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ASTM E3206-19

(Guide)

Standard Guide for Reporting the Physical and Chemical Characteristics of a Collection of Nano-Objects

Standard Guide for Reporting the Physical and Chemical Characteristics of a Collection of Nano-Objects

SIGNIFICANCE AND USE
5.1 A nano-object is an individual, well-defined, and separable piece of a nanomaterial; in practice, nanomaterials used in research, products, testing, and other uses are almost always collections of nano-objects. Individual nano-objects and collections of nano-objects are the two major types of nanomaterials in use. The description of a collection of nano-objects is covered in this guide. The description of an individual nano-object is covered in Guide E3144. Nano-objects, individually or as a collection, are often embedded in other materials for commercial, research, and other uses. These embedded nanomaterials can be described using the information categories and descriptors included in these guides.  
5.2 Nanomaterials are of growing importance in research and commerce, and data on their physical and chemical characteristics are critical to predict performance, to transact commercial activities, to assess their potential for harm to human and animal health and the environment in general, and to support regulations that affect their use. A collection of nano-objects is the predominant type of nanomaterial tested and used in commerce.  
5.3 The four types of data and information used to describe a collection of nano-objects are: physical and chemical characteristics; production; specifications; and general identifiers (names and classifications), as shown in Fig. 1.  
FIG. 1 Data and Information Types Necessary to Describe a Collection of Nano-Objects
Used with permission of CODATA from “Uniform Description System for Materials on the Nanoscale,” Version 2.0, http://doi.org/10.5281/zenodo.56720.  
5.4 This guide deals solely with data and information to describe the physical and chemical characterization of a collection of individual nano-objects.
Note 2: Other guides and documents (see Section 2, Referenced Documents) deal with the data and information for production, specifications, and general identifiers (names and classifications).
Note 3: Specifi...
SCOPE
1.1 This guide provides guidelines for a description system to report the physical and chemical characteristics of collections of nano-objects. It establishes information categories and descriptors useful in describing collections of nano-objects uniquely and such that the equivalency of two or more collections of nano-objects can be determined according to specific criteria.  
1.2 This guide is designed to be directly applicable to reporting the physical and chemical characteristics of collections of nano-objects in most circumstances, including, but not limited to, reporting original research results in the archival literature, developing ontologies, database schemas, data repositories, and data reporting formats, specifying regulations, and enabling commercial activity.  
1.3 This guide is applicable to collections of naturally occurring, engineered, and manufactured nano-objects.  
1.4 One goal of the guide is to help ensure that when measurement results are reported, they are reported uniformly.  
1.5 A second goal of the guide is to encourage reports on the properties and functionalities of a collection of nano-objects to include as much detail as possible about the physical and chemical characteristics of that collection so it is uniquely specified.  
1.6 This guide does not cover the chemical reactions or reactivity of a collection of nano-objects.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 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.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization establishe...

General Information

Status
Published
Publication Date
14-Nov-2019
ICS
07.120 - Nanotechnologies
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.01 - Informatics and Terminology
Current Stage
Ref Project

Relations

Refers
ASTM D16-14 - Standard Terminology for Paint, Related Coatings, Materials, and Applications
Effective Date
01-Dec-2014
Refers
ASTM E3172-18 - Standard Guide for Reporting Production Information and Data for Nano-Objects
Effective Date
01-Jun-2018
Refers
ASTM D16-16 - Standard Terminology for Paint, Related Coatings, Materials, and Applications
Effective Date
01-Jul-2016
Refers
ASTM E3144-19 - Standard Guide for Reporting the Physical and Chemical Characteristics of Nano-Objects
Effective Date
01-Sep-2019
Referred By
ASTM E3247-20 - Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
Effective Date
15-Nov-2019

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ASTM E3206-19 - Standard Guide for Reporting the Physical and Chemical Characteristics of a Collection of Nano-ObjectsASTM E3206-19 - Standard Guide for Reporting the Physical and Chemical Characteristics of a Collection of Nano-Objects
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ASTM E3206-19 - Standard Guide for Reporting the Physical and Chemical Characteristics of a Collection of Nano-Objects
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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: E3206 − 19
Standard Guide for
Reporting the Physical and Chemical Characteristics of a
1
Collection of Nano-Objects
This standard is issued under the fixed designation E3206; 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 responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 This guide provides guidelines for a description system
mine the applicability of regulatory limitations prior to use.
to report the physical and chemical characteristics of collec-
1.9 This international standard was developed in accor-
tions of nano-objects. It establishes information categories and
dance with internationally recognized principles on standard-
descriptors useful in describing collections of nano-objects
ization established in the Decision on Principles for the
uniquely and such that the equivalency of two or more
Development of International Standards, Guides and Recom-
collections of nano-objects can be determined according to
mendations issued by the World Trade Organization Technical
specific criteria.
Barriers to Trade (TBT) Committee.
1.2 This guide is designed to be directly applicable to
reporting the physical and chemical characteristics of collec-
2. Referenced Documents
tions of nano-objects in most circumstances, including, but not
2
2.1 ASTM Standards:
limited to, reporting original research results in the archival
D16 TerminologyforPaint,RelatedCoatings,Materials,and
literature, developing ontologies, database schemas, data
Applications
repositories,anddatareportingformats,specifyingregulations,
E2456 Terminology Relating to Nanotechnology
and enabling commercial activity.
E3172 Guide for Reporting Production Information and
1.3 This guide is applicable to collections of naturally
Data for Nano-Objects
occurring, engineered, and manufactured nano-objects.
E3144 Guide for Reporting the Physical and Chemical
Characteristics of Nano-Objects
1.4 One goal of the guide is to help ensure that when
3
2.2 ISO Standards:
measurement results are reported, they are reported uniformly.
ISO 26824:2013(en) Particle Characterization of Particulate
1.5 Asecondgoaloftheguideistoencouragereportsonthe
Systems – Vocabulary
properties and functionalities of a collection of nano-objects to
ISO/TS 12805:2011(en) Nanotechnologies – Materials
include as much detail as possible about the physical and
Specifications – Guidance on Specifying Nano-Objects
chemical characteristics of that collection so it is uniquely
ISO/TS 80004-1:2015(en) Nanotechnologies –Vocabulary –
specified.
Part 1: Core Terms
1.6 This guide does not cover the chemical reactions or
2.3 Other Documents:
reactivity of a collection of nano-objects.
The Uniform Description System for Materials on the
Nanoscale CODATA-VAMAS Working Group on the De-
1.7 The values stated in SI units are to be regarded as
4
scription of Nanomaterials, as released on 25 May 2016
standard. No other units of measurement are included in this
standard.
1.8 This standard does not purport to address all of the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
safety concerns, if any, associated with its use. It is the
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 International Organization for Standardization (ISO), ISO
1
This guide is under the jurisdiction of ASTM Committee E56 on Nanotech- Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
nology and is the direct responsibility of Subcommittee E56.01 on Informatics and Geneva, Switzerland, http://www.iso.org.
4
Terminology. Available from Committee on Data (CODATA) International Science Council,
Current edition approved Nov. 15, 2019. Published December 2019. DOI: 5 rue Auguste Vacquerie, 75016 Paris, France, https://www.codata.org/
10.1520/E3206-19. nanomaterials.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3206 − 19
3. Terminology 3.3.3 collection of nano-objects, n—two or more nano-
objects that are associated in some way.
3.1 Definitions—Fordefinitionsofgeneraltermsusedinthis
3.3.3.1 Discussion—The nano-objects in a collection can be
standard, see ASTM Online
...

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SCOPE
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1.6 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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SIGNIFICANCE AND USE
5.1 The purpose of this guide is to provide, at the undergraduate college level, a basic educational structure in the synthesis and processing of nanoscale materials to organizations developing or carrying out education programs for the nanotechnology workforce. This guide helps to describe the minimum knowledge base for anyone involved in nanomanufacturing or nanomaterials research.  
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SCOPE
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5.1 This guide establishes, at the undergraduate college level, the basic education structure for understanding the unique properties and applications of nanoscale materials as compared to bulk properties and applications of macroscale materials. It helps to describe the minimum knowledge base for anyone involved in nanomanufacturing or nanomaterials research and can be used by organizations developing or carrying out education programs for the nanotechnology workforce.  
5.2 The basic education should prepare an individual for varied roles in the nanotechnology workplace. The material in this guide may require a post-secondary two-year science or technology background to be understood sufficiently.  
5.3 Workers may transition in their roles in the workplace. Participants in such education will have a broad understanding of material properties and the effects of size, thus increasing their marketability for jobs within as well as beyond the nanotechnology field.  
5.4 Because nanotechnology is a rapidly developing field, the individual educated in nanotechnology needs to be cognizant of changing and evolving safety procedures and practices. Individuals should be aware of how to maintain an up-to-date understanding of the technology and have sufficient base education to enable the synthesis of emerging or evolving safety procedures and practices.  
5.5 This guide is intended to be one in a series of standards developed for workforce education in various aspects of nanotechnology. It will assist in providing an organization a basic structure for developing a program applicable to many areas in nanotechnology, thus providing dynamic and evolving workforce education.
SCOPE
1.1 This guide provides a framework for a basic workforce education in material properties at the nanoscale, to be taught at an undergraduate college level. This education should be broad to prepare an individual to serve within one of the many areas in nanotechnology research, development, or manufacturing.  
1.2 This guide may be used to develop or evaluate an education program for unique material properties and their applications in the nanotechnology field. This guide provides listings of key topics that should be covered in a nanotechnology education program on this subject, but it does not provide specific course material to be used in such a program. This approach is taken in order to allow workforce education entities to ensure their programs cover the required material while also enabling these institutions to tailor their programs to meet the needs of their local employers.  
1.3 While no units of measurements are used in this guide, values stated in SI units are to be regarded as standard.  
1.4 This standard does not purport to address all of the techniques, materials, and concepts needed for material properties and applications. It is the responsibility of the user of this standard to utilize other knowledge and skill objectives as applicable to local conditions or required by local regulations.  
1.5 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.  
1.6 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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ASTM
ASTM E3324-22(Test Method)
Standard Test Method for Lipid Quantitation in Liposomal Formulations Using Ultra-High-Performance Liquid Chromatography (UHPLC) with Triple Quadrupole Mass Spectrometry (TQMS)

SIGNIFICANCE AND USE
5.1 Liposomes are vesicles of nanoscale dimensions, composed of lipid bilayers, which are used for various diagnostic and therapeutic applications (9). The growing interest in liposomal formulations in the delivery of various drugs, antisense oligonucleotides, cloned genes, or recombinant proteins by the biopharmaceutical industry, warrants QC and thorough characterization of the constituent lipids. Lipid structure, composition, and concentration are key attributes in determining the quality and efficacy of a liposomal drug product as they influence the stability of liposomes, drug loading, release kinetics, biodistribution, and pharmacokinetic properties (9). Cholesterol modulates the lipid membrane fluidity, elasticity, and permeability; hence, it plays a key role in controlled drug release and increased stability of the liposome (10).  
5.2 This test method provides a rapid and reliable protocol for the determination of cholesterol, DSPE-PEG 2000, and HSPC in liposomal formulations using UHPLC-TQMS. Assessment of the stability of the analytes in terms of their degradation profiles is not included in this test method (11). This test method will benefit the biopharmaceutical industry in ascertaining quality assessment of liposomal formulations and monitoring batch-to-batch consistency for large-scale production, thereby facilitating safe and efficient drug development and regulatory review.  
5.3 UHPLC-MS/MS measurements are analytically more sensitive and specific for lipid analysis compared to other contemporary techniques using universal detectors, such as a charged aerosol or an evaporative light-scattering detector. For liposomes, MS/MS has further advantages over ultraviolet detectors, as lipids lack chromophores for detection. In this test method, TQMS has been used as the MS/MS technique of choice because of its high selectivity, sensitivity, S/N, accuracy, and broad linear range of quantitation, thereby allowing reproducible quantitation of the analytes,...
SCOPE
1.1 This test method describes the determination of lipid components in liposomal formulations, which includes sample solubilization in methanol followed by separation of the analytes using ultra-high-performance liquid chromatography (UHPLC) and detection with tandem mass-spectrometry (MS/MS). This test method adheres to multiple reaction monitoring (MRM) mass spectrometry on a triple quadrupole mass spectrometer (TQMS).  
1.2 This test method is specific for liposomal formulations containing cholesterol, 1,2- distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy (polyethylene glycol)-2000] (DSPE- PEG 2000), and hydrogenated (soy) L-α-phosphatidylcholine (HSPC).  
1.3 This test method is applicable to report the absolute concentrations of cholesterol, DSPE-PEG 2000, and HSPC and their ratio (DSPE-PEG 2000: HSPC: cholesterol) in liposomal formulations. Assessment of the stability of the analytes in terms of their degradation as a result of oxidation or hydrolysis is beyond the scope of this test method.  
1.4 This test method includes calibration and standardization, sample preparation, UHPLC-TQMS instrumentation, potential interferences, method validation with acceptance criteria, sample analysis, and data reporting.  
1.5 The detection limits for cholesterol, DSPE-PEG 2000, and HSPC using this test method are 5.3, 0.5, and 0.5 ng/g, respectively. In addition, the quantitation limits for cholesterol, DSPE-PEG 2000, and HSPC are 10.6, 0.8, and 0.5 ng/g, respectively.  
1.6 This test method is intended for concentration ranges of 8-1600 ng/g for cholesterol, and of 2-400 ng/g for DSPE-PEG 2000 and HSPC.  
1.7 All observed and calculated values shall conform to the guidelines for significant digits and rounding as established in Practice D6026.  
1.8 Units—The values stated in SI units are to be regarded as the standard. Where appropriate, c.g.s units in addition to SI units are included in this standard.  
1.9 Th...

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