Amoxicillin EP impurity D1-1 CAS CATO-C4X-1148115

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1148115
Molecular FormulaC16H21N3O6S
Molecular Weight383.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amoxicillin EP impurity D1-1 CAS CATO-C4X-1148115 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 383.42 g/mol gives Amoxicillin EP impurity D1-1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Amoxicillin EP impurity D1-1 (CAS CATO-C4X-1148115, C16H21N3O6S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Amoxicillin EP impurity D1-1 (C16H21N3O6S) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 383.42 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), Amoxicillin EP impurity D1-1 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

Molecular FormulaC16H21N3O6S
Molecular Weight383.42 g/mol
Purity97%+
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3
Sulfur Atoms1

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