Trehalose EP Impurity B

Trehalose EP Impurity B is chemically Oligosaccharides, mainly glucosyltrehalose: mixture of α-D-glucopyranosyl α-D-glucopyranosyl-(1→4)-α-D-glucopyranoside (4-O-glucosyltrehalose or α-D-maltosyl α-D-glucoside) and α-D-glucopyranosyl-(1→6)-α-D-glucopyranosyl α-D-glucopyranoside (6-O-glucosyltrehalose or α-D-isomaltosyl α-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 EP Impurity B.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. K.M.Pharma products are for analytical purpose only and not for human use.