ASTM E3297-21
Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)

Standard No.

ASTM E3297-21

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E3297-21

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-3phosphoethanolamine-N-[methoxy(polyethylene glycol)2000] (DSPE-PEG 2000) and hydrogenated soy L-αphosphatidylcholine (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.

ASTM E3297-21 Referenced Document

• ASTM D1193 Standard Specification for Reagent Water
• ASTM D1356 Standard Terminology Relating to Sampling and Analysis of Atmospheres*， 2024-04-22 Update
• ASTM D6026 Standard Practice for Using Significant Digits in Geotechnical Data
• ASTM D7439 Standard Test Method for Determination of Elements in Airborne Particulate Matter by Inductively Coupled Plasma–Mass Spectrometry
• ASTM E131 Standard Definitions of Terms and Symbols Relating to Molecular Spectroscopy
• ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• ASTM E2490 Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
• ASTM E3025 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles*， 2022-11-15 Update
• ASTM E3080 Standard Practice for Regression Analysis with a Single Predictor Variable*， 2023-11-01 Update
• ASTM E456 Standard Terminology for Relating to Quality and Statistics
• ASTM E682 Standard Practice for Liquid Chromatography Terms and Relationships

ASTM E3297-21 history

• 2021 ASTM E3297-21 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)