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ASTM E2865-12(2022)

(Guide)

Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials

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.

General Information

Status
Published
Publication Date
31-Aug-2022
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 E2865-12(2022) - Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological MaterialsASTM E2865-12(2022) - Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
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ASTM E2865-12(2022) - Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
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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: E2865 − 12 (Reapproved 2022)
Standard Guide for
Measurement of Electrophoretic Mobility and Zeta Potential
1
of Nanosized Biological Materials
This standard is issued under the fixed designation E2865; 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 ISO 13099-2 Colloidal Systems — Methods for Zeta-
Potential Determination — Part 2: Optical Methods
1.1 This guide deals with the measurement of mobility and
ISO 13321Particle Size Analysis — Photon Correlation
zetapotentialinsystemscontainingbiologicalmaterialsuchas
Spectroscopy
proteins, DNA, liposomes and other similar organic materials
that possess particle sizes in the nanometer scale (<100 nm).
3. Terminology
1.2 The values stated in SI units are to be regarded as
3.1 Definitions—Definitions of nanotechnology terms can
standard. No other units of measurement are included in this
be found in Terminology E2456.
standard.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 Brownian motion, n—is the random movement of
1.3 This standard does not purport to address all of the
particles suspended in a fluid caused by external bombardment
safety concerns, if any, associated with its use. It is the
by dispersant atoms or molecules.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3.2.2 dielectric constant, n—the relative permittivity of a
mine the applicability of regulatory limitations prior to use.
material for a frequency of zero is known as its dielectric
1.4 This international standard was developed in accor-
constant (or static relative permittivity).
dance with internationally recognized principles on standard-
3.2.2.1 Discussion—Technically,itistheratiooftheamount
ization established in the Decision on Principles for the
of electrical energy stored in a material by an applied voltage,
Development of International Standards, Guides and Recom-
relative to that stored in a vacuum.
mendations issued by the World Trade Organization Technical
3.2.3 electrophoretic mobility, n—the motion of dispersed
Barriers to Trade (TBT) Committee.
particles relative to a fluid under the influence of an electrical
field (usually considered to be uniform).
2. Referenced Documents
3.2.4 isoelectric point, n—point of zero electrophoretic
2
2.1 ASTM Standards:
mobility.
E1470Test Method for Characterization of Proteins by
3
3.2.5 mobility—see electrophoretic mobility.
Electrophoretic Mobility (Withdrawn 2014)
E2456Terminology Relating to Nanotechnology
3.2.6 redox reaction, n—achemicalreactioninwhichatoms
4
2.2 ISO Standards: have their oxidation number (oxidation state) changed.
ISO 13099-1 Colloidal Systems — Methods for Zeta-
3.2.7 stability, n—the tendency for a dispersion to remain in
Potential Determination — Part 1: Electroacoustic and
the same form for an appropriate timescale (for example, the
Electrokinetic Phenomena
experiment duration; on storage at 358K).
3.2.7.1 Discussion—In certain circumstances (for example
water colloid flocculation) instability may be the desired
1
This guide is under the jurisdiction of ASTM Committee E56 on Nanotech-
property.
nology and is the direct responsibility of Subcommittee E56.02 on Physical and
Chemical Characterization.
3.2.8 van der Waals forces, n—in broad terms the forces
Current edition approved Sept. 1, 2022. Published October 2022. Originally
between particles or molecules.
approved in 2012. Last previous edition approved in 2018 as E2865 – 12 (2018).
DOI: 10.1520/E2865-12R22.
3.2.8.1 Discussion—These forces tend to be attractive in
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
nature (because such attractions lead to reduced energy in the
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
system) unless specific steps are undertaken to prevent this
Standards volume information, refer to the standard’s Document Summary page on
attraction.
the ASTM website.
3
The last approved version of this historical standard is referenced on
3.2.9 zeta potential, n—the potential difference between the
www.astm.org.
4
dispersion medium and the stationary layer of fluid attached to
Available from International Organization for Standardization (ISO), 1, ch. de
la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org. the dispersed particle.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken
...

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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.  
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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.  
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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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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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