Fusidic Acid EP Impurity B

Fusidic Acid EP Impurity B is chemically Ent-(17Z)-3β,11β-dihydroxy-17-[(6SR)-6-hydroxy-7,7-dimethyl-2-oxooxepan-3-ylidene]-4β,8,14-trimethyl-18-nor-5β,10α-androstan-16α-yl acetate (as per EP). It is also known as 24,25-Dihydro-24,25-dihydroxyfusidic acid 21,25-lactone (EP). Fusidic Acid EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Fusidic Acid 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 Pharmaceutical Reference Standards.

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