[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: 21CFR73.1410]
[Page 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. 73.1410 Logwood extract.
(a) Identity. The color additive logwood extract is a reddish brown-
to-black solid material extracted from the heartwood of the leguminous
tree Haematoxylon campechianum. The active colorant substance is
principally hematein. The latent coloring material is the unoxidized or
leuco form of hematein called hematoxylin. The leuco form is oxidized by
air.
(b) Specifications. Logwood extract shall conform to the following
specifications and shall be free from impurities other than those named
to the extent that such imnurities may be avoided by good manufacturing
practice:
Volatile matter (at 110 [deg]C), not more than 15 percent.
Sulfated ash, not more than 20 percent.
Hematein, not less than 5 percent and not more than 20 percent.
Lead (as Pb), not more than 70 parts per million.
Arsenic (as As), not more than 4 parts per million.
Mercury (as Hg), not more than 3 parts per million.
(c) Use and restrictions. Logwood extract may be safely used to
color nylon 66 (the copolymer of hexamethylenediamine and adipic acid),
nylon 6 (the polymer of e-caprolactam), or silk non-absorable sutures
for use in general and ophthalmic surgery subject to the following
restrictions:
(1) The quantity of color additive does not exceed 1.0 percent by
weight of the suture.
(2) When the sutures are used for the purposes specified in their
labeling, there is no migration of the color additive to the surrounding
tissue.
(3) 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 52393, Sept. 30, 1977; 43 FR 1490, Jan. 10, 1978]
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