Pregabalin Impurity 53 is chemically 2-(1-Amino-4-methylpentan-2-yl)malonic acid. Pregabalin Impurity 53 is supplied with detailed characterization data compliant with regulatory guideline. Pregabalin Impurity 53 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.