Difelikefalin Impurity 66 CAS CATO-C4X-304166

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-304166
Molecular FormulaC34H48N4O8
Molecular Weight640.77 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Difelikefalin Impurity 66 CAS CATO-C4X-304166 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 Difelikefalin Impurity 66.

Difelikefalin Impurity 66 (CAS CATO-C4X-304166) is a certified pharmaceutical impurity reference standard with the molecular formula C34H48N4O8 and a molecular weight of 640.77 g/mol.

Based on its molecular formula C34H48N4O8, Difelikefalin Impurity 66 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 640.77 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.

As a certified reference material (CRM), Difelikefalin Impurity 66 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 FormulaC34H48N4O8
Molecular Weight640.77 g/mol
Purity95%
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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

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