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ASTM E3323-21

(Test Method)

Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)

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 to 4 µg/g and 7 to 10 μg/g, respectively. The analytical measurement ranges for cholesterol, DSPE-PEG 2000, and HSPC are 10 to 165 µg/g, 10 to 300 µg/g, and 10 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.

General Information

Status
Historical
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

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ASTM E3323-21 - Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)ASTM E3323-21 - Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)
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ASTM E3323-21 - Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E3323 − 21
Standard Test Method for
Lipid Quantitation in Liposomal Formulations Using High
Performance Liquid Chromatography (HPLC) with an
1
Evaporative Light-Scattering Detector (ELSD)
This standard is issued under the fixed designation E3323; 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 1.9 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This test method describes an analytical technique to
responsibility of the user of this standard to establish appro-
quantify lipid components that are often present in liposomal
priate safety, health, and environmental practices and deter-
formulations as major components.
mine the applicability of regulatory limitations prior to use.
1.2 This test method uses high performance liquid chroma-
1.10 This international standard was developed in accor-
tography (HPLC) to separate lipids in liposomal formulations
dance with internationally recognized principles on standard-
and evaporative light-scattering detection (ELSD) to quantify
ization established in the Decision on Principles for the
the individual components.
Development of International Standards, Guides and Recom-
1.3 This test method quantifies three major organic compo-
mendations issued by the World Trade Organization Technical
nentsinliposomalformulations:cholesterol,1,2-distearoyl-sn-
Barriers to Trade (TBT) Committee.
glycero-3-phosphoethanolamine-N-[methoxy(polyethylene
glycol)-2000] (DSPE-PEG 2000), and hydrogenated soy L-α-
2. Referenced Documents
phosphatidylcholine (HSPC).
2
2.1 ASTM Standards:
1.4 Thistestmethodcanestimatetheabsoluteconcentration
D1193Specification for Reagent Water
of cholesterol, DSPE-PEG 2000, and HSPC and their ratio
D1356Terminology Relating to Sampling and Analysis of
(DSPE-PEG 2000: HSPC: cholesterol) in liposomal formula-
Atmospheres
tions.
D6026Practice for Using Significant Digits and Data Re-
1.5 This test method describes preparation of calibration
cords in Geotechnical Data
standards and samples, HPLC and ELSD instrumentation,
D7439Test Method for Determination of Elements in Air-
method development and method validation, sample analysis,
borne Particulate Matter by Inductively Coupled Plasma-
and data reporting.
–Mass Spectrometry
E131Terminology Relating to Molecular Spectroscopy
1.6 The detection limits and quantitation limits for the
E177Practice for Use of the Terms Precision and Bias in
analytes(lipidcomponents)inthistestmethodareintherange
ASTM Test Methods
of 2 to 4 µg/g and 7 to 10 µg/g, respectively. The analytical
E456Terminology Relating to Quality and Statistics
measurement ranges for cholesterol, DSPE-PEG 2000, and
E682Practice for Liquid Chromatography Terms and Rela-
HSPC are 10 to 165 µg/g, 10 to 300 µg/g, and 10 to 200 µg/g,
tionships
respectively.
E2490Guide for Measurement of Particle Size Distribution
1.7 Significant digits and rounding of all reported values
of Nanomaterials in Suspension by Photon Correlation
havebeenperformedaccordingtotheguidelinesasestablished
Spectroscopy (PCS)
in Practice D6026.
E3025Guide for TieredApproach to Detection and Charac-
1.8 Units—The values stated in SI units are to be regarded terization of Silver Nanomaterials in Textiles
asthestandard.Whereappropriate,c.g.sunitsinadditiontoSI E3080Practice for Regression Analysis with a Single Pre-
units are included in this standard. dictor Variable
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
E3323-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3323 − 21
t
2
3. Terminology
A~t! 5 * ~S!dt (1)
t
1
3.1 Definitions:
Where A(t) and S(t) = Peak area and the instantaneous
3.1.1 accuracy, n—closeness of agreement between a test
detector’s response at time, t, respectively (2).
result and an accepted reference value.
3.1.11 coeffıcient of determination, n—statisticalmeasureof
3.1.1.1 Discussion—The term accuracy, when applied to a
the linear relationship between X and Y calculated by:
set of results, involves a combin
...

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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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4.5 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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Standard Test Method for Measurement of Airborne Metal Oxide Nanoparticle Surface Area Concentration in Inhalation Exposure Chambers using Krypton Gas Adsorption

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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)).  
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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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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.  
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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.  
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.

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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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