part_subject: "GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES"
subpart_code: "F"
subpart_subject: "Test and Control Articles"
section_number: "58.113"
section_subject: "Mixtures of articles with carriers."
cfr_reference: "21 CFR 58.113"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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:
(ii)Concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture.
(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.