ASTM F2103-11
(Guide)Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
SIGNIFICANCE AND USE
This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities.
The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting 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.
To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.
SCOPE
1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.
1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.
1.4 WarningMercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F2103 − 11
Standard Guide for
Characterization and Testing of Chitosan Salts as Starting
Materials Intended for Use in Biomedical and Tissue-
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2103; 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.
INTRODUCTION
Biopolymers from marine sources have been studied and used in commercial applications and
product development for a number of years. Chitosan, a linear polysaccharide consisting of
glucosamine and N-acetyl glucosamine derived mainly from crustacean shells, has been used in many
technical applications such as water purification (as a flocculant), in cosmetics, and recently as a
proposed fat-binding weight control product. In solution, the cationic nature of chitosan gives this
polymer a mucoadhesive property. Chitosan salts can be used as a matrix or scaffold material as well
as in non-parenteral delivery systems for challenging drugs. Chitosan salts have been shown to
increase the transport of polar drugs across the nasal epithelial surface. The purpose of this guide is
to identify key parameters relevant for the functionality and characterization of chitosan salts for the
development of new commercial applications of chitosan salts for the biomedical and pharmaceutical
industries.
1. Scope mercury-containing products. See the applicable product Ma-
terial Safety Data Sheet (MSDS) for details and EPA’s website
1.1 This guide covers the evaluation of chitosan salts
(http://www.epa.gov/mercury/faq.htm) for additional informa-
suitable for use in biomedical or pharmaceutical applications,
tion. Users should be aware that selling mercury or mercury-
or both, including, but not limited to, tissue-engineered medi-
containingproducts,orboth,inyourstatemaybeprohibitedby
cal products (TEMPS).
state law.
1.2 This guide addresses key parameters relevant for the
1.5 The values stated in SI units are to be regarded as
functionality, characterization, and purity of chitosan salts.
standard. No other units of measurement are included in this
1.3 As with any material, some characteristics of chitosan
standard.
may be altered by processing techniques (such as molding,
1.6 This standard does not purport to address all of the
extrusion, machining, assembly, sterilization, and so forth)
safety concerns, if any, associated with its use. It is the
required for the production of a specific part or device.
responsibility of the user of this standard to establish appro-
Therefore, properties of fabricated forms of this polymer
priate safety and health practices and determine the applica-
should be evaluated using test methods that are appropriate to
bility of regulatory limitations prior to use.
ensure safety and efficacy.
1.4 Warning—Mercury has been designated by EPA and
2. Referenced Documents
many state agencies as a hazardous material that can cause
2
2.1 ASTM Standards:
central nervous system, kidney, and liver damage. Mercury, or
D2196 Test Methods for Rheological Properties of Non-
its vapor, may be hazardous to health and corrosive to
Newtonian Materials by Rotational (Brookfield type)
materials.Cautionshouldbetakenwhenhandlingmercuryand
Viscometer
F619 Practice for Extraction of Medical Plastics
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.42 on Biomaterials and Biomolecules for TEMPs. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 1, 2011. Published March 2011. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ε2
approved in 2001. Last previous edition approved in 2007 as F2103 – 01(2007) . Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F2103-11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2103 − 11
F748 PracticeforSelectingGenericBiologicalTestMethods International Conference on Harmonization (1996) Guide-
for Materials and Devices line for Industry S2A Specific Aspects of Regulatory
6
F749 Practice for Evaluating Material Extracts by Intracuta- Genotoxicity Tests for Pharmaceuticals 61 FR 18199
neous Injection in the Rabbit International Conference on Harmonization (1997) Guid-
F756 Practice for Assessment of Hemolytic Properties of ance for Industry S2B Genotoxicity: A Standard Battery
Materials for Genoto
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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.
´2
Designation:F2103–01 (Reapproved 2007) Designation:F2103–11
Standard Guide for
Characterization and Testing of Chitosan Salts as Starting
Materials Intended for Use in Biomedical and Tissue-
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2103; 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
´ NOTE—Formatting and grammar were corrected editorially throughout in April 2007.
2
´ NOTE—Mercury warning was editorially added in April 2008.
INTRODUCTION
Biopolymers from marine sources have been studied and used in commercial applications and
product development for a number of years. Chitosan, a linear polysaccharide consisting of
glucosamine and N-acetyl glucosamine derived mainly from crustacean shells, has been used in many
technical applications such as water purification (as a flocculant), in cosmetics, and recently as a
proposed fat-binding weight control product. In solution, the cationic nature of chitosan gives this
polymer a mucoadhesive property. Chitosan salts can be used as a matrix or scaffold material as well
as in non-parenteral delivery systems for challenging drugs. Chitosan salts have been shown to
increase the transport of polar drugs across the nasal epithelial surface. The purpose of this guide is
to identify key parameters relevant for the functionality and characterization of chitosan salts for the
development of new commercial applications of chitosan salts for the biomedical and pharmaceutical
industries.
1. Scope
1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both,
including, but not limited to, tissue-engineered medical products (TEMPS).
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.
1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion,
machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of
fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central
nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution
should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet
(MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware
that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.5
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 and health practices and determine the applicability of regulatory
limitations prior to use.
1
This guide 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.
Current edition approved Feb. 1, 2007. Published February 2007. Originally approved in 2001. Last previous edition approved in 2001 as F2103–01. DOI:
10.1520/F2103-01R07E02.
´2
Current edition approved March 1, 2011. Published March 2011. Originally approved in 2001. Last previous edition approved in 2007 as F2103 – 01(2007) . DOI:
10.1520/F2103-11.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2103–11
2. Referenced Documents
2
2.1 ASTM Standards:
D2196 Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational (Brookfield type) Viscometer
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Mat
...
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