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ASTM F2605-08e1

(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
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.
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 obtaining 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.
Multi-angle laser light scattering (MALS) is a technique where measurements are made simultaneously over a range of different angles. MALS detection can be used to obtain information on molecular size, since this parameter is determined by the angular variation of the scattered light. Molar mass may in principle be determined by detecting scattered light at a single low angle (LALLS). However, advantages with MALS as compared to LALLS are: (1) less noise at larger angles, (2) the precision of measurements are greatly improved by detecting at several angles, and (3) the ability to detect angular variation allows determination of size, branching, aggregation, and molecular conformation.
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...
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 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.

General Information

Status
Historical
Publication Date
31-Jan-2008
ICS
11.120.10 - Medicaments
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Replaces
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)
Effective Date
01-Feb-2008
Replaced By
ASTM F2605-16 - Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
Effective Date
01-May-2016
Referred By
ASTM F2064-17 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Effective Date
01-Feb-2008

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ASTM F2605-08e1 - Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)ASTM F2605-08e1 - Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
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ASTM F2605-08e1 - Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´1
Designation: F2605 − 08
StandardTest 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 Tissue Engineered Medical Product Applications
F2315 Guide for Immobilization or Encapsulation of Living
1.1 This test method covers the determination of the molar
Cells or Tissue in Alginate Gels
mass of sodium alginate intended for use in biomedical and
3
2.2 United States Pharmacopeia/National Formulary:
pharmaceutical applications as well as in tissue engineered
<621> Chromatography
medical products (TEMPs) by size exclusion chromatography
4
2.3 National Institute of Standards and Technology:
with multi-angle laser light scattering detection (SEC-MALS).
NIST SP811 Special Publication: Guide for the Use of the
Aguide for the characterization of alginate has been published
International System of Units
as Guide F2064.
1.2 Alginate used in TEMPs should be well characterized, 3. Terminology
including the molar mass and polydispersity (molar mass
3.1 Definitions:
distribution) in order to ensure uniformity and correct func-
3.1.1 alginate, n—a polysaccharide substance extracted
tionality in the final product. This test method will assist end
from brown algae, mainly occurring in the cell walls and
users in choosing the correct alginate for their particular
intercellular spaces of brown seaweed and kelp. Its main
application. Alginate may have utility as a scaffold or matrix
function is to contribute to the strength and flexibility of the
material for TEMPs, in cell and tissue encapsulation
seaweed plant. Sodium alginate, and in particular calcium
applications, and in drug delivery formulations.
cross-linkedalginategelsareusedintissueengineeredmedical
1.3 The values stated in SI units are to be regarded as products (TEMPs) as biomedical scaffolds and matrices, for
standard. No other units of measurement are included in this
immobilizing living cells (see Guide F2315) and in drug
standard.
delivery systems.
1.4 This standard does not purport to address all of the
3.1.2 molar mass average, n—the given molar mass (Mw)
safety concerns, if any, associated with its use. It is the
of an alginate will always represent an average of all of the
responsibility of the user of this standard to establish appro-
molecules in the population. The most common ways to
¯
priate safety and health practices and determine the applica-
expressthemolarmassareasthe number average(M )andthe
n
¯
bility of regulatory limitations prior to use.
mass average (M ). The two averages are defined by the
w
following equations:
2. Referenced Documents
2
N M w M N M
(i i i (i i i (i i i
2
¯ ¯
2.1 ASTM Standards: M 5 and M 5 5 (1)
n w
N w N M
(i i (i i (i i i
F2064 Guide for Characterization and Testing of Alginates
as Starting Materials Intended for Use in Biomedical and
where:
N = number of molecules having a specific molar mass M,
i i
and
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
w = mass of molecules having a specific molar mass M.
i i
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.42 on Biomaterials and Biomolecules for TEMPs.
Current edition approved Feb. 1, 2008. Published May 2008. DOI: 10.1520/
3
F2605-08E01. Available from United States Pharmacopeia and National Formulary, U.S.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Pharmaceutical Convention, Inc. (USPC), Rockville, MD.
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from National Institute of Standards and Technology (NIST), 100
Standards volume information, refer to the standard’s Document Summary page on Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, http://physics.nist.gov/cuu/
the ASTM website. Units/bibliography.html.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
F2605 − 08
1

---------------------- Page: 2 ----------------------
´1
F2605 − 08
5
3.1.2.1 Discussion—In a polydisperse molecular population in the molar mass determination by light scattering (1, 2).
¯ ¯ ¯ ¯
the relation M > M is always valid.The coefficient M /M is However, in the present method, the size exclusion chroma-
w n w n
referred to as the polydispersity i
...

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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.  
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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.  
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4.1 Guidelines for unintended human exposure to active pharmaceutical ingredients (APIs) are required by various global regulations as part of international quality requirements, needed as good product stewardship, and are considered the industry standard.  
4.2 Application of the approach described within this guide applies a scientifically justified, data-driven, approach to deriving safe limits for unintended exposures to individual substances. These limits can then be further used to calculate cleaning limits used in quality risk assessment for the manufacture of pharmaceuticals. The HBEL approach considers substance-specific properties (type of effect, potency, pharmacology, safety profile, and so forth). Specific approaches are applicable to different categories of substances and in specific stages in drug development.  
4.3 The basis for the HBEL derivation is all available substance-specific data. Interpretation of these data considers the quantity and robustness of the database and the reliability and relevance of the data. Typically, adjustment factors (AFs) are used to address variability and uncertainty in different parameters to determine a safe human exposure limit, although alternative, purposefully conservative, approaches [for example, threshold of toxicological concern (TTC), read-across] may be used as appropriate.  
4.4 This guide supports, and is consistent with, elements of the European Commission (EU) Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (27, 28) and guidance from the International Society of Pharmaceutical Engineers (ISPE) (29) in which it is mentioned that relevant residue limits should be based on a toxicological evaluation.  
4.5 Key Concepts—This guide applies the following steps: (1) hazard characterization, (2) identification of the critical effect(s) including dose-response assessment, (3) determination of one or several points of departure (PoD)s, (4) application of PoD-spe...
SCOPE
1.1 This guide describes the scientific procedures underlying the integrative interpretation of all data concerning an active pharmaceutical ingredient (API) taking into account study adequacy, relevance, reliability, validity, and compound-specific characteristics (for example, potency, toxicological profile, and pharmacokinetics) leading to a numerical value for the API, which is used further in the quality risk management (ICH Q9) of cross contamination during the manufacture of different products in the same manufacturing facilities.  
1.2 This guide describes general guidance for calculating and documenting a health-based exposure limit (HBEL). It should serve the involved qualified experts as a reference for HBEL derivations and should harmonize the different approaches and nomenclature to the greatest extent possible.  
1.3 This guide should be used for calculating and documenting an HBEL, when required or necessary, for APIs (including biologics), intermediates, cleaning agents, excipients, and other chemicals (that is, reagents, manufacturing residues, and so forth) used for cleaning validation and verification (Guides F3127 and E3106). In scope is the cleaning and cross contamination of surfaces of manufacturing equipment and medical devices but does not include leachables/extractables (21 CFR 211.67, 21 CFR 610.11, 21 CFR 820.70, and 21 CFR 111.27).  
1.4 The principles in this guide may also be used as a basis for setting occupational exposure limits.  
1.5 The principles in this guide may be applied during the development and commercial manufacturing of small or large molecular weight medicines as well as isolated pharmaceutical intermediates.  
1.6 Subsequent-product HBEL values may be set for specific routes of exposure (for example, oral, inhalation, and parenteral) when necessary (for example, because of differences in bioavailability) and for specific patient populations (for example, children) if ...

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ASTM
ASTM F2602-18(Test Method)
Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)

SIGNIFICANCE AND USE
4.1 The degree of deacetylation of chitosan, as well at the molar mass and molar mass distribution, determines the functionality of chitosan in an application. For instance, functional and biological effects are highly dependent upon the composition and molar mass of the polymer.  
4.2 This test method describes procedures for measurement of molar mass of chitosan chlorides and glutamates, and chitosan base, although it in principle applies to any chitosan salt. The measured molar mass is that for chitosan acetate, since the mobile phase contains acetate as counter ion. This value can further be converted into the corresponding molar mass for the chitosan as a base, or the parent salt form (chloride or glutamate).  
4.3 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 obtaining 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.  
4.4 Multi-angle laser light scattering (MALS) is a technique where measurements of scattered light are made simultaneously over a range of different angles. MALS detection can be used to obtain information on molecular size, since this parameter is determined by the angular variation of the scattered light. Molar mass may in principle be determined by detecting scattered light at a single low angle (LALLS). However, advantages with MALS as compared to LALLS are: (1) less noise at larger angles, (2) precision of measurements is improved by detecting at several angles, and (3) the ability to detect angular v...
SCOPE
1.1 This test method covers the determination of the molar mass of chitosan and chitosan salts 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 chitosan salts has been published as Guide F2103.  
1.2 Chitosan and chitosan salts 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 chitosan for their particular application. Chitosan 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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.

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  • Standard
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