Neomycin sulfate EP Impurity B

Determination of neomycin sulfate and impurities using high-performance anion-exchange chromatography with integrated pulsed amperometric detection
Valoran P. Hanko ∗, Jeffrey S. Rohrer
Journal of Pharmaceutical and Biomedical Analysis 43 (2007) 131–141

Neomycin sulfate EP Impurity B is chemically N-((1S,2R,3R,4S,5R)-5-amino-2-(((2R,3R,4R,5S,6R)-3-amino-6-(aminomethyl)-4,5-dihydroxytetrahydro-2H-pyran-2-yl)oxy)-3,4-dihydroxycyclohexyl)acetamide. It is also known as 3-Acetylneamine. Neomycin sulfate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Neomycin sulfate 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 Neomycin sulfate.

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.