Isepamicin Impurity 8 CAS CATO-C4X-31118

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-31118
Molecular FormulaC19H38N4O10
Molecular Weight482.53 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Isepamicin Impurity 8 CAS CATO-C4X-31118 chemical structure

Description

Isepamicin Impurity 8 (CAS CATO-C4X-31118) is a certified pharmaceutical impurity reference standard with the molecular formula C19H38N4O10 and a molecular weight of 482.53 g/mol.

Based on its molecular formula C19H38N4O10, Isepamicin Impurity 8 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 482.53 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Isepamicin Impurity 8 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 FormulaC19H38N4O10
Molecular Weight482.53 g/mol
AppearanceWhite to pale yellow crystalline powder
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)3.0
UV AbsorptionUV-absorbing
Nitrogen Atoms4

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