[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: 21CFR74.1336]
 
[Page 410]
 
                        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. 74.1336  D&C Red No. 36.
 
    (a) Identity. (1) The color additive D&C Red No. 36 is 1-[(2-chloro-
4-nitrophenyl)azo]-2-naphthalenol (CAS Reg. No. 2814-77-9). The color
additive is manufactured by diazotization of 2-chloro-4-nitrobenzenamine
in acid medium and coupling with 2-naphthalenol in acid medium.
    (2) Color additive mixtures for drug use made with D&C Red No. 36
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. 36 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 (275 deg.F), not more than 1.5 percent.
Matter insoluble in toluene, not more than 1.5 percent.
2-Chloro-4-nitrobenzenamine, not more than 0.3 percent.
2-Naphthalenol, not more than 1 percent.
2,4-Dinitrobenzenamine, not more than 0.02 percent.
1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent.
4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5
percent.
1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent.
1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthalenol, not more than 0.3
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.
Total color, not less than 95 percent.
 
    (c) Uses and restrictions. The color additive D&C Red No. 36 may be
safely used for coloring ingested drugs, other than mouthwashes and
dentifrices, in amounts not to exceed 1.7 milligrams per daily dose of
the drug for drugs that are taken continuously only for less than 1
year. For drugs taken continuously for longer than 1 year, the color
additive shall not be used in amounts to exceed 1.0 milligram per daily
dose of the drug. D&C Red No. 36 may be safely used for coloring
externally applied drugs in amounts consistent with current good
manufacturing practice.
    (d) Labeling requirements. 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. 36 shall be certified
in accordance with regulations in part 80 of this chapter.
 
[53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept. 12, 1988, as amended at
53 FR 52130, Dec. 27, 1988]