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ASTM E2859-11(2023)

(Guide)

Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy

Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy

SIGNIFICANCE AND USE
5.1 As AFM measurement technology has matured and proliferated, the technique has been widely adopted by the nanotechnology research and development community to the extent that it is now considered an indispensible tool for visualizing and quantifying structures on the nanoscale. Whether used as a stand-alone method or to complement other dimensional measurement methods, AFM is now a firmly established component of the nanoparticle measurement tool box. International standards for AFM-based determination of nanoparticle size are nonexistent as of the drafting of this guide. Therefore, this standard aims to provide practical and metrological guidance for the application of AFM to measure the size of substrate-supported nanoparticles based on maximum displacement as the probe is rastered across the particle surface to create a line profile.
SCOPE
1.1 The purpose of this document is to provide guidance on the quantitative application of atomic force microscopy (AFM) to determine the size of nanoparticles2 deposited in dry form on flat substrates using height (z-displacement) measurement. Unlike electron microscopy, which provides a two-dimensional projection or a two-dimensional image of a sample, AFM provides a three-dimensional surface profile. While the lateral dimensions are influenced by the shape of the probe, displacement measurements can provide the height of nanoparticles with a high degree of accuracy and precision. If the particles are assumed to be spherical, the height measurement corresponds to the diameter of the particle. In this guide, procedures are described for dispersing gold nanoparticles on various surfaces such that they are suitable for imaging and height measurement via intermittent contact mode AFM. Generic procedures for AFM calibration and operation to make such measurements are then discussed. Finally, procedures for data analysis and reporting are addressed. The nanoparticles used to exemplify these procedures are National Institute of Standards and Technology (NIST) reference materials containing citrate-stabilized negatively charged gold nanoparticles in an aqueous solution.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 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.  
1.4 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.

General Information

Status
Published
Publication Date
31-Aug-2023
ICS
07.120 - Nanotechnologies
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.02 - Physical and Chemical Characterization
Current Stage
Ref Project

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ASTM E2859-11(2023) - Standard Guide for Size Measurement of Nanoparticles Using Atomic Force MicroscopyASTM E2859-11(2023) - Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
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ASTM E2859-11(2023) - Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
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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: E2859 − 11 (Reapproved 2023)
Standard Guide for
Size Measurement of Nanoparticles Using Atomic Force
1
Microscopy
This standard is issued under the fixed designation E2859; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 The purpose of this document is to provide guidance on
mendations issued by the World Trade Organization Technical
the quantitative application of atomic force microscopy (AFM)
2
Barriers to Trade (TBT) Committee.
to determine the size of nanoparticles deposited in dry form on
flat substrates using height (z-displacement) measurement.
2. Referenced Documents
Unlike electron microscopy, which provides a two-dimensional
3
2.1 ASTM Standards:
projection or a two-dimensional image of a sample, AFM
E1617 Practice for Reporting Particle Size Characterization
provides a three-dimensional surface profile. While the lateral
Data
dimensions are influenced by the shape of the probe, displace-
E2382 Guide to Scanner and Tip Related Artifacts in Scan-
ment measurements can provide the height of nanoparticles
ning Tunneling Microscopy and Atomic Force Micros-
with a high degree of accuracy and precision. If the particles
copy
are assumed to be spherical, the height measurement corre-
E2456 Terminology Relating to Nanotechnology
sponds to the diameter of the particle. In this guide, procedures
E2530 Practice for Calibrating the Z-Magnification of an
are described for dispersing gold nanoparticles on various
surfaces such that they are suitable for imaging and height Atomic Force Microscope at Subnanometer Displacement
Levels Using Si(111) Monatomic Steps (Withdrawn
measurement via intermittent contact mode AFM. Generic
4
2015)
procedures for AFM calibration and operation to make such
E2587 Practice for Use of Control Charts in Statistical
measurements are then discussed. Finally, procedures for data
Process Control
analysis and reporting are addressed. The nanoparticles used to
5
exemplify these procedures are National Institute of Standards
2.2 ISO Standards:
and Technology (NIST) reference materials containing citrate-
ISO 18115–2 Surface Chemical Analysis—Vocabulary—
stabilized negatively charged gold nanoparticles in an aqueous
Part 2: Terms Used in Scanning-Probe Microscopy
solution.
ISO/IEC Guide 98–3:2008 Uncertainty of Measurement—
Part 3: Guide to the Expression of Uncertainty in Mea-
1.2 The values stated in SI units are to be regarded as
surement (GUM:1995)
standard. No other units of measurement are included in this
standard.
3. Terminology
1.3 This standard does not purport to address all of the
3.1 Definitions:
safety concerns, if any, associated with its use. It is the
3.1.1 For definitions pertaining to nanotechnology terms,
responsibility of the user of this standard to establish appro-
refer to Terminology E2456.
priate safety, health, and environmental practices and deter-
3.1.2 For definitions pertaining to terms associated with
mine the applicability of regulatory limitations prior to use.
scanning-probe microscopy, including AFM, refer to ISO
1.4 This international standard was developed in accor-
18115–2.
dance with internationally recognized principles on standard-
1
This guide is under the jurisdiction of ASTM Committee E56 on Nanotech-
3
nology and is the direct responsibility of Subcommittee E56.02 on Physical and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Chemical Characterization. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Sept. 1, 2023. Published September 2023. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 2011. Last previous edition approved in 2017 as E2859 – 11 (2017). the ASTM website.
4
DOI: 10.1520/E2859-11R23. The last approved version of this historical standard is referenced on
2
Having two or three dimensions in the size scale from approximately 1 nm to www.astm.org.
5
100 nm as in accordance with Terminology E2456; this definition does not consider Available from International Organization for Standardization (ISO), ISO
functionality, which may impact regulatory aspects of nanotechnology, but which Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
are beyond the scope of this guide. Geneva, Switzerland, h
...

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SIGNIFICANCE AND USE
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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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ASTM
ASTM E3297-21(Test Method)
Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)

SIGNIFICANCE AND USE
5.1 The growing interest in liposomal formulations in the pharmaceutical industry requires QC and thorough characterization and quantification of lipids that form liposomes (6). Lipid composition has proven to be a critical attribute of the liposomal formulation; it directly influences the stability of the formulation, drug loading, performance, size, and surface characteristics of the liposome. Cholesterol plays a key role in controlled drug release by adding stability to the liposome (7). Significant variation in the lipid composition and ratio of the components will influence the safety, biodistribution, drug efficacy, and drug release kinetics of the liposomal formulation (8-11).  
5.2 This test method is a fast and reliable procedure for the quantification of cholesterol, DSPE-PEG 2000, and HSPC in liposomal formulations using HPLC-CAD.  
5.3 This test method can be used for QC and QA and to ascertain variations in component profiling of liposomal formulations.
SCOPE
1.1 This test method is for the separation of lipids in liposomal formulations through high performance liquid chromatography (HPLC) and their quantitation using a mass-flow sensitive charged aerosol detector (CAD).  
1.2 This test method is specifically 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 and ratio of cholesterol, DSPE-PEG 2000, and HSPC in liposomal formulations. Assessment of the stability of the analytes in terms of their degradation profiles as a result of oxidation or hydrolysis is beyond the scope of this test method.  
1.4 This test method includes calibration standards preparation, sample preparation, method validation, and sample analysis. This method also contains specifications for instrumentation and the chromatography experimental procedure.  
1.5 The detection limit and quantitation limit for the analytes in this test method is in the range of 0.1–2.0 µg/g and 1.0–5.0 μg/g respectively. The analytical measurement range for cholesterol, DSPE-PEG 2000, and HSPC is 5–300 µg/g.  
1.6 All observed and calculated values shall conform to the guidelines for significant digits and rounding as established in Practice D6026.  
1.7 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.  
1.8 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 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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