Detection and Quantification of β-(1,3)-D-Glucan Contamination  in Nanoparticle Formulations by Factor C Depleted LAL (Glucatell®) Assay

Detection and Quantification of β-(1,3)-D-Glucan Contamination in Nanoparticle Formulations by Factor C Depleted LAL (Glucatell®) Assay

Standard Number STE-4
Organization Nanotechnology Characterization Laboratory USA
Level National
Category Test Method | Characterization | Measurement
Status
  • JUL 2020 Published
ABSTRACT
This document describes a protocol for the quantitative detection of β-(1,3)-D-glucans in nanoparticle preparations using a chromogenic endpoint Glucatell assay. β-(1,3)-D-glucans are products of cell walls of some microorganisms, including yeast and fungi. The most common source of β-(1,3)-D-glucans is fungi Candida and Aspergillus.