Roxithromycin EP Impurity K CAS CATO-C4X-130312

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-130312
Molecular FormulaC41H76N2O16
Molecular Weight853.05 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxithromycin EP Impurity K CAS CATO-C4X-130312 chemical structure

Description

CATO supplies Roxithromycin EP Impurity K (CAS CATO-C4X-130312), a pharmacopoeial impurity reference standard (molecular formula C41H76N2O16, MW 853.05 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Roxithromycin EP Impurity K (C41H76N2O16) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 853.05 g/mol, it falls into the high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

CATO manufactures Roxithromycin EP Impurity K under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC41H76N2O16
Molecular Weight853.05 g/mol
Purity>90%
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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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