[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: 21CFR73.1375]
[Page 366]
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. 73.1375 Pyrogallol.
(a) Identity. The color additive pyrogallol is 1,2,3-
trihydroxybenzene.
(b) Specifications. Pyrogallol shall conform to the following
specifications and shall be free from impurities other than those named
to the extent that such impurities may be avoided by good manufacturing
practice:
Melting point, between 130[deg] and 133 [deg]C.
Residue on ignition, not more than 0.1 percent.
Lead (as Pb), not more than 20 p/m (parts per million).
Arsenic (as As), not more than 3 p/m.
(c) Uses and restrictions. Pyrogallol may be safely used in
combination with ferric ammonium citrate (as listed in Sec. 73.1025),
for coloring plain and chromic catgut sutures for use in general and
ophthalmic surgery, subject to the following restrictions:
(1) The dyed suture shall conform in all respects to the
requirements of the United States Pharmacopeia XX (1980).
(2) The level of the ferric ammonium citrate-pyrogallol complex
shall not exceed 3 percent of the total weight of the suture material.
(3) When the sutures are used for the purposes specified in their
labeling, there is no migration of the color additive to the surrounding
tissues.
(4) If the suture is a new drug, an approved new drug application,
pursuant to section 505 of the act, is in effect for it.
(d) Labeling. The label of the color additive 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.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]
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