[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.105]

[Page 310]
 
                        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 
 
                   Subpart F_Test and Control Articles
 
Sec.  58.105  Test and control article characterization.


    (a) The identity, strength, purity, and composition or other 
characteristics which will appropriately define the test or control 
article shall be determined for each batch and shall be documented. 
Methods of synthesis, fabrication, or derivation of the test and control 
articles shall be documented by the sponsor or the testing facility. In 
those cases where marketed products are used as control articles, such 
products will be characterized by their labeling.
    (b) The stability of each test or control article shall be 
determined by the testing facility or by the sponsor either: (1) Before 
study initiation, or (2) concomitantly according to written standard 
operating procedures, which provide for periodic analysis of each batch.
    (c) Each storage container for a test or control article shall be 
labeled by name, chemical abstract number or code number, batch number, 
expiration date, if any, and, where appropriate, storage conditions 
necessary to maintain the identity, strength, purity, and composition of 
the test or control article. Storage containers shall be assigned to a 
particular test article for the duration of the study.
    (d) For studies of more than 4 weeks' duration, reserve samples from 
each batch of test and control articles shall be retained for the period 
of time provided by Sec.  58.195.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]

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