Gabapentin Impurity 8 HCl CAS 1083246-63-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1083246-63-2
Molecular FormulaC18H32N2O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gabapentin Impurity 8 HCl CAS 1083246-63-2 chemical structure

Description

CATO manufactures Gabapentin Impurity 8 HCl under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

CATO supplies Gabapentin Impurity 8 HCl (CAS 1083246-63-2), a pharmacopoeial impurity reference standard (molecular formula C18H32N2O3HCl, MW 360.92 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Gabapentin Impurity 8 HCl is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 360.92 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

Physical & Chemical Properties

Molecular FormulaC18H32N2O3 HCl
Molecular Weight360.92 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1989
Halogen ContentCl-containing
Nitrogen Atoms2

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