ASTM F2103-18 PDF

Full title and description

Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue‑Engineered Medical Product Applications. This guide provides recommended characterization parameters and testing approaches for chitosan salts used as raw materials in biomedical, pharmaceutical, and tissue‑engineered medical product (TEMP) applications, to support material selection, quality control, and regulatory submissions.

Abstract

This guide summarizes key identity, chemical, physical, impurity and performance tests that should be considered when evaluating chitosan salts for biomedical use. Topics include identity and structure (degree of deacetylation), molar mass/molar mass distribution, salt form, residual solvents and impurities, moisture/ash content, viscosity/solution behavior, microbiological quality/endotoxin, and recommended test methods or references to companion ASTM test methods. The intent is to help manufacturers, test laboratories and device developers ensure consistent starting materials for downstream device or drug‑delivery manufacturing.

General information

• Status: Published / active guide (ASTM F2103‑18 edition).
• Publication date: 1 June 2018 (designation F2103‑18).
• Publisher: ASTM International (formerly American Society for Testing and Materials).
• ICS / categories: Laboratory medicine / medical device materials (ICS 11.100; 11.100.99).
• Edition / version: F2103‑18 (2018 edition).
• Number of pages: 9 pages (typical published length).

Scope

This guide covers evaluation and characterization of chitosan salts intended for biomedical and pharmaceutical applications, including tissue‑engineered medical products (TEMPs). It addresses parameters relevant to functionality and purity (identity, degree of deacetylation, molar mass, salt counterion, residuals, moisture/ash, viscosity, microbiological quality, and performance‑related tests) and recommends appropriate analytical methods and considerations for their use as starting materials in device or drug formulations. It does not prescribe product design or clinical use but provides a testing/characterization framework to support material selection, manufacturing controls, and regulatory review.

Key topics and requirements

• Identity and chemical structure — determination of degree of deacetylation (important for functionality and charge).
• Molar mass and distribution — characterization by SEC‑MALS or equivalent methods to support consistency.
• Salt form and counterion specification — e.g., chloride, glutamate, acetate, with effects on solubility and pH.
• Residuals and impurities — residual solvents, heavy metals, ash content, and other organics; appropriate limits and test methods.
• Moisture, viscosity and solution behavior — tests to assess processing reproducibility and performance in formulations.
• Microbial control and endotoxin — bioburden and endotoxin testing for materials intended for implantable or parenteral use.
• Recommended analytical references — cross‑references to ASTM test methods (for example, degree of deacetylation by 1H NMR, molar mass by SEC‑MALS) and other standards.

Typical use and users

Primary users are biomaterials suppliers, quality control and analytical laboratories, medical device and tissue‑engineering product developers, contract testing labs, and regulatory affairs teams preparing material specifications and regulatory submissions. The guide is used when selecting chitosan raw materials, writing material specifications, performing supplier qualification, or designing characterization test plans for TEMPs and related biomedical products.

Related standards

Relevant companion and referenced standards include ASTM F2260 (degree of deacetylation by 1H NMR), ASTM F2602 (molar mass by SEC‑MALS) and other ASTM test methods addressing impurity, moisture and biological testing; ISO standards on biocompatibility and medical device quality systems (for example ISO 10993 series and ISO 13485) are commonly used alongside this guide.

Keywords

chitosan, chitosan salts, TEMPs, tissue‑engineered medical products, biomedical materials, degree of deacetylation, molar mass, SEC‑MALS, 1H NMR, endotoxin, material characterization, ASTM F2103‑18.

FAQ

Q: What is this standard?

A: ASTM F2103‑18 is a Standard Guide that recommends characterization and testing approaches for chitosan salts used as starting materials in biomedical, pharmaceutical, and tissue‑engineered medical product applications.

Q: What does it cover?

A: It covers key material attributes (identity, degree of deacetylation, molar mass, salt form), impurity and residual testing, moisture/ash/viscosity measurements, microbiological/endotoxin considerations, and points to appropriate analytical methods and companion ASTM test methods. It is a guidance document—not a prescriptive specification for finished products.

Q: Who typically uses it?

A: Biomaterials suppliers, device manufacturers, analytical testing labs, and regulatory affairs personnel use the guide to create material specifications, plan characterization testing, and support regulatory submissions for TEMPs and other biomedical products that incorporate chitosan salts.

Q: Is it current or superseded?

A: The F2103‑18 edition was published 1 June 2018 and is the 2018 edition of the guide. Earlier editions (for example the 2011 and 2001 versions) were superseded by the 2018 edition. Users should confirm the current status and any later revisions or corrigenda through ASTM or national standards bodies before relying on the text for regulatory submissions.

Q: Is it part of a series?

A: The guide is part of ASTM’s F04 committee outputs (medical and surgical materials and devices) and is used alongside related ASTM test methods and standards for chitosan characterization and medical device material testing (for example ASTM F2260 and F2602). It is commonly used in conjunction with biocompatibility (ISO 10993) and quality system (ISO 13485) standards.

Q: What are the key keywords?

A: Chitosan, chitosan salts, degree of deacetylation, molar mass, SEC‑MALS, 1H NMR, TEMPs, biomedical materials, impurities, endotoxin, ASTM F2103‑18.