Pivmecillinam Impurity 11 CAS CATO-C4X-232311

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-232311
Molecular FormulaC21H35N3O6S
Molecular Weight457.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pivmecillinam Impurity 11 CAS CATO-C4X-232311 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.

CATO supplies Pivmecillinam Impurity 11 (CAS CATO-C4X-232311), a pharmacopoeial impurity reference standard (molecular formula C21H35N3O6S, MW 457.58 g/mol) used for the identification and quantification of trace impurities in APIs.

Pivmecillinam Impurity 11 (C21H35N3O6S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; 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 FormulaC21H35N3O6S
Molecular Weight457.58 g/mol
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
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 Atoms3
Sulfur Atoms1

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