Bupivacaine Impurity 44 CAS 104485-01-0

Purity 95In StockPharmacopoeial Impurity Standards
CAS No.104485-01-0
Molecular FormulaC22H34N2O3
Molecular Weight374.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bupivacaine Impurity 44 CAS 104485-01-0 chemical structure

Description

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.

CATO supplies Bupivacaine Impurity 44 (CAS 104485-01-0), a pharmacopoeial impurity reference standard (molecular formula C22H34N2O3, MW 374.52 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Bupivacaine Impurity 44 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 374.52 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

CATO manufactures Bupivacaine Impurity 44 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.

Physical & Chemical Properties

Molecular FormulaC22H34N2O3
Molecular Weight374.52 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity95
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Nitrogen Atoms2

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