You are using an unsupported browser. This web site is designed for the current versions of Microsoft Edge, Google Chrome, Mozilla Firefox, or Safari.
The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. We recommend you directly contact the agency associated with the content in question.
If you have comments or suggestions on how to improve the www.ecfr.gov website or have questions about using www.ecfr.gov, please choose the 'Website Feedback' button below.
If you would like to comment on the current content, please use the 'Content Feedback' button below for instructions on contacting the issuing agency
Enhanced content is provided to the user to provide additional context.
This content is from the eCFR and is authoritative but unofficial.
Navigate by entering citations or phrases (eg: 1 CFR 1.1 49 CFR 172.101 Organization and Purpose 1/1.1 Regulation Y FAR).
Choosing an item from citations and headings will bring you directly to the content. Choosing an item from full text search results will bring you to those results. Pressing enter in the search box will also bring you to search results.
Background and more details are available in the Search & Navigation guide.
The in-page Table of Contents is available only when multiple sections are being viewed.
Use the navigation links in the gray bar above to view the table of contents that this content belongs to.
This content is from the eCFR and may include recent changes applied to the CFR. The official, published CFR, is updated annually and available below under "Published Edition". You can learn more about the process here.
Subscribe to: 21 CFR 73.1010
No changes found for this content after 1/03/2017.
View the most recent official publication:
These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.
Information and documentation can be found in our developer resources.
The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.
Learn more about the eCFR, its status, and the editorial process.
Nomenclature changes to part 73 appear at 66 FR 66742, Dec. 27, 2001.
(a) Identity.
(1) The color additive alumina (dried aluminum hydroxide) is a white, odorless, tasteless, amorphous powder consisting essentially of aluminum hydroxide (Al2 O3· XH2 O).
(2) Color additive mixtures for drug use made with alumina (dried aluminum hydroxide) may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Alumina (dried aluminum hydroxide) shall conform to the following specifications:
Acidity or alkalinity: Agitate 1 gram of the color additive with 25 milliliters of water and filter. The filtrate shall be neutral to litmus paper.
Matter insoluble in dilute hydrochloric acid, not more than 0.5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.
Aluminum oxide (Al2 O3), not less than 50 percent.
(c) Uses and restrictions. Alumina (dried aluminum hydroxide) may be safely used in amounts consistent with good manufacturing practice to color drugs generally.
(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.