Meropenem Impurity 54 CAS CATO-C4X-130954

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-130954
Molecular FormulaC51H75N9O15S3
Molecular Weight1150.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Meropenem Impurity 54 CAS CATO-C4X-130954 chemical structure

Description

As a process- or degradation-related impurity, Meropenem Impurity 54 (CAS CATO-C4X-130954, C51H75N9O15S3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Meropenem Impurity 54 (C51H75N9O15S3) 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. 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).

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 FormulaC51H75N9O15S3
Molecular Weight1150.39 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)19.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms9
Sulfur Atoms3

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