Gabapentin EP Impurity A CAS 64744-50-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.64744-50-9
Molecular FormulaC9H15NO
Molecular Weight153.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gabapentin EP Impurity A CAS 64744-50-9 chemical structure

Description

The occurrence of Gabapentin EP Impurity A is closely related to an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Gabapentin EP Impurity A (CAS 64744-50-9), a pharmacopoeial impurity reference standard (molecular formula C9H15NO, MW 153.22 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Gabapentin EP Impurity A (C9H15NO) contains an amide 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 153.22 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.

As a certified reference material (CRM), Gabapentin EP Impurity A meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC9H15NO
Molecular Weight153.22 g/mol
AppearanceWhite to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1975
Nitrogen Atoms1

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