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ASTM E3275-21

(Guide)

Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis

Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis

SIGNIFICANCE AND USE
5.1 The information and recommendations in this guide are relevant for imaging and identifying ENMs in cells and other biological (for example, fixed tissues, whole plants) and nonbiological (for example, drug formulations, filter media, soil, and wastewater) matrices after appropriate sample preparation procedures have been performed (3-5). DFM/HSI is a recently developed analytical tool; however, the relative simplicity of sample preparation combined with the potential to acquire high-contrast ENM images and high-content ENM spectral responses facilitates the increasing use of the tool for diverse applications in drug delivery, toxicology, environmental science, biology, and medicine.  
5.2 Verification of the uptake and spatial distribution of ENMs in cells, for example, is necessary for evaluating and understanding the biological effects of ENMs on living systems. Similarly, the closeness of the spatial distribution of ENMs in complex drug formulations can be an important criterion in establishing physicochemical similarity between formulations (6). Complex products are described in the most recent version of the Generic Drug User Fee Act (GDUFA) reauthorization commitment letter: (7). This guide covers the criteria and general considerations for performing DFM/HSI analyses on samples of biological and nonbiological origins containing ENMs (for example, metal and metal oxide nanoparticles, or carbon nanotubes, or both). This guide does not cover or address provisions for imaging or identifying, or both, non-engineered (natural) nanoparticles/nanomaterials in cells or other matrices, nor does this guide describe or discuss the application of DFM/HSI for determining the dimensions of ENMs.
SCOPE
1.1 This guide has been prepared to familiarize laboratory scientists with the background information and technical content necessary to image and identify engineered nanomaterials (ENMs) in cells via darkfield microscopy/hyperspectral imaging (DFM/HSI) methodology.  
1.2 DFM/HSI is a hyphenated bioanalytical technique/tool that combines optical microscopy with high-resolution spectral imaging to both spatially localize the distribution of and identify ENMs within a suitably prepared test sample.  
1.2.1 In the context of mammalian cells, ENMs will have distinctive light-scattering properties in comparison to subcellular organelles and cell structural features, which can allow one to discriminate between the spectral profiles of ENMs and cellular components.  
1.2.2 The light-scattering properties of ENMs in other test samples, such as fixed tissues, plants, complex drug product formulations, filter media, and so forth, will also be different from the native matrix component scattering signals inherent to these other types of samples, thus allowing for ENM visualization and identification.  
1.3 This guide is applicable to the use of DFM/HSI for identifying ENMs in the matrices mentioned.  
1.4 This guide describes and discusses basic practices for setting up and using DFM/HSI instrumentation, sample imaging techniques, considerations for optics, image analysis, and the use of reference spectral libraries (RSLs). DFM/HSI is routinely used in industry, academia, and government as a research and development and quality control tool in diverse areas of nanotechnology.  
1.5 The values stated in SI units are to be regarded as the 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of Internati...

General Information

Status
Published
Publication Date
31-May-2021
ICS
07.120 - Nanotechnologies
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.08 - Nano-Enabled Medical Products
Current Stage
Ref Project

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ASTM E3275-21 - Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) AnalysisASTM E3275-21 - Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis
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ASTM E3275-21 - Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis
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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:E3275 −21
Standard Guide for
Visualization and Identification of Nanomaterials in
Biological and Nonbiological Matrices Using Darkfield
1
Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis
This standard is issued under the fixed designation E3275; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This guide has been prepared to familiarize laboratory
responsibility of the user of this standard to establish appro-
scientists with the background information and technical con-
priate safety, health, and environmental practices and deter-
tent necessary to image and identify engineered nanomaterials
mine the applicability of regulatory limitations prior to use.
(ENMs) in cells via darkfield microscopy/hyperspectral imag-
1.7 This international standard was developed in accor-
ing (DFM/HSI) methodology.
dance with internationally recognized principles on standard-
1.2 DFM/HSI is a hyphenated bioanalytical technique/tool
ization established in the Decision on Principles for the
thatcombinesopticalmicroscopywithhigh-resolutionspectral
Development of International Standards, Guides and Recom-
imaging to both spatially localize the distribution of and
mendations issued by the World Trade Organization Technical
identify ENMs within a suitably prepared test sample.
Barriers to Trade (TBT) Committee.
1.2.1 In the context of mammalian cells, ENMs will have
distinctive light-scattering properties in comparison to subcel-
2. Referenced Documents
lular organelles and cell structural features, which can allow
2
2.1 ASTM Standards:
one to discriminate between the spectral profiles of ENMs and
E2456Terminology Relating to Nanotechnology
cellular components.
E3255Practice for Quality Assurance of Forensic Science
1.2.2 The light-scattering properties of ENMs in other test
ServiceProvidersPerformingForensicChemicalAnalysis
samples, such as fixed tissues, plants, complex drug product
3
2.2 ISO Standards:
formulations, filter media, and so forth, will also be different
ISO 20473Optics and photonics—Spectral bands
fromthenativematrixcomponentscatteringsignalsinherentto
ISO/TS 80004-1Nanotechnologies—Vocabulary—Part 1:
these other types of samples, thus allowing for ENM visual-
Core terms
ization and identification.
1.3 This guide is applicable to the use of DFM/HSI for
3. Terminology
identifying ENMs in the matrices mentioned.
3.1 Definitions:
1.4 This guide describes and discusses basic practices for
3.1.1 agglomerate, n—group of particles held together by
setting up and using DFM/HSI instrumentation, sample imag-
relatively weak forces (for example, van der Waals or capil-
ing techniques, considerations for optics, image analysis, and
lary) that may break apart into smaller particles upon
the use of reference spectral libraries (RSLs). DFM/HSI is
processing. E2456
routinely used in industry, academia, and government as a
3.1.2 aggregate, n—discrete group of particles in which the
research and development and quality control tool in diverse
various individual components are not easily broken apart,
areas of nanotechnology.
such as the case of primary particles that are strongly bonded
1.5 The values stated in SI units are to be regarded as the
together (for example, fused, sintered, or metallically bonded
standard. No other units of measurement are included in this
particles). E2456
standard.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction of ASTM Committee E56 on Nanotech- contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
nology and is the direct responsibility of Subcommittee E56.08 on Nano-Enabled Standards volume information, refer to the standard’s Document Summary page on
Medical Products. the ASTM website.
3
Current edition approved June 1, 2021. Published July 2021. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
E3275-21. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3275−21
3.1.3 blank sample, n—sample matrix carried through all or 3.1.16 image cube, n—hyperspectral image composed of
part of the analytical process, where
...

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4.1 Natural and manufactured textiles fibers can be treated with chemicals to provide enhanced antimicrobial (fungi, bacteria, viruses) properties. In some cases, silver nanomaterials may be used to treat textile fibers (1).6 Silver nanomaterials are used to treat a wide array of consumer textile products, including, but not limited to, various clothing; primary garments (shirts, pants), outer wear (gloves, jackets), inner wear (socks and underwear), children’s clothing (sleepwear); children’s plush toys; bath towels and bedding (sheets, pillows); and medical devices (for example, wound dressings and face masks) (2).  
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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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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 materials synthesis and processing 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 synthesis and processing 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 practice, 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 materials synthesis and processing at the nanoscale. 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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