N-Nitroso Bupivacaine EP Impurity B CAS 3035512-94-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3035512-94-5
Molecular FormulaC14H19N3O2
Molecular Weight261.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Bupivacaine EP Impurity B CAS 3035512-94-5 chemical structure

Description

The occurrence of N-Nitroso Bupivacaine EP Impurity B is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, N-Nitroso Bupivacaine EP Impurity B (CAS 3035512-94-5, C14H19N3O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

N-Nitroso Bupivacaine EP Impurity B (C14H19N3O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), N-Nitroso Bupivacaine EP Impurity B 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 FormulaC14H19N3O2
Molecular Weight261.32 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
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.)2005
Nitrogen Atoms3

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