ASTM-E2525 2022

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E2525-22 Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies

Published By	Publication Date	Number of Pages
ASTM	2022

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Categories: 07.100.10 - Medical microbiology, ASTM

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Description

ASTM E2525-22

Active Standard: Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies

ASTM E2525

Scope

1.1 This test method provides a protocol for quantitative analysis of the effect of nanoparticulate materials in physiologic solution (isotonic, pH 7.2 ± 0.2) on granulocyte-macrophage colony-forming units (CFU-GM).

1.2 CFU-GM reflects the number of viable bone marrow cells which differentiate into granulocytes and macrophages. A decrease in CFU-GM count is indicative of a test substance’s toxicity to bone marrow and is commonly used for the identification of drug products with myelosuppressive properties, a form of immunosuppression.

1.3 This test method employs murine bone marrow hematopoietic stem cells which proliferate and differentiate to form discrete cell clusters or colonies which are counted.

1.4 This test method is part of the in vitro preclinical characterization cascade for nanoparticulate materials for systemic administration in medical applications.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

bone marrow; CFU-GM; clonogenic assay; granulocyte; macrophage; myelosuppression; nanoparticles; preclinical development; stem cells;

ICS Code

ICS Number Code 07.100.10 (Medical microbiology)

DOI: 10.1520/E2525-22

Additional information

Standard Title	E2525-22 Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies
Published Code	ASTM
Publication Date	2022
ICS Codes	07.100.10 - Medical microbiology