Nizatidine EP Impurity A CAS 54252-45-8

Description

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

CATO supplies Nizatidine EP Impurity A (CAS 54252-45-8), a pharmacopoeial impurity reference standard (molecular formula C4H9N3O2, MW 131.13 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C4H9N3O2, Nizatidine EP Impurity A contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 131.13 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), Nizatidine EP Impurity A 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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