[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
Sec. 73.1010 Alumina (dried aluminum hydroxide).
(a) Identity. (1) The color additive alumina (dried aluminum
hydroxide) is a white, odorless, tasteless, amorphous powder consisting
essentially of aluminum hydroxide (Al2 O3[middot]
(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
(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 Sec. 70.25 of this
(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.
Additives that reference this regulation: