Clavulanate Potassium EP Impurity M DiHCl CAS 103526-47-2

Description

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

Clavulanate Potassium EP Impurity M DiHCl (CAS 103526-47-2) is a certified pharmaceutical impurity reference standard with the molecular formula C8H20N2OHCl and a molecular weight of 196.72 g/mol.

Based on its molecular formula C8H20N2OHCl, Clavulanate Potassium EP Impurity M DiHCl contains an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 196.72 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), Clavulanate Potassium EP Impurity M DiHCl 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

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