Racecadotril Impurity 17 CAS CATO-C4X-110617

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-110617
Molecular FormulaC11H13NO3
Molecular Weight207.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Racecadotril Impurity 17 CAS CATO-C4X-110617 chemical structure

Description

Racecadotril Impurity 17 (CAS CATO-C4X-110617) is a certified pharmaceutical impurity reference standard with the molecular formula C11H13NO3 and a molecular weight of 207.23 g/mol.

The molecular framework of Racecadotril Impurity 17 (C11H13NO3) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 certified reference material (CRM), Racecadotril Impurity 17 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 FormulaC11H13NO3
Molecular Weight207.23 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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