Racecadotril Impurity 15 CAS 80-48-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.80-48-8
Molecular FormulaC8H10O3S
Molecular Weight186.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Racecadotril Impurity 15 CAS 80-48-8 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.

Racecadotril Impurity 15 (CAS 80-48-8) is a certified pharmaceutical impurity reference standard with the molecular formula C8H10O3S and a molecular weight of 186.23 g/mol.

Owing to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Racecadotril Impurity 15 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 186.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 FormulaC8H10O3S
Molecular Weight186.23 g/mol
Purity>95%
StorageStore at 2-8°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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Sulfur Atoms1

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