Gabapentin Impurity 16 CAS 1281568-83-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1281568-83-9
Molecular FormulaC13H23NO3
Molecular Weight241.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gabapentin Impurity 16 CAS 1281568-83-9 chemical structure

Description

CATO manufactures Gabapentin Impurity 16 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 16 (CAS 1281568-83-9), a pharmacopoeial impurity reference standard (molecular formula C13H23NO3, MW 241.33 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Gabapentin Impurity 16 (C13H23NO3) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 241.33 g/mol, it falls into the medium-molecular-weight range. 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 FormulaC13H23NO3
Molecular Weight241.33 g/mol
AppearanceWhite to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1990
Nitrogen Atoms1

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