Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&mc=true&n=pt21.1.74&r=PART&ty=HTML
Timestamp: 2019-12-15 22:23:55
Document Index: 774681605

Matched Legal Cases: ['art 74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§74', '§70', '§74', '§74', '§74', '§70', '§74', '§70', '§74', '§82', '§82', '§70', '§70', '§70', '§74']

Title 21 → Chapter I → Subchapter A → Part 74
§74.1101 FD&C Blue No. 1
§74.1102 FD&C Blue No. 2.
§74.1104 D&C Blue No. 4.
§74.1109 D&C Blue No. 9.
§74.1203 FD&C Green No. 3.
§74.1205 D&C Green No. 5.
§74.1206 D&C Green No. 6.
§74.1254 D&C Orange No. 4.
§74.1255 D&C Orange No. 5.
§74.1260 D&C Orange No. 10.
§74.1303 FD&C Red No. 3.
§74.1304 FD&C Red No. 4.
§74.1306 D&C Red No. 6.
§74.1307 D&C Red No. 7.
§74.1327 D&C Red No. 27.
§74.1328 D&C Red No. 28.
§74.1330 D&C Red No. 30.
§74.1333 D&C Red No. 33.
§74.1334 D&C Red No. 34.
§74.1336 D&C Red No. 36.
§74.1339 D&C Red No. 39.
§74.1340 FD&C Red No. 40.
§74.1602 D&C Violet No. 2.
§74.1706 FD&C Yellow No. 6.
§74.1707a Ext. D&C Yellow No. 7.
§74.1708 D&C Yellow No. 8.
§74.1710 D&C Yellow No. 10.
§74.1711 D&C Yellow No. 11.
(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).
(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 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.
(a) Identity. (1) The color additive FD&C Blue No. 2 shall conform in identity to the requirements of §74.102(a)(1).
(b) The color additive FD&C Blue No. 2 for use in coloring ingested drugs shall conform to the specifications in §74.102(b).
(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.
(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).
(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.
(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).
Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent.
2-Amino-m-toluenesulfonic acid, not more than 0.2 percent.
p-Toluidine, not more than 0.0015 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:
Volatile matter (at 135 °C), not more than 2.0 percent.
p-Toluidine, not more than 0.1 percent.
(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.
(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-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, not more than 0.5 percent.
4′-Iodofluorescein, not more than 3 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.
(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).
Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.
p-Toluidine, not more than 15 parts per million.
(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.
(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.
Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 15 percent.
(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(3H)-ylidene)-4-methyl-benzo[b]thiophen-3(2H)-one (CAS Reg. No. 2379-74-0).
Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent.
Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated at sodium salts), not more than 15 percent.
Volatile matter at 135 °C (275 °F), not more than 1.5 percent.
(a) Identity. (1) The color additive D&C Red No. 39 is o-[p(β,β′-dihydroxy-diethylamino)-phenylazo]-benzoic acid.
Volatile matter (at 100 °C.), not more than 2.0 percent.
N,N-(β,β′-Dihydroxy-diethyl) aniline, not more than 0.2 percent.
(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.
(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).
(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.
Volatile matter (at 135 °C.), not more than 2.0 percent.
(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).
(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)-1H-indene-1,3 (2H)-dione consisting principally of the sodium salts of 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-6-quinolinesulfonic acid and 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-8-quinolinesulfonic acid with lesser amounts of the disodium salts of the disulfonic acids of 2-(2-quinolinyl)-1H-indene-1,3(2H)-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-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 4 parts per million.
Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not less than 75 percent.
Sum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 15 percent.
2-(2,3-Dihydro-1,3-dioxo-1H-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)-1H-indene-1,3 (2H)-dione for calibration.
Volatile matter (at 135 °C), not more than 1 percent.