Relebactam Impurity 10 CAS CATO-C4X-214410

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-214410
Molecular FormulaC18H28N4O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Relebactam Impurity 10 CAS CATO-C4X-214410 chemical structure

Description

CATO supplies Relebactam Impurity 10 (CAS CATO-C4X-214410), a pharmacopoeial impurity reference standard (molecular formula C18H28N4O2HCl, MW 368.91 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H28N4O2HCl, Relebactam Impurity 10 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 368.91 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Relebactam Impurity 10 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 FormulaC18H28N4O2 HCl
Molecular Weight368.91 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity95%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms4

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