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: 21CFR58.113]
[Page 316]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES--Table of Contents
Subpart F--Test and Control Articles
Sec. 58.113 Mixtures of articles with carriers.
(a) For each test or control article that is mixed with a carrier,
tests by appropriate analytical methods shall be conducted:
(1) To determine the uniformity of the mixture and to determine,
periodically, the concentration of the test or control article in the
mixture.
(2) To determine the stability of the test and control articles in
the mixture as required by the conditions of the study either:
(i) Before study initiation, or
(ii) Concomitantly according to written standard operating
procedures which provide for periodic analysis of the test and control
articles in the mixture.
(b) [Reserved]
(c) Where any of the components of the test or control article
carrier mixture has an expiration date, that date shall be clearly shown
on the container. If more than one component has an expiration date, the
earliest date shall be shown.
[43 FR 60013, Dec. 22, 1978, as amended at 45 FR 24865, Apr. 11, 1980;
52 FR 33781, Sept. 4, 1987]
[[Page 317]]