Spiramycin EP Impurity D CAS CATO-C4X-23254

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-23254
Molecular FormulaC43H73NO16
Molecular Weight859.49 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Spiramycin EP Impurity D CAS CATO-C4X-23254 chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Spiramycin EP Impurity D is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 859.49 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).

CATO supplies Spiramycin EP Impurity D (CAS CATO-C4X-23254), a pharmacopoeial impurity reference standard (molecular formula C43H73NO16, MW 859.49 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 D 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 FormulaC43H73NO16
Molecular Weight859.49 g/mol
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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