Ropivacaine EP Impurity E(R-Isomer) CAS 1050482-18-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1050482-18-2
Molecular FormulaC17H26N2O
Molecular Weight274.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ropivacaine EP Impurity E(R-Isomer) CAS 1050482-18-2 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.

As a process- or degradation-related impurity, Ropivacaine EP Impurity E(R-Isomer) (CAS 1050482-18-2, C17H26N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ropivacaine EP Impurity E(R-Isomer) (C17H26N2O) contains a steroid core, 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).

As a certified reference material (CRM), Ropivacaine EP Impurity E(R-Isomer) 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 FormulaC17H26N2O
Molecular Weight274.40 g/mol
Purity97%+
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.)1988
Nitrogen Atoms2

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