Compliance of GPC Method with Proposed USP Monograph

This technical report details the compliance of a Gel Permeation Chromatography (GPC) method with the requirements outlined in a proposed United States Pharmacopeia (USP) monograph for sorbitan sesquioleate. The report describes the implementation of the GPC method using an Arc HPLC System equipped with a refractive index detector, focusing on the assay procedure and the limit test for organic impurities. The proposed updates to the USP monograph aim to modernize the assay procedure for sorbitan sesquioleate, replacing previous tests with a GPC method. The results of the GPC analysis demonstrated that all system suitability specifications and acceptance criteria were met for both the assay and organic impurities testing, confirming compliance with the proposed USP requirements. The report includes detailed descriptions of the experimental conditions, materials used, and the results of the analysis, ensuring that the methodology aligns with the latest standards set forth by the USP.