&C Red No. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 7 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 57687, Dec. 28, 1982] § 74.1317 D&C Red No. 17.(a) Identity. (1) The color additive D&C Red No. 17 is principally 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol. (2) Color additive mixtures for drug use made with D&C Red No. 17 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Red No. 17 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 135 °C), not more than 5 percent. Matter insoluble in both toluene and water (color additive mixed in toluene and the resultant residue isolated and mixed with water to obtain the matter insoluble in both toluene and water), not more than 0.5 percent. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Aniline, not more than 0.2 percent. 4-Aminoazobenzene, not more than 0.1 percent. 2-Naphthol, not more than 0.2 percent. 1-(Phenylazo)-2-naphthol, not more than 3 percent. 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. D&C Red No. 17 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 17 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 42 FR 27225, May 27, 1977] § 74.1321 D&C Red No. 21.(a) Identity. (1) The color additive D&C Red No. 21 is principally 2′,4′,5′,7′-tetrabromofluorescein (CAS Reg. No. 15086–94–9), and may contain smaller amounts of 2′,4′,5′-tribromofluorescein (CAS Reg. No. 25709–83–5) and 2′,4′,7′-tribromofluorescein (CAS Reg. No. 25709–84–6). The color additive is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. The fluorescein is isolated and partially purified prior to bromination. (2) Color additive mixtures for drug use made with D&C Red No. 21 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. The color additive D&C Red No. 21 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135°C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent. Brominated resorcinol, not more than 0.4 percent. Fluorescein, not more than 0.2 percent. Sum of mono- and dibromofluoresceins, not more than 2 percent. Tribromofluoresceins, not more than 11 percent. 2′,4′,5′,7′-Tetrabromofluorescein, not less than 87 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. The color additive D&C Red No. 21 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 21 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982] § 74.1322 D&C Red No. 22.(a) Identity. (1) The color additive D&C Red No. 22 is principally the disodium salt of 2′,4′,5′7′-tetrabromofluorescein (CAS Reg. No. 17372–87–1) and may contain smaller amounts of the disodium salts of 2′,4′,5′-tribromofluorescein and 2′,4′,7′-tribromofluorescein. The color additive is manufactured by alkaline hydrolysis of 2′,4′,5′,7′-tetrabromofluorescein. 2′,4′,5′,7′-Tetrabromofluorescein is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. Fluorescein is isolated and partially purified prior to bromination. (2) Color additive mixtures for drug use made with Red No. 22 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. The color additive D&C Red No. 22 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135°C) and halides and sulfates (calculated as soduim salts), not more than 10 percent. Water-insoluble matter not more than 0.5 percent. Disodium salt of phthalic acid, not more than 1 percent. Sodium salt of 2-(3,5-Dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.5 percent. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent. Brominated resorcinol, not more than 0.4 percent. Sum of disodium salts of mono- and dibromofluoresceins, not more than 2 percent. Sum of disodium salts of tribromofluoresceins, not more than 25 percent. Disodium salt of 2′,4′,5′,7′-Tetrabromofluorescein, not less than 72 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. The color additive D&C Red No. 22 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 22 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982] § 74.1327 D&C Red No. 27.(a) Identity. (1) The color additive D&C Red No. 27 is principally 2′,4′,5′,7′-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 13473-26-2). The color additive is manufactured by brominating 4,5,6,7-tetrachlorofluorescein with elemental bromine. The 4,5,6,7-tetrachlorofluorescein is manufactured by the acid condensation of resorcinol and tetrachlorophthalic acid or its anhydride. The 4,5,6,7-tetrachlorofluorescein is isolated and partially purified prior to bromination. (2) Color additive mixtures for drug use made with D&C Red No. 27 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. D&C Red No. 27 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.7 percent. 2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent. Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. D&C Red No. 27 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 27 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982] § 74.1328 D&C Red No. 28.(a) Identity. (1) The color additive D&C Red No. 28 is principally the disodium salt of 2′,4′,5′,7′-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 18472–87–2) formed by alkaline hydrolysis of the parent tetrabromotetrachlorofluorescein. (2) Color additive mixtures for drug use made with D&C Red No. 28 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. D&C Red No. 28 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 15 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.7 percent. 2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent. Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. D&C Red No. 28 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 28 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982] § 74.1330 D&C Red No. 30.(a) Identity. (1) The color additive D&C Red No. 30 is principally 6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[ b ]thien-2(3 H )-ylidene)-4-methyl-benzo[ b ]thiophen-3(2 H )-one (CAS Reg. No. 2379–74–0). (2) Color additive mixtures for drug use made with D&C Red No. 30 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. D&C Red No. 30 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Volatile matter (at 135 °C), not more than 5 percent. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Matter soluble in acetone, not more than 5 percent. Total color, not less than 90 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. D&C Red No. 30 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 30 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 22510, May 25, 1982] § 74.1331 D&C Red No. 31.(a) Identity. (1) The color additive D&C Red No. 31 is principally the calcium salt of 3-hydroxy-4-(phenylazo)-2-naphthalenecarboxylic acid. (2) Color additive mixtures for drug use made with D&C Red No. 31 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Red No. 31 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. Aniline, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. D&C Red No. 31 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 31 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1333 D&C Red No. 33.(a) Identity. (1) The color additive D&C Red No. 33 is principally the disodium salt of 5-amino-4-hydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid (CAS Reg. No. 3567–66–6). To manufacture the additive, the product obtained from the nitrous acid diazotization of aniline is coupled with 4-hydroxy-5-amino-2,7-naphthalenedisulfonic acid in an alkaline aqueous medium. The color additive is isolated as the sodium salt. (2) Color additive mixtures for drug use made with D&C Red No. 33 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. D&C Red No. 33 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practices: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.3 percent. 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not more than 0.3 percent. 4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt, not more than 3.0 percent. Aniline, not more than 25 parts per million. 4-Aminoazobenzene, not more than 100 parts per billion. 1,3-Diphenyltriazene, not more than 125 parts per billion. 4-Aminobiphenyl, not more than 275 parts per billion. Azobenzene, not more than 1 part per million. Benzidine, not more than 20 parts per billion. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 82 percent. (c) Uses and restrictions. The color additive D&C Red. No 33 may be safely used for coloring ingested drugs, other than mouthwashes and dentifrices, in amounts not to exceed 0.75 milligram per daily dose of the drug. D&C Red No. 33 may be safely used for coloring externally applied drugs, mouthwashes, and dentifrices in amounts consistent with current good manufacturing practice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 33 shall be certified in accordance with regulations in part 80 of this chapter. [53 FR 33120, Aug. 30, 1988] § 74.1334 D&C Red No. 34.(a) Identity. (1) The color additive D&C Red No. 34 is principally the calcium salt of 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalene-carboxylic acid. (2) Color additive mixtures for drug use made with D&C Red No. 34 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Red No. 34 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated at sodium salts), not more than 15 percent. 2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, not more than 0.4 percent. Subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color not less than 85 percent. (c) Uses and restrictions. The color additive D&C Red No. 34 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 34 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1336 D&C Red No. 36.(a) Identity. (1) The color additive D&C Red No. 36 is 1-[(2-chloro-4-nitrophenyl)azo]-2-naphthalenol (CAS Reg. No. 2814–77–9). The color additive is manufactured by diazotization of 2-chloro-4-nitrobenzenamine in acid medium and coupling with 2-naphthalenol in acid medium. (2) Color additive mixtures for drug use made with D&C Red No. 36 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. D&C Red No. 36 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Volatile matter at 135 °C (275 °F), not more than 1.5 percent. Matter insoluble in toluene, not more than 1.5 percent. 2-Chloro-4-nitrobenzenamine, not more than 0.3 percent. 2-Naphthalenol, not more than 1 percent. 2,4-Dinitrobenzenamine, not more than 0.02 percent. 1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent. 4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5 percent. 1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent. 1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 95 percent. (c) Uses and restrictions. The color additive D&C Red No. 36 may be safely used for coloring ingested drugs, other than mouthwashes and dentifrices, in amounts not to exceed 1.7 milligrams per daily dose of the drug for drugs that are taken continuously only for less than 1 year. For drugs taken continuously for longer than 1 year, the color additive shall not be used in amounts to exceed 1.0 milligram per daily dose of the drug. D&C Red No. 36 may be safely used for coloring externally applied drugs in amounts consistent with current good manufacturing practice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 36 shall be certified in accordance with regulations in part 80 of this chapter. [53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept. 12, 1988, as amended at 53 FR 52130, Dec. 27, 1988] § 74.1339 D&C Red No. 39.(a) Identity. (1) The color additive D&C Red No. 39 is o- [ p (β,β′-dihydroxy-diethylamino)-phenylazo]-benzoic acid. (2) Color additive mixtures made with D&C Red No. 39 may contain the following diluents: Water, acetone, isopropyl alcohol, and specially denatured alcohols used in accordance with 26 CFR part 212. (b) Specifications. D&C Red No. 39 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 100 °C.), not more than 2.0 percent. Matter insoluble in acetone, not more than 1.0 percent. Anthranilic acid, not more than 0.2 percent. N,N- (β,β′-Dihydroxy-diethyl) aniline, not more than 0.2 percent. Subsidiary colors, not more than 3.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 95.0 percent. (c) Uses and restrictions. The color additive D&C Red No. 39 may be safely used for the coloring of quaternary ammonium type germicidal solutions intended for external application only, and subject to the further restriction that the quantity of the color additive does not exceed 0.1 percent by weight of the finished drug product. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Red No. 39 shall be certified in accordance with regulations promulgated under part 80 of this chapter. § 74.1340 FD&C Red No. 40.(a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of §74.340(a)(1) and (b). (2) Color additive mixtures for drug use made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (3) The listing of this color additive includes lakes prepared as described in §§82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by §§82.51 or 82.1051 of this chapter.) (b) Uses and restrictions. (1) FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring drugs, including those intended for use in the area of the eye, subject to the restrictions on the use of color additives in §70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (2) Other lakes of FD&C Red No. 40 may be safely used in coloring drugs, subject to the restrictions on the use of color additives in §70.5 of this chapter, in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive and any lakes or mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regulations, in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994] § 74.1602 D&C Violet No. 2.(a) Identity. (1) The color additive D&C Violet No. 2 is principally 1-hydroxy -4-[(4-methylphenyl)amino]-9,10-anthracenedione. (2) Color additive mixtures for use in externally applied drugs made with D&C Violet No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Violet No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities can be avoided by good manufacturing practice: Volatile matter (at 135 °C.), not more than 2.0 percent. Matter insoluble in both carbon tetrachloride and water, not more than 0.5 percent. p- Toluidine, not more than 0.2 percent. 1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent. Subsidiary colors, not more than 1.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 96.0 percent. (c) Uses and restrictions. The color additive D&C Violet No. 2 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 45 FR 62978, Sept. 23, 1980; 55 FR 18868, May 7, 1990] § 74.1705 FD&C Yellow No. 5.(a) Identity and specifications. (1) The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of §74.705 (a)(1) and (b). (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of §82.51 of this chapter. (3) Color additive mixtures for drug use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, when prepared in accordance with §82.51 of this chapter. (c) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter. (2) The label of OTC and prescription drug products intended for human use administered orally, nasally, rectally, or vaginally, or for use in the area of the eye, containing FD&C Yellow No. 5 shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive using the names FD&C Yellow No. 5 and tartrazine. The label shall bear a statement such as “Contains FD&C Yellow No. 5 (tartrazine) as a color additive” or “Contains color additives including FD&C Yellow No. 5 (tartrazine).” The labels of certain drug products subject to this labeling requirement that are also cosmetics, such as: antibacterial mouthwashes and fluoride toothpastes, need not comply with this requirement provided they comply with the requirements of §701.3 of this chapter. (3) For prescription drugs for human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by §201.100(d) of this chapter shall, in addition to the label statement required under paragraph (c)(2) of this section, bear the warning statement “This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions” section of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 29, 1994] § 74.1706 FD&C Yellow No. 6.(a) Identity and specifications. (1) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of §74.706(a)(1) and (b). (2) Color additive mixtures for drug use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter. (2) [Reserved] (d) Certification. All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988] § 74.1707 D&C Yellow No. 7.(a) Identity. (1) The color additive D&C Yellow No. 7 is principally fluorescein. (2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Yellow No. 7 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 6 percent. Matter insoluble in alkaline water, not more than 0.5 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-2,4-(Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 94 percent. (c) Uses and restrictions. D&C Yellow No. 7 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1707a Ext. D&C Yellow No. 7.(a) Identity. (1) The color additive Ext. D&C Yellow No. 7 is principally the disodium salt of 8-hydroxy-5,7-di-nitro-2-naphthalenesulfonic acid. (2) Color additive mixtures for drug use made with Ext. D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Ext. D&C Yellow No. 7 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. 1-Naphthol, not more than 0.2 percent. 2,4-Dinitro-1-naphthol, not more than 0.03 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. Ext. D&C Yellow No. 7 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of Ext. D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1708 D&C Yellow No. 8.(a) Identity. (1) The color additive D&C Yellow No. 8 is principally the disodium salt of fluorescein. (2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Yellow No. 8 shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in alkaline water, not more than 0.3 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. D&C Yellow No. 8 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1710 D&C Yellow No. 10.(a) Identity. (1) The color additive D&C Yellow No. 10 is a mixture of the sodium salts of the mono- and disulfonic acids of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione consisting principally of the sodium salts of 2-(2,3-dihydro-1,3-dioxo-1 H -indene-2-yl)-6-quinolinesulfonic acid and 2-(2,3-dihydro-1,3-dioxo-1 H -indene-2-yl)-8-quinolinesulfonic acid with lesser amounts of the disodium salts of the disulfonic acids of 2-(2-quinolinyl)-1 H -indene-1,3(2 H )-dione (CAS Reg. No. 8004–92–0). D&C Yellow No. 10 is manufactured by condensing quinaldine with phthalic anhydride to give the unsulfonated dye, which is then sulfonated with oleum. (2) Color additive mixtures made with D&C Yellow No. 10 for drug use may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. The color additive D&C Yellow No. 10 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in both water and chloroform, not more than 0.2 percent. Total sulfonated quinaldines, sodium salts, not more than 0.2 percent. Total sulfonated phthalic acids, sodium salts, not more than 0.2 percent. 2-(2-Quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 4 parts per million. Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not less than 75 percent. Sum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 15 percent. 2-(2,3-Dihydro-1,3-dioxo-1 H -indene-2-yl)-6, 8-quinolinedisulfonic acid, disodium salt, not more than 3 percent. Diethyl ether soluble matter other than that specified, not more than 2 parts per million, using added 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione for calibration. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. The color additive D&C Yellow No. 10 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter. [48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984] § 74.1711 D&C Yellow No. 11.(a) Identity. (1) The color additive D&C Yellow No. 11 is principally 2-(2-quinolyl)-1,3-indandione. (2) Color additive mixtures, for drug use made with D&C Yellow No. 11 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Yellow No. 11 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 135 °C), not more than 1 percent. Ethyl alcohol-insoluble matter, not more than 0.4 percent. Phthalic acid, not more than 0.3 percent. Quinaldine, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96 percent. (c) Uses and restrictions. D&C Yellow No. 11 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 11 shall be certified in accordance with regulations in part 80 of this chapter. Browse Previous | Browse Next
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
