Pivmecillinam Impurity 13 CAS CATO-C4X-232313

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-232313
Molecular FormulaC15H24N2O7S
Molecular Weight376.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pivmecillinam Impurity 13 CAS CATO-C4X-232313 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pivmecillinam Impurity 13.

As a process- or degradation-related impurity, Pivmecillinam Impurity 13 (CAS CATO-C4X-232313, C15H24N2O7S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pivmecillinam Impurity 13 (C15H24N2O7S) contains a nitrogen-containing heterocyclic scaffold, 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

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 FormulaC15H24N2O7S
Molecular Weight376.43 g/mol
Purity≥95%
StorageStore at 2-8°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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2
Sulfur Atoms1

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