| Gabapentine Impurity 40 is chemically (8’S,9’R,10’S,10a’S)-8′,9′-dihydroxy-10a’-(hydroxymethyl)-10′-(((2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-5’H,7’H-spiro[cyclohexane-1,4′-pyrido[2,1-b][1,3]oxazepin]-2′(3’H)-one. Gabapentine Impurity 40 is supplied with detailed characterization data compliant with regulatory guideline. Gabapentine Impurity 40 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 Gabapentin. The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ChemWhat products are for analytical purpose only and not for human use. |