Levetiracetam Impurity 36 CAS 18017-35-1

Description

The occurrence of Levetiracetam Impurity 36 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Levetiracetam Impurity 36 (CAS 18017-35-1) is a certified pharmaceutical impurity reference standard with the molecular formula C4H6Cl2O2 and a molecular weight of 157.00 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Levetiracetam Impurity 36 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 157.00 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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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