[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: 21CFR73.1025]
[Page 359-360]
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. 73.1025 Ferric ammonium citrate.
(a) Identity. The color additive ferric ammonium citrate consists of
complex chelates prepared by the interaction of ferric hydroxide with
citric acid in the presence of ammonia. The complex chelates occur in
brown and green forms, are deliquescent in air, and are reducible by
light.
(b) Specifications. Ferric ammonium citrate 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:
Iron (as Fe), not less than 14.5 percent and not more than 18.5 percent.
Lead (as Pb), not more than 20 p/m.
Arsenic (as As), not more than 3 p/m.
(c) Uses and restrictions. Ferric ammonium citrate may be safely
used in combination with pyrogallol (as listed in Sec. 73.1375), for
coloring plain and chromic catgut sutures for use in general and
ophthalmic surgery subject to the following conditions:
[[Page 360]]
(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
tissue.
(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 labeling 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 requirements of section
721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]
Back to Top
© 2007 Betterchem Corp.
|
