Ertapenem Impurity 11 CAS 402955-38-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ertapenem Impurity 11.

As a process- or degradation-related impurity, Ertapenem Impurity 11 (CAS 402955-38-8, C44H50N6O14S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Ertapenem Impurity 11 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 951.03 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Ertapenem Impurity 11 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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