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ASTM F2259-03(2008)

(Test Method)

Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy

SIGNIFICANCE AND USE
The composition and sequential structure of alginate determines the functionality of alginate in an application. For instance, the gelling properties of an alginate are highly dependent upon the monomer composition and sequential structure of the polymer. Gel strength will depend upon the guluronic acid content (FG) and also the average number of consecutive guluronate moieties in G-block structures (NG>1).
Chemical composition and sequential structure of alginate can be determined by 1H- and 13C-nuclear magnetic resonance spectroscopy (NMR). A general description of NMR can be found in 761> of the USP24-NF19. The NMR methodology and assignments are based on data published by Grasdalen et al. (1979, 1981, 1983). , , The NMR technique has made it possible to determine the monad frequencies FM (fraction of mannuronate units) and FG (fraction of guluronate units), the four nearest neighboring (diad) frequencies FGG, FMG, FGM, FMM, and the eight next nearest neighboring (triad) frequencies FGGG, FGGM, FMGG, FMGM, FMMM, FMMG, FGMM, FGMG. Knowledge of these frequencies enables number averages of block lengths to be calculated. NG is the number average length of G-blocks, and NG>1 is the number average length of G-blocks from which singlets (-MGM-) have been excluded. Similarly, NM is the number average length of M-blocks, and NM>1 is the number average length of M-blocks from which singlets (-GMG-) have been excluded.  13C NMR must be used to determine the M-centered triads and NM>1. This test method describes only the 1H NMR analysis of alginate. Alginate can be well characterized by determining FG and NG>1.
In order to obtain well-resolved NMR spectra, it is necessary to reduce the viscosity and increase the mobility of the molecules by depolymerization of alginate to a degree of polymerization of about 20 to 50. Acid hydrolysis is used to depolymerize the alginate samples. Freeze-drying, followed by dissolution in 99 % D2O, and another freeze-drying before dissolut...
SCOPE
1.1 This test method covers the determination of the composition and monomer sequence of alginate intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR). A guide for the characterization of alginate has been published as Guide F 2064.
1.2 Alginate, a linear polymer composed of β-D-mannuronate (M) and its C-5 epimer α-L-guluronate (G) linked by β-(1—>4) glycosidic bonds, is characterized by calculating parameters such as mannuronate/guluronate (M/G) ratio, guluronic acid content (G-content), and average length of blocks of consecutive G monomers (that is, NG>1). Knowledge of these parameters is important for an understanding of the functionality of alginate in TEMP formulations and applications. 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
30-Apr-2008
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Replaced By
ASTM F2259-10 - Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy
Effective Date
01-Jun-2010

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ASTM F2259-03(2008) - Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) SpectroscopyASTM F2259-03(2008) - Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy
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ASTM F2259-03(2008) - Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy
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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.
Designation:F2259–03 (Reapproved 2008)
Standard Test Method for
Determining the Chemical Composition and Sequence in
1
Alginate by Proton Nuclear Magnetic Resonance ( H NMR)
1
Spectroscopy
This standard is issued under the fixed designation F2259; 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 E386 Practice for Data Presentation Relating to High-
Resolution Nuclear Magnetic Resonance (NMR) Spectros-
1.1 This test method covers the determination of the com-
copy
position and monomer sequence of alginate intended for use in
F2064 Guide for Characterization and Testing of Alginates
biomedical and pharmaceutical applications as well as in
as Starting Materials Intended for Use in Biomedical and
Tissue Engineered Medical Products (TEMPs) by high-
1
Tissue-Engineered Medical Products Application
resolution proton NMR ( H NMR). A guide for the character-
2.2 United States Pharmacopeia Document:
ization of alginate has been published as Guide F2064.
3
USP 24-NF19 <761> Nuclear Magnetic Resonance
1.2 Alginate, a linear polymer composed of b-D-
mannuronate (M) and its C-5 epimer a-L-guluronate (G)
3. Terminology
linked by b-(1—>4) glycosidic bonds, is characterized by
3.1 Definitions:
calculating parameters such as mannuronate/guluronate (M/G)
3.1.1 alginate, n—a polysaccharide substance extracted
ratio,guluronicacidcontent(G-content),andaveragelengthof
from brown algae, mainly occurring in the cell walls and
blocks of consecutive G monomers (that is, N ). Knowledge
G>1
intercellular spaces of brown seaweed and kelp. Its main
of these parameters is important for an understanding of the
function is to contribute to the strength and flexibility of the
functionality of alginate in TEMP formulations and applica-
seaweed plant. Sodium alginate, and in particular calcium
tions. This test method will assist end users in choosing the
cross-linked alginate gels are used in Tissue Engineered
correct alginate for their particular application. Alginate may
Medical Products (TEMPs) as biomedical matrices, controlled
have utility as a scaffold or matrix material for TEMPs, in cell
drug delivery systems, and for immobilizing living cells.
and tissue encapsulation applications, and in drug delivery
3.1.2 degradation, n—change in the chemical structure,
formulations.
physical properties, or appearance of a material. Degradation
1.3 The values stated in SI units are to be regarded as
ofpolysaccharidesoccursviacleavageoftheglycosidicbonds.
standard. No other units of measurement are included in this
It is important to note that degradation is not synonymous with
standard.
decomposition. Degradation is often used as a synonym for
1.4 This standard does not purport to address all of the
depolymerization when referring to polymers.
safety concerns, if any, associated with its use. It is the
3.1.3 depolymerization, n—reduction in the length of a
responsibility of the user of this standard to establish appro-
polymer chain to form shorter polymeric units.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Significance and Use
2. Referenced Documents 4.1 The composition and sequential structure of alginate
2 determines the functionality of alginate in an application. For
2.1 ASTM Standards:
instance, the gelling properties of an alginate are highly
dependent upon the monomer composition and sequential
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
structure of the polymer. Gel strength will depend upon the
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
guluronic acid content (F ) and also the average number of
G
F04.42 on Biomaterials and Biomolecules for TEMPs.
consecutive guluronate moieties in G-block structures (N ).
Current edition approved May 1, 2008. Published June 2008. Originally G>1
approved in 2003. Last previous edition approved in 2003 as F2259 – 03. DOI:
10.1520/F2259-03R08.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2259–03 (2008)
NOTE 1—For a sample in 100 % D O, the pH reading on a pH meter is
4.2 Ch
...

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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

SIGNIFICANCE AND USE
4.1 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen.  
4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.  
4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.  
4.4 The following documents or other appropriate guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs:    
FDA CFR:  
21 CFR 3: Product Jurisdiction:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=3    
21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=58    
FDA/CDRH CFR and Guidances:  
21 CFR Part 803: Medical Device ...
SCOPE
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.  
1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this...

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ASTM
ASTM F619-20(Practice)
Standard Practice for Extraction of Materials Used in Medical Devices

SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices.  
5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics or other materials to extraction vehicles.  
5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 7).  
5.4 Caution should be exercised in the understanding and intent of this practice as follows:  
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748.  
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, absorptive (for example, sponge-like materials that are capable of absorbing liquid), or resorptive, should be considered with caution. Consideration should be given to altering the specified material-to-liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test specimen. Additional procedures that fully remove the extract liquid from the test specimen, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and test specimen physical structure should be taken into ...
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.  
1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device.  
1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.  
1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered 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 thi...

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ASTM
ASTM F719-20e1(Practice)
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.  
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.  
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 may involve hazardous materials, operations, and equipment. 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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