iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM E3247-20

(Test Method)

Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering

Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering

SIGNIFICANCE AND USE
5.1 Particle size is a key property of manufactured or engineered nanoparticles used in a wide range of applications. For purposes relevant to evaluations of safety, effectiveness, performance, quality, public health impact, or regulatory status of products, the correct measurement and uniform reporting of size and related parameters under use conditions, or during the manufacturing process, are critical to suppliers, analysts, regulators and other stakeholders.  
5.2 This test method is intended principally for the analysis of nanoparticles in aqueous suspension with dimensions between about 1 nm and 100 nm, but may be applied to diffusive colloidal particles even if their dimensions fall outside the nanoscale range (up to 1000 nm).  
5.3 For more detailed guidance on DLS measurements, including operational aspects, refer to Appendix X2 of this test method.
Note 1: The user is also referred to Guide E2490, which provides broad guidance for the application of DLS to nanomaterials. Guide E2490 is not required for the implementation of this test method.
SCOPE
1.1 This test method addresses the determination of nanoparticle size (equivalent sphere hydrodynamic diameter) using batch-mode (off-line) dynamic light scattering (DLS) in aqueous suspensions and establishes general procedures that are applicable to many commercial DLS instruments. This test method specifies best practices, including sample preparation, performance verification, data analysis and interpretation, and reporting of results. The document includes additional general information for the analyst, such as recommended settings for specific media, potential interferences, and method limitations. Issues specific to the use of DLS data for regulatory submissions are addressed.  
1.2 The procedures and practices described in this test method, in principle, may be applied to any particles that exhibit Brownian motion and are kinetically stable during the course of a typical experimental time frame. In practice, this includes particles up to about 1000 nm in diameter, subject to limitations as described in the test method.  
1.3 This test method does not provide test specimen preparation procedures for all possible materials and applications, nor does it address synthesis or processing prior to sampling. The test specimen (suspension) preparation procedures should provide acceptable results for a wide range of materials and conditions. The analyst must validate the appropriateness for their particular application.  
1.4 This test method is applicable to DLS instruments that implement correlation spectroscopy. Analysts using instruments based on frequency analysis may still find useful information relevant to many aspects of the measurement process, including limits of applicability and best practices. On-line (flow-mode) DLS measurements are not treated here specifically and may have additional limitations or issues relative to batch-mode operation.  
1.5 Units—The values stated in SI units are to be regarded as standard. Where appropriate, c.g.s. units are given in addition to SI.  
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 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-2020
ICS
07.120 - Nanotechnologies
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.02 - Physical and Chemical Characterization
Current Stage
Ref Project

Buy Standard

ASTM E3247-20 - Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light ScatteringASTM E3247-20 - Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
PreviousNext
Standard
ASTM E3247-20 - Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
English language
22 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

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: E3247 − 20
Standard Test Method for
Measuring the Size of Nanoparticles in Aqueous Media
1
Using Dynamic Light Scattering
This standard is issued under the fixed designation E3247; 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 1.5 Units—The values stated in SI units are to be regarded
as standard. Where appropriate, c.g.s. units are given in
1.1 This test method addresses the determination of nano-
addition to SI.
particle size (equivalent sphere hydrodynamic diameter) using
1.6 This standard does not purport to address all of the
batch-mode (off-line) dynamic light scattering (DLS) in aque-
safety concerns, if any, associated with its use. It is the
ous suspensions and establishes general procedures that are
responsibility of the user of this standard to establish appro-
applicable to many commercial DLS instruments. This test
priate safety, health, and environmental practices and deter-
method specifies best practices, including sample preparation,
mine the applicability of regulatory limitations prior to use.
performance verification, data analysis and interpretation, and
1.7 This international standard was developed in accor-
reporting of results. The document includes additional general
dance with internationally recognized principles on standard-
information for the analyst, such as recommended settings for
ization established in the Decision on Principles for the
specific media, potential interferences, and method limitations.
Development of International Standards, Guides and Recom-
Issues specific to the use of DLS data for regulatory submis-
mendations issued by the World Trade Organization Technical
sions are addressed.
Barriers to Trade (TBT) Committee.
1.2 The procedures and practices described in this test
2. Referenced Documents
method, in principle, may be applied to any particles that
2
exhibit Brownian motion and are kinetically stable during the
2.1 ASTM Standards:
course of a typical experimental time frame. In practice, this
E1617Practice for Reporting Particle Size Characterization
includes particles up to about 1000 nm in diameter, subject to
Data
limitations as described in the test method.
E2490Guide for Measurement of Particle Size Distribution
of Nanomaterials in Suspension by Photon Correlation
1.3 This test method does not provide test specimen prepa-
Spectroscopy (PCS)
ration procedures for all possible materials and applications,
E2456Terminology Relating to Nanotechnology
nor does it address synthesis or processing prior to sampling.
E3144Guide for Reporting the Physical and Chemical
The test specimen (suspension) preparation procedures should
Characteristics of Nano-Objects
provide acceptable results for a wide range of materials and
E3206Guide for Reporting the Physical and Chemical
conditions. The analyst must validate the appropriateness for
Characteristics of a Collection of Nano-Objects
their particular application.
3
2.2 ISO Standards:
1.4 This test method is applicable to DLS instruments that
ISO 22412Particle size analysis—Dynamic light scattering
implement correlation spectroscopy. Analysts using instru- (DLS)
ments based on frequency analysis may still find useful
3. Terminology
information relevant to many aspects of the measurement
process, including limits of applicability and best practices.
3.1 Definitions:
On-line (flow-mode) DLS measurements are not treated here
3.1.1 aliquot, n—a representative portion of a whole, as-
specifically and may have additional limitations or issues
sumed to be taken with negligible sampling error. adapted
relative to batch-mode operation.
from ISO 11074
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This test method is under the jurisdiction of ASTM Committee E56 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Nanotechnology and is the direct responsibility of Subcommittee E56.02 on Standards volume information, refer to the standard’s Document Summary page on
Physical and Chemical Characterization. the ASTM website.
3
Current edition approved Sept. 1, 2020. Published October 2020. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
E3247-20. 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 ----------------
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM E2859-11(2023)(Guide)
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.

  • Guide
    9 pages
    English language
    sale 15% off
ASTM
ASTM E3025-22(Guide)
Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles

SIGNIFICANCE AND USE
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).  
4.2 There are many different chemical and physical forms of silver that are used to treat textiles and an overview of this topic is provided in Appendix X1.  
4.3 Several applicable techniques for detection and characterization of silver are listed and described in Appendix X2 so that users of this guide may understand the suitability of a particular technique for their specific textile and silver measurement need.  
4.4 There are many different reasons to assay for silver nanomaterials in a textile at any point in a product’s life cycle. For example, a producer may want to verify that a textile meets their internal quality control specifications or a regulator may want to understand the properties of silver nanomaterials used to make a consumer textile product under their jurisdiction or what quantity of silver nanomaterial is potentially available for release from the treated textile during the washing process or during product use. Regardless of the specific reason, a structured approach to detect and characterize silver nanomaterials present in a textile will facilitate measurements and data comparison. Detection and characterterization of silver in textiles is one component of an overall risk assessment.  
4.5 The approach presented in this guide (see Fig. 1) consists of three sequential tiers: obtain a textile sample (Section 7), detection o...
SCOPE
1.1 This guide covers the use of a tiered approach for detection and characterization of silver nanomaterials in consumer textile products, which can include some medical devices (for example, wound dressings or face masks), made of any combination of natural or manufactured fibers.  
1.2 This guide covers, but is not limited to, fabrics and parts (for example, thread, batting) used during the manufacture of textiles and production of consumer textile products that may contain silver-based nanomaterials. It does not apply to analysis of silver nanomaterials in non-consumer textile product matrices nor does it cover thin film silver coatings with only one dimension in the nanoscale.  
1.3 This guide is intended to serve as a resource for manufacturers, producers, analysts, policymakers, regulators, and others with an interest in textiles.  
1.4 This guide is presented in the specific context of measurement of silver nanomaterials; however, the structured approach described herein is applicable to other nanomaterials in consumer textile products, including some medical devices.  
1.5 Units—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, 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 International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    11 pages
    English language
    sale 15% off
  • Guide
    11 pages
    English language
    sale 15% off
ASTM
ASTM E2864-18(2022)(Test Method)
Standard Test Method for Measurement of Airborne Metal Oxide Nanoparticle Surface Area Concentration in Inhalation Exposure Chambers using Krypton Gas Adsorption

SIGNIFICANCE AND USE
5.1 A tiered strategy for characterization of nanoparticle properties is necessary to draw meaningful conclusions concerning dose-response relationships observed during inhalation toxicology experiments. This tiered strategy includes characterization of nanoparticles as produced (that is, measured as the bulk material sold by the supplier) and as administered (that is, measured at the point of delivery to a test subject) (Oberdorster et al. (6)).  
5.2 Test Methods B922 and C1274 and ISO 9277 and ISO 18757 exist for determination of the as produced surface area of bulk metal and metal oxide powders. During the delivery of nanoparticles in inhalation exposure chambers, the material properties may undergo change and therefore have properties that differ from the material as produced. This test method describes the determination of the as administered surface area of airborne metal oxide nanoparticles in inhalation exposure chambers for inhalation toxicology studies.
SCOPE
1.1 This test method covers determination of surface area of airborne metal oxide nanoparticles in inhalation exposure chambers for inhalation toxicology studies. Surface area may be measured by gas adsorption methods using adsorbates such as nitrogen, krypton, and argon (Brunauer et al. (1),2 Anderson (2), Gregg and Sing (3)) or by ion attachment and mobility-based methods (Ku and Maynard (4)). This test method is specific to the measurement of surface area by gas adsorption by krypton gas adsorption. The test method permits the use of any modern commercial krypton adsorption instruments but strictly defines the sample collection, outgassing, and analysis procedures for metal and metal oxide nanoparticles. Use of krypton is required due to the low overall surface area of particle-laden samples and the need to accurately measure the background surface area of the filter used for sample collection. Instrument-reported values of surface area based on the multipoint Brunauer, Emmett and Teller (BET) equation (Brunauer et al. (1), Anderson (2), Gregg and Sing (3)) are used to calculate surface area of airborne nanoparticles collected on a filter.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. State all numerical values in terms of SI units unless specific instrumentation software reports surface area using alternate units.  
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.

  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM E3323-22(Test Method)
Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)

SIGNIFICANCE AND USE
5.1 Lipid composition in a liposomal formulation is an important aspect during synthesis of liposomes, which determines stability, surface characteristics, drug encapsulation, and drug release capabilities. The cholesterol component plays a key role in controlled drug release by adding stability to the liposome. A small variation in the lipid composition can significantly alter the parameters mentioned above (15).  
5.2 Variation in the lipid composition in the liposomal formulation may influence the safety and efficacy of the product. Therefore, chemical composition of the liposomes shall be determined.  
5.3 The pharmaceutical industry and regulatory agencies require QC, QA, specifications, thorough characterization, and quantification of lipid components (16, 17).  
5.4 This test method can be used to ascertain variations in the lipid component profiling of various liposomal formulations. However, this test method does not intend to identify chemical degradation products (18).  
5.5 Analyzing the stability of analytes and their chemical degradation profiles as a result of oxidation or hydrolysis is beyond the scope of this test method (18, 19).
SCOPE
1.1 This test method describes an analytical technique to quantify lipid components that are often present in liposomal formulations as major components.  
1.2 This test method uses high performance liquid chromatography (HPLC) to separate lipids in liposomal formulations and evaporative light-scattering detection (ELSD) to quantify the individual components.  
1.3 This test method quantifies three major organic components in liposomal formulations: cholesterol, 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethylene glycol)-2000] (DSPE-PEG 2000), and hydrogenated soy L-α-phosphatidylcholine (HSPC).  
1.4 This test method can estimate the absolute concentration of cholesterol, DSPE-PEG 2000, and HSPC and their ratio (DSPE-PEG 2000: HSPC: cholesterol) in liposomal formulations.  
1.5 This test method describes preparation of calibration standards and samples, HPLC and ELSD instrumentation, method development and method validation, sample analysis, and data reporting.  
1.6 The detection limits and quantitation limits for the analytes (lipid components) in this test method are in the range of 2 µg/g to 4 µg/g and 7 µg/g to 10 μg/g, respectively. The analytical measurement ranges for cholesterol, DSPE-PEG 2000, and HSPC are 10 µg/g to 165 µg/g, 10 µg/g to 300 µg/g, and 10 µg/g to 200 µg/g, respectively.  
1.7 Significant digits and rounding of all reported values have been performed according to the guidelines 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 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.  
1.10 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.

  • Standard
    20 pages
    English language
    sale 15% off
  • Standard
    20 pages
    English language
    sale 15% off
ASTM
ASTM E2865-12(2022)(Guide)
Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials

SCOPE
1.1 This guide deals with the measurement of mobility and zeta potential in systems containing biological material such as proteins, DNA, liposomes and other similar organic materials that possess particle sizes in the nanometer scale (  
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.

  • Guide
    7 pages
    English language
    sale 15% off
ASTM
ASTM E2834-12(2022)(Guide)
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)

SIGNIFICANCE AND USE
5.1 NTA is one of the very few techniques that are able to deal with the measurement of particle size distribution in the nano-size region. This guide describes the NTA technique for direct visualization and measurement of Brownian motion, generally applicable in the particle size range from several nanometers until the onset of sedimentation in the sample. The NTA technique is usually applied to dilute suspensions of solid material in a liquid carrier. It is a first principles method (that is, calibration in the standard understanding of this word, is not involved). The measurement is hydrodynamically based and therefore provides size information in the suspending medium (typically water). Thus the hydrodynamic diameter will almost certainly differ from size diameters determined by other techniques and users of the NTA technique need to be aware of the distinction of the various descriptors of particle diameter before making comparisons between techniques (see 8.7). Notwithstanding the preceding sentence, the technique is routinely applied in industry and academia as both a research and development tool and as a QC method for the characterization of submicron systems.
SCOPE
1.1 This guide deals with the measurement of particle size distribution of suspended particles, from ~10 nm to the onset of sedimentation, sample dependent, using the nanoparticle tracking analysis (NTA) technique. It does not provide a complete measurement methodology for any specific nanomaterial, but provides a general overview and guide as to the methodology that should be followed for good practice, along with potential pitfalls.  
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.

  • Guide
    11 pages
    English language
    sale 15% off
ASTM
ASTM E3089-22(Guide)
Standard Guide for Nanotechnology Workforce Education in Material Properties and Effects of Size

SIGNIFICANCE AND USE
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.

  • Guide
    4 pages
    English language
    sale 15% off
  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM E3071-22(Guide)
Standard Guide for Nanotechnology Workforce Education in Materials Synthesis and Processing

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.  
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 a complement of topics related to the infrastructure required for advanced research and manufacturing, 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 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.

  • Guide
    4 pages
    English language
    sale 15% off
  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM E3059-22(Guide)
Standard Guide for Workforce Education in Nanotechnology Infrastructure

SIGNIFICANCE AND USE
5.1 The purpose of this guide is to provide, at the undergraduate college level, a basic educational structure in the infrastructure aspects of nanotechnology 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.  
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 a complement of topics related to the infrastructure required for advanced research and manufacturing, 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 document provides guidelines for basic workforce education in the infrastructure topics related to nanotechnology to be taught at an undergraduate college level. This education should be broad to prepare an individual to work within one of the many areas in nanotechnology research, development, or manufacturing. The individual so educated may be involved in material handling, manufacture, distribution, storage, use, or disposal of nanoscale materials.  
1.2 This guide may be used to develop or evaluate an education program for the infrastructure used 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 methods and concepts pertaining to the infrastructure for nanotechnology. It may not cover knowledge and skill objectives 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.

  • Guide
    4 pages
    English language
    sale 15% off
  • Guide
    4 pages
    English language
    sale 15% off
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...

  • Standard
    20 pages
    English language
    sale 15% off