Bepotastine Impurity 11 CAS 1039957-36-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1039957-36-2
Molecular FormulaC9H17NO3
Molecular Weight187.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bepotastine Impurity 11 CAS 1039957-36-2 chemical structure

Description

As a certified reference material (CRM), Bepotastine Impurity 11 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.

CATO supplies Bepotastine Impurity 11 (CAS 1039957-36-2), a pharmacopoeial impurity reference standard (molecular formula C9H17NO3, MW 187.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Bepotastine Impurity 11 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 187.24 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 FormulaC9H17NO3
Molecular Weight187.24 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1988
Nitrogen Atoms1

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