Bupivacaine EP Impurity B CAS 15883-20-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.15883-20-2
Molecular FormulaC14H20N2O
Molecular Weight232.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bupivacaine EP Impurity B CAS 15883-20-2 chemical structure

Description

CATO manufactures Bupivacaine EP Impurity B 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.

As a process- or degradation-related impurity, Bupivacaine EP Impurity B (CAS 15883-20-2, C14H20N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Bupivacaine EP Impurity B (C14H20N2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; 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.

Physical & Chemical Properties

Molecular FormulaC14H20N2O
Molecular Weight232.32 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Nitrogen Atoms2

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