Pregabalin EP Impurity B

Pregabalin EP Impurity B is chemically (R)-3-(aminomethyl)-5-methylhexanoic acid ; (3R)-3-(aminomethyl)-5-methylhexanoic acid (pregabalin enantiomer) ; (R)-Pregabalin. It is also known as Pregabalin USP Related Compound A. Pregabalin EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Pregabalin 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 Pregabalin.

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.