Tolperisone Impurity 5 CAS 756433-31-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.756433-31-5
Molecular FormulaC16H23NO
Molecular Weight245.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tolperisone Impurity 5 CAS 756433-31-5 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, Tolperisone Impurity 5 (CAS 756433-31-5, C16H23NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Tolperisone Impurity 5 (C16H23NO) 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).

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC16H23NO
Molecular Weight245.36 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Nitrogen Atoms1

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