Work Item
ASTM WK86057

New Test Method for New Standard Test Method for Measuring Sulfate and Ammonium Ion Concentrations in Liposome Drug Formulations

1. Scope

Standard test method for determination of ammonium and sulfate ions in liposomal-doxorubicin formulation in three different cases: 1) total amount of ammonium and sulfate, 2) amount of ammonium and sulfate inside liposome, and 3) amount of ammonium and sulfate outside liposome.

Keywords

entrapped ions; ion chromatography; separating entrapped and free ions

Rationale

Doxorubicin is actively loaded into liposomes by using transmembrane ammonium sulfate gradient. Ammonium and sulfate ion are important in determining stability of the doxorubicin liposomal formulation therefore a robust and standardized analytical method for determining their concentration is useful for drug manufacturers, clinicians as well as academic researchers.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E56.08

Committee: E56

Staff Manager: Frank McConnell

Work Item Status

Date Initiated: 04-21-2023

Technical Contact: Arjun Sharmah

Item: 000

Ballot:

Status: