Sivelestat sodium impurity 31 CAS CATO-C4X-212331

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-212331
Molecular FormulaC11H13O5S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sivelestat sodium impurity 31 CAS CATO-C4X-212331 chemical structure

Description

As a certified reference material (CRM), Sivelestat sodium impurity 31 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.

Sivelestat sodium impurity 31 (CAS CATO-C4X-212331) is a certified pharmaceutical impurity reference standard with the molecular formula C11H13O5SNa and a molecular weight of 280.27 g/mol.

Structurally, Sivelestat sodium impurity 31 (C11H13O5SNa) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 5.5, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 280.27 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC11H13O5S Na
Molecular Weight280.27 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Sulfur Atoms1

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