ASTM-E3323 2022

$37.38

E3323-22 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)

Published By	Publication Date	Number of Pages
ASTM	2022	20

Guaranteed Safe Checkout

Category: ASTM

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

ASTM E3323-22

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

ASTM E3323

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.

Keywords

cholesterol; DSPE-PEG 2000; ELSD; HPLC; HSPC; liposomal formulation; lipid quantitaion;

ICS Code

ICS Number Code 07.120 (Nanotechnologies)

DOI: 10.1520/E3323-22

Additional information

Standard Title	E3323-22 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)
Published Code	ASTM
Publication Date	2022
Pages Count	20