Bupivacaine Impurity 32 CAS 2199805-25-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2199805-25-7
Molecular FormulaC13H19NO2
Molecular Weight221.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bupivacaine Impurity 32 CAS 2199805-25-7 chemical structure

Description

As a certified reference material (CRM), Bupivacaine Impurity 32 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.

Bupivacaine Impurity 32 (CAS 2199805-25-7) is a certified pharmaceutical impurity reference standard with the molecular formula C13H19NO2 and a molecular weight of 221.30 g/mol.

The molecular framework of Bupivacaine Impurity 32 (C13H19NO2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

Physical & Chemical Properties

Molecular FormulaC13H19NO2
Molecular Weight221.30 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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
CAS Registry Year (est.)1998
Nitrogen Atoms1

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