Gabapentin impurity 30 CAS CATO-C4X-165430

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-165430
Molecular Formula2*C21H35NO11
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gabapentin impurity 30 CAS CATO-C4X-165430 chemical structure

Description

As a process- or degradation-related impurity, Gabapentin impurity 30 (CAS CATO-C4X-165430, C21H35NO11) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Gabapentin impurity 30 (C21H35NO11) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 impurity 30 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 Formula2*C21H35NO11
Molecular Weight477.51 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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