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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)

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.

General Information

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

Relations

Refers
ASTM D1356-20a - Standard Terminology Relating to Sampling and Analysis of Atmospheres
Effective Date
01-Sep-2020
Refers
ASTM D1356-20 - Standard Terminology Relating to Sampling and Analysis of Atmospheres
Effective Date
15-Mar-2020

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ASTM E3297-21 - Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)ASTM E3297-21 - Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)
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ASTM E3297-21 - Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)
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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: E3297 − 21
Standard Test Method for
Lipid Quantitation in Liposomal Formulations Using High
Performance Liquid Chromatography (HPLC) with a
1
Charged Aerosol Detector (CAD)
This standard is issued under the fixed designation E3297; 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 priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 This test method is for the separation of lipids in
1.9 This international standard was developed in accor-
liposomal formulations through high performance liquid chro-
dance with internationally recognized principles on standard-
matography (HPLC) and their quantitation using a mass-flow
ization established in the Decision on Principles for the
sensitive charged aerosol detector (CAD).
Development of International Standards, Guides and Recom-
1.2 This test method is specifically for liposomal formula-
mendations issued by the World Trade Organization Technical
tions containing cholesterol, 1,2-distearoyl-sn-glycero-3-
Barriers to Trade (TBT) Committee.
phosphoethanolamine-N-[methoxy(polyethylene glycol)-
2. Referenced Documents
2000] (DSPE-PEG 2000) and hydrogenated soy L-α-
2
phosphatidylcholine (HSPC).
2.1 ASTM Standards:
D1193Specification for Reagent Water
1.3 This test method is applicable to report the absolute
concentrations and ratio of cholesterol, DSPE-PEG 2000, and D1356Terminology Relating to Sampling and Analysis of
Atmospheres
HSPCinliposomalformulations.Assessmentofthestabilityof
the analytes in terms of their degradation profiles as a result of D6026Practice for Using Significant Digits and Data Re-
cords in Geotechnical Data
oxidationorhydrolysisisbeyondthescopeofthistestmethod.
D7439Test Method for Determination of Elements in Air-
1.4 This test method includes calibration standards
borne Particulate Matter by Inductively Coupled Plasma-
preparation, sample preparation, method validation, and
–Mass Spectrometry
sample analysis. This method also contains specifications for
E131Terminology Relating to Molecular Spectroscopy
instrumentation and the chromatography experimental proce-
E177Practice for Use of the Terms Precision and Bias in
dure.
ASTM Test Methods
1.5 The detection limit and quantitation limit for the ana-
E456Terminology Relating to Quality and Statistics
lytes in this test method is in the range of 0.1–2.0 µg/g and
E682Practice for Liquid Chromatography Terms and Rela-
1.0–5.0 µg/g respectively. The analytical measurement range
tionships
for cholesterol, DSPE-PEG 2000, and HSPC is 5–300 µg/g.
E2490Guide for Measurement of Particle Size Distribution
of Nanomaterials in Suspension by Photon Correlation
1.6 All observed and calculated values shall conform to the
Spectroscopy (PCS)
guidelines for significant digits and rounding as established in
E3025Guide for TieredApproach to Detection and Charac-
Practice D6026.
terization of Silver Nanomaterials in Textiles
1.7 Units—The values stated in SI units are to be regarded
E3080Practice for Regression Analysis with a Single Pre-
asthestandard.Whereappropriate,c.g.sunitsinadditiontoSI
dictor Variable
units are included in this standard.
3. Terminology
1.8 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3.1 Definitions:
responsibility of the user of this standard to establish appro-
3.1.1 accuracy, n—closeness of agreement between a test
result and an accepted reference value.
1
This test method is under the jurisdiction of ASTM Committee E56 on
2
Nanotechnology and is the direct responsibility of Subcommittee E56.08 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Nano-Enabled Medical Products. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Dec. 15, 2021. Published April 2022. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
E3297-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3297 − 21
n 2
3.1.1.1 Discussion—The term accuracy, when applied to a
X Y
S D
( i i
set of results, involves a combination of random components
i51
2
r 5 (2)
n n
and a common systematic error or bias component. E177
X Y
S DS D
( i ( i
3.1.2 aerosol, n—su
...

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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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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...
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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.  
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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.
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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).  
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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.
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Standard Guide for Nanotechnology Workforce Education in Material Properties and Effects of Size

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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.  
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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.  
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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.  
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SCOPE
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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.  
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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.

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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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