This electronic document was downloaded from the GPO web site, September 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[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: 21CFR74.1330]
[Page 408]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
Subpart B--Drugs
Sec. 74.1330 D&C Red No. 30.
(a) Identity. (1) The color additive D&C Red No. 30 is principally
6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-
methyl-benzo[b]thiophen-3(2H)-one (CAS Reg. No. 2379-74-0).
(2) Color additive mixtures for drug use made with D&C Red No. 30
may contain only those diluents that are suitable and that are listed in
part 73 of this chapter as safe for use in color additive mixtures for
coloring drugs.
(b) Specifications. D&C Red No. 30 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 current good
manufacturing practice:
Volatile matter (at 135 deg.C), not more than 5 percent.
Chlorides and sulfates (calculated as sodium salts), not more than 3
percent.
Matter soluble in acetone, not more than 5 percent.
Total color, not less than 90 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. D&C Red No. 30 may be safely used for
coloring drugs generally in amounts consistent with current good
manufacturing practice.
(d) Labeling. The label 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) Certification. All batches of D&C Red No. 30 shall be certified
in accordance with regulations in part 80 of this chapter.
[47 FR 22510, May 25, 1982]