Spiramycin EP Impurity B CAS CATO-C4X-23252

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-23252
Molecular FormulaC45H80N2O14
Molecular Weight872.56 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Spiramycin EP Impurity B CAS CATO-C4X-23252 chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Spiramycin EP Impurity B is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 872.56 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

CATO supplies Spiramycin EP Impurity B (CAS CATO-C4X-23252), a pharmacopoeial impurity reference standard (molecular formula C45H80N2O14, MW 872.56 g/mol) used for the identification and quantification of trace impurities in APIs.

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), Spiramycin EP Impurity B 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 FormulaC45H80N2O14
Molecular Weight872.56 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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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