1. Scope

Keywords

Rationale

Poly(ethylene glycol) (PEG) and their derivatives are utilized in many drug products, devices, cosmetics, and consumer products. PEG derivatives and bifunctional PEGs with various molecular weights have been utilized for surface functionalization and bioconjugations with nanomaterials to provide aqueous solubility, long-term colloidal stability, and biocompatibility. The differences in the quantity of nanomaterial surface-bound PEG in drug products containing nanomaterials may lead to an altered biocompatibility, immune system recognition, biodistribution, safety and efficacy. Hence, the quantitative measurement of PEG (i.e., either bound or unbound to the nanomaterial surface) is a critical quality attribute for drug products containing PEGylated nanomaterials and requires standardized methods and methodologies. This test method describes a standardized assay for the quantitative assessment of PEG coating on a gold nanoparticle (AuNP) using a high-performance liquid chromatography (HPLC) system with a mass-flow sensitive evaporative light-scattering detector. This test method is critical to the drug development, quality control, and assurance of nanoparticle containing products for pharmaceutical industry and the review of such products by regulatory agencies.