[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR160.105]

[Page 150-151]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 160--GOOD LABORATORY PRACTICE STANDARDS--Table of Contents
 
           Subpart F--Test, Control, and Reference Substances
 
Sec. 160.105  Test, control, and reference substance characterization.


    (a) The identity, strength, purity, and composition, or other 
characteristics which will appropriately define the test, control, or 
reference substance shal1 be determined for each batch and shall be 
documented before its use in a study. Methods of synthesis, fabrication, 
or derivation of the test, control, or reference substance shall be 
documented by the sponsor or the testing facility, and the location of 
such documentation shall be specified.
    (b) When relevant to the conduct of the study the solubility of each 
test, control, or reference substance shall be determined by the testing 
facility or the sponsor before the experimental start date. The 
stability of the test, control, or reference substance shall be 
determined before the experimental start date or concomitantly according 
to written standard operating procedures, which provide for periodic 
analysis of each batch.
    (c) Each storage container for a test, control, or reference 
substance shall be labeled by name, chemical abstracts service number 
(CAS) or code number, batch number, expiration date, if any, and, where 
appropriate, storage conditions necessary to maintain the identity, 
strength, purity, and composition

[[Page 151]]

of the test, control, or reference substance. Storage containers shall 
be assigned to a particular test substance for the duration of the 
study.
    (d) For studies of more than 4 weeks experimental duration, reserve 
samples from each batch of test, control, and reference substances shall 
be retained for the period of time provided by Sec. 160.195.
    (e) The stability of test, control, and reference substances under 
storage conditions at the test site shall be known for all studies.