Spiramycin EP Impurity H CAS CATO-C4X-23257

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-23257
Molecular FormulaC40H68N2O12
Molecular Weight768.48 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Spiramycin EP Impurity H CAS CATO-C4X-23257 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Spiramycin EP Impurity H.

Spiramycin EP Impurity H (CAS CATO-C4X-23257) is a certified pharmaceutical impurity reference standard with the molecular formula C40H68N2O12 and a molecular weight of 768.48 g/mol.

Based on its molecular formula C40H68N2O12, Spiramycin EP Impurity H contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 768.48 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

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 Spiramycin EP Impurity H 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 FormulaC40H68N2O12
Molecular Weight768.48 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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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