[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: 21CFR73.1400]
 
 [Page 370]
 
                         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. 73.1400  Pyrophyllite.
 
     (a) Identity. (1) The color additive pyrophyllite is a naturally
 occurring mineral substance consisting predominantly of a hydrous
 aluminum silicate,
 Al<INF>2</INF>O<INF>3</INF><t-bullet>
 4SiO<INF>2</INF><t-bullet>H<INF>2</INF>0,
 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.