Levocarnitine Impurity 11 CAS 835638-57-8

Description

The occurrence of Levocarnitine Impurity 11 is closely related to an amide group, 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.

CATO supplies Levocarnitine Impurity 11 (CAS 835638-57-8), a pharmacopoeial impurity reference standard (molecular formula C7H14NO2Cl, MW 179.64 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Levocarnitine Impurity 11 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 179.64 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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