| Trehalose EP Impurity B is chemically Oligosaccharides, mainly glucosyltrehalose: mixture of alpha-D-glucopyranosyl alpha-D-glucopyranosyl-(1→4)-alpha-D-glucopyranoside (4-O-glucosyltrehalose or alpha-D-maltosyl alpha-D-glucoside) and alpha-D-glucopyranosyl-(1→6)-alpha-D-glucopyranosyl alpha-D-glucopyranoside (6-O-glucosyltrehalose or alpha-D-isomaltosyl alpha-D-glucoside). (as per EP). Trehalose EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Trehalose EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Trehalose. The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ChemWhat products are for analytical purpose only and not for human use. |