[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2005]

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.