[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

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

[CITE: 40CFR792.113]



[Page 42]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 792_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

            Subpart F_Test, Control, and Reference Substances

 

Sec.  792.113  Mixtures of substances with carriers.



    (a) For each test, control, or reference substance 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, control, or reference 

substance in the mixture.

    (2) When relevant to the conduct of the experiment, to determine the 

solubility of each test, control, or reference substance in the mixture 

by the testing facility or the sponsor before the experimental start 

date.

    (3) To determine the stability of the test, control or reference 

substance in the mixture before the experimental start date or 

concomitantly according to written standard operating procedures, which 

provide for periodic analysis of each batch.

    (b) Where any of the components of the test, control, or reference 

substance 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.

    (c) If a vehicle is used to facilitate the mixing of a test 

substance with a carrier, assurance shall be provided that the vehicle 

does not interfere with the integrity of the test.