ASTM F2605-08
Historical Standard: ASTM F2605-08 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
SUPERSEDED (see Active link, below)
ASTM F2605
1. Scope
1.1 This test method covers the determination of the molar mass of sodium alginate intended for use in biomedical and pharmaceutical applications as well as in tissue engineered medical products (TEMPs) by size exclusion chromatography with multi-angle laser light scattering detection (SEC-MALS). A guide for the characterization of alginate has been published as Guide F 2064 .
1.2 Alginate used in TEMPs should be well characterized, including the molar mass and polydispersity (molar mass distribution) in order to ensure uniformity and correct functionality in the final product. This test method will assist end users in choosing the correct alginate for their particular application. Alginate may have utility as a scaffold or matrix material for TEMPs, in cell and tissue encapsulation applications, and in drug delivery formulations.
1.3 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
F2315 Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
United States Pharmacopeia/National Formulary
<621> ChromatographyNational Institute of Standards and Technology
NISTSP811 Special Publication: Guide for the Use of the International System of UnitsKeywords
Alginates; Size exclusion chromatography with multi-angle light scattering detection (SEC-MALS); Tissue engineered medical products (TEMPs);
ICS Code
ICS Number Code 11.120.10 (Medicaments)
DOI: 10.1520/F2605-08
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