Ertapenem Impurity 53 CAS CATO-C4X-163353

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-163353
Molecular FormulaC29H29N2O11P
Molecular Weight612.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ertapenem Impurity 53 CAS CATO-C4X-163353 chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, Ertapenem Impurity 53 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 612.52 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a process- or degradation-related impurity, Ertapenem Impurity 53 (CAS CATO-C4X-163353, C29H29N2O11P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaC29H29N2O11P
Molecular Weight612.52 g/mol
Purity97%+
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)16.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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