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73.1010 Alumina (dried aluminum hydroxide).

Home > Regulations > Listing of color additives exempt from certification > 73.1010 Alumina (dried aluminum hydroxide).






[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR73.1010]



[Page 356-357]

 

                        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 (Al2 O3[middot] 

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



[[Page 357]]



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 

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.










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1010


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