This electronic document was downloaded from the GPO web site, August 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

 
 [Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.1010]
 
 [Page 362]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                             Subpart B--Drugs
 
 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 (Al<INF>2</INF>
 O<INF>3</INF><t-bullet> XH<INF>2</INF> 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 (Al<INF>2</INF> O<INF>3</INF>), 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
 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.


Color Additive Regulations
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