CFR
- Title 1 - General Provisions
- Title 2 - Grants and Agreements
- Title 3 - The President
- Title 4 - Accounts
- Title 5 - Administrative Personnel
- Title 6 - Domestic Security
- Title 7 - Agriculture
- Title 8 - Aliens and Nationality
- Title 9 - Animals and Animal Products
- Title 10 - Energy
- Title 11 - Federal Elections
- Title 12 - Banks and Banking
- Title 13 - Business Credit and Assistance
- Title 14 - Aeronautics and Space
- Title 15 - Commerce and Foreign Trade
- Title 16 - Commercial Practices
- Title 17 - Commodity and Securities Exchanges
- Title 18 - Conservation of Power and Water Resources
- Title 19 - Customs Duties
- Title 20 - Employees' Benefits
- Title 21 - Food and Drugs
- Title 22 - Foreign Relations
- Title 23 - Highways
- Title 24 - Housing and Urban Development
- Title 25 - Indians
- Title 26 - Internal Revenue
- Title 27 - Alcohol, Tobacco Products and Firearms
- Title 28 - Judicial Administration
- Title 29 - Labor
- Title 30 - Mineral Resources
- Title 31 - Money and Finance: Treasury
- Title 32 - National Defense
- Title 33 - Navigation and Navigable Waters
- Title 34 - Education
- Title 35 - Panama Canal
- Title 36 - Parks, Forests, and Public Property
- Title 37 - Patents, Trademarks, and Copyrights
- Title 38 - Pensions, Bonuses, and Veterans' Relief
- Title 39 - Postal Service
- Title 40 - Protection of Environment
- Title 41 - Public Contracts and Property Management
- Title 42 - Public Health
- Title 43 - Public Lands: Interior
- Title 44 - Emergency Management and Assistance
- Title 45 - Public Welfare
- Title 46 - Shipping
- Title 47 - Telecommunication
- Title 48 - Federal Acquisition Regulations System
- Title 49 - Transportation
- Title 50 - Wildlife and Fisheries
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.
Tips