[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1400]
[Page 366-367]
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
Subpart B Drugs
Sec. 73.1400 Pyrophyllite.
(a) Identity. (1) The color additive pyrophyllite is a naturally
occurring
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mineral substance consisting predominantly of a hydrous aluminum
silicate,
Al2O3[middot]4SiO2[middot]H2
O, intimately mixed with lesser amounts of finely divided silica,
SiO2. Small amounts, usually less than 3 percent, of other
silicates, such as potassium aluminum silicate, may be present.
Pyrophyllite may be identified and semiquantitatively determined by its
characteristic X-ray powder diffraction pattern and by its optical
properties.
(2) Color additive mixtures made with pyrophyllite are limited to
those listed in this subpart as safe and suitable in color additive
mixtures for coloring externally applied drugs.
(b) Specifications. Pyrophyllite shall conform to the following
specifications:
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Lead and arsenic shall be determined in the solution obtained by boiling
10 grams of the pyrophyllite for 15 minutes in 50 milliliters of 0.5N
hydrochloric acid.
(c) Uses and restrictions. Pyrophyllite may be safely used in
amounts consistent with good manufacturing practice to color drugs that
are to be externally applied.
(d) Labeling requirements. The labeling of the color additive and
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.
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