Milnacipran Impurity 22 CAS 2254103-64-3

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Milnacipran Impurity 22.

Milnacipran Impurity 22 (CAS 2254103-64-3) is a certified pharmaceutical impurity reference standard with the molecular formula C15H22N2O and a molecular weight of 246.35 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Milnacipran Impurity 22 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 246.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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