[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR58.113]



[Page 309]

 

                        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]