[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.113]

[Page 315]
 
                        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]

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