ASTM F2605-16
(Test Method)Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
SIGNIFICANCE AND USE
4.1 The composition and sequential structure of alginate, as well as the molar mass and molar mass distribution, determines the functionality of alginate in an application. For instance, the gelling properties of an alginate are highly dependent upon the composition and molar mass of the polymer.
4.2 Light scattering is one of very few methods available for the determination of absolute molar mass and structure, and it is applicable over the broadest range of molar masses of any method. Combining light scattering detection with size exclusion chromatography (SEC), which sorts molecules according to size, gives the ability to analyze polydisperse samples, as well as to obtain information on branching and molecular conformation. This means that both the number-average and mass-average values for molar mass and size may be obtained for most samples. Furthermore, one has the ability to calculate the distributions of the molar masses and sizes.
4.3 Multi-angle laser light scattering (MALS) is a technique where measurements are made simultaneously over a range of different angles and used to determine the scattering at 0°, which directly relates to molecular weight. MALS detection can be used to obtain information on molecular size, since this parameter is determined by the angular variation of the scattered light. This can be related to branching, aggregation, and molecular conformation. Molar mass can also be determined by detecting scattered light at a single low angle (LALS) and assuming that this is not significantly different from the scattering at 0°.
4.4 Size exclusion chromatography uses columns, which are typically packed with polymer particles containing a network of uniform pores into which solute and solvent molecules can diffuse. While in the pores, molecules are effectively trapped and removed from the flow of the mobile phase. The average residence time in the pores depends upon the size of the solute molecules. Molecules that are larger than the ...
SCOPE
1.1 This test method covers the determination of the molar mass (typically expressed as grams/mole) 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 F2064.
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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
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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.
Designation: F2605 − 16
Standard Test Method for
Determining the Molar Mass of Sodium Alginate by Size
Exclusion Chromatography with Multi-angle Light Scattering
1
Detection (SEC-MALS)
This standard is issued under the fixed designation F2605; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F2315 Guide for Immobilization or Encapsulation of Living
Cells or Tissue in Alginate Gels
1.1 This test method covers the determination of the molar
3
mass (typically expressed as grams/mole) of sodium alginate 2.2 United States Pharmacopeia/National Formulary:
intendedforuseinbiomedicalandpharmaceuticalapplications <621> Chromatography
as well as in tissue-engineered medical products (TEMPs) by 4
2.3 National Institute of Standards and Technology:
size exclusion chromatography with multi-angle laser light
NIST SP811 Special Publication: Guide for the Use of the
scattering detection (SEC-MALS). A guide for the character-
International System of Units
ization of alginate has been published as Guide F2064.
5
2.4 ISO Standards:
1.2 Alginate used in TEMPs should be well characterized,
ISO 31-8 Quantities and units- Part 8: Physical chemistry
including the molar mass and polydispersity (molar mass
and molecular physics
distribution) in order to ensure uniformity and correct func-
tionality in the final product. This test method will assist end
3. Terminology
users in choosing the correct alginate for their particular
3.1 Definitions:
application. Alginate may have utility as a scaffold or matrix
3.1.1 alginate, n—a polysaccharide substance extracted
material for TEMPs, in cell and tissue encapsulation
from brown algae, mainly occurring in the cell walls and
applications, and in drug delivery formulations.
intercellular spaces of brown seaweed and kelp. Its main
1.3 The values stated in SI units are to be regarded as
function is to contribute to the strength and flexibility of the
standard. No other units of measurement are included in this
seaweed plant. Sodium alginate, and in particular calcium
standard.
cross-linkedalginategelsareusedintissue-engineeredmedical
1.4 This standard does not purport to address all of the
products (TEMPs) as biomedical scaffolds and matrices, for
safety concerns, if any, associated with its use. It is the
immobilizing living cells (see Guide F2315), and in drug
responsibility of the user of this standard to establish appro-
delivery systems.
priate safety and health practices and determine the applica-
3.1.2 molar mass average, n—the given molar mass (Mw)
bility of regulatory limitations prior to use.
of an alginate will always represent an average of all of the
molecules in the population. The most common ways to
2. Referenced Documents
¯
expressthemolarmassareasthe number average(M )andthe
n
2
2.1 ASTM Standards: ¯
mass average (M ). The two averages are defined by the
w
F2064 Guide for Characterization and Testing of Alginates
following equations:
as Starting Materials Intended for Use in Biomedical and
2
N M w M N M
(i i i (i i i (i i i
Tissue Engineered Medical Product Applications
¯ ¯
M 5 and M 5 5 (1)
n w
N w N M
(i i (i i (i i i
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
3
F04.42 on Biomaterials and Biomolecules for TEMPs. Available from United States Pharmacopeia and National Formulary, U.S.
Current edition approved May 1, 2016. Published June 2016. Originally Pharmaceutical Convention, Inc. (USPC), Rockville, MD.
ϵ1
4
approved in 2008. Last previous edition approved in 2008 as F2605 – 08 . DOI: Available from National Institute of Standards and Technology (NIST), 100
10.1520/F2605-16. Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, http://physics.nist.gov/cuu/
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Units/bibliography.html.
5
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from International Organization for Standardization (ISO), ISO
Standards volume information, refer to the standard’s Document Summary page on Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
the ASTM website. Geneva, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2605 − 16
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: F2605 − 08 F2605 − 16
Standard Test Method for
Determining the Molar Mass of Sodium Alginate by Size
Exclusion Chromatography with Multi-angle Light Scattering
1
Detection (SEC-MALS)
This standard is issued under the fixed designation F2605; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Subsection 6.1.5 was editorially corrected in September 2008.
1. Scope
1.1 This test method covers the determination of the molar mass (typically expressed as grams/mole) of sodium alginate
intended for use in biomedical and pharmaceutical applications as well as in tissue engineered 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 F2064.
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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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
2
2.1 ASTM Standards:
F2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue
Engineered Medical Product Applications
F2315 Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
3
2.2 United States Pharmacopeia/National Formulary:
<621> Chromatography
4
2.3 National Institute of Standards and Technology:
NIST SP811 Special Publication: Guide for the Use of the International System of Units
5
2.4 ISO Standards:
ISO 31-8 Quantities and units- Part 8: Physical chemistry and molecular physics
3. Terminology
3.1 Definitions:
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.42 on Biomaterials and Biomolecules for TEMPs.
ϵ1
Current edition approved Feb. 1, 2008May 1, 2016. Published May 2008June 2016. Originally approved in 2008. Last previous edition approved in 2008 as F2605 – 08 .
DOI: 10.1520/F2605-08E01.10.1520/F2605-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from United States Pharmacopeia and National Formulary, U.S. Pharmaceutical Convention, Inc. (USPC), Rockville, MD.
4
Available from National Institute of Standards and Technology (NIST), 100 Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, http://physics.nist.gov/cuu/Units/
bibliography.html.
5
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2605 − 16
3.1.1 alginate, n—a polysaccharide substance extracted from brown algae, mainly occurring in the cell walls and intercellular
spaces of brown seaweed and kelp. Its main function is to contribute to the strength and flexibility of the seaweed plant. Sodium
alginate, and in particular calcium cross-linked alginate gels are used in tissue engineered tissue-engineered medical products
(TEMPs) as biomedical scaffolds and matrices, for immobilizing living cells (see Guide F2315)), and in drug delivery systems.
3.1.2 molar mass average, n—the given molar mass (Mw) of an alginate will always represent an avera
...
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