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Pregabalin Impurity 16 is chemically (S)-1-(((2R,3S,4S,5R)-2,3-dihydroxy-5-(hydroxymethyl)-4-(((2R,3R,4S,5R,6S)-3,4,5,6-tetrahydroxytetrahydro-2H-pyran-2-yl)oxy)tetrahydrofuran-2-yl)methyl)-4-isobutylpyrrolidin-2-one compound with (S)-4-isobutyl-1-(((2R,3S,4R,5R)-2,3,5-trihydroxy-4-(((2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2-yl)methyl)pyrrolidin-2-one (1:1).
Pregabalin Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Pregabalin Impurity 16 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. ISP Standards products are for analytical purpose only and not for human use.