Lysine Impurity 7 (Ac-DL-Lys(Ac)-OH) CAS 35436-74-9

Description

The occurrence of Lysine Impurity 7 (Ac-DL-Lys(Ac)-OH) is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Lysine Impurity 7 (Ac-DL-Lys(Ac)-OH) (CAS 35436-74-9) is a certified pharmaceutical impurity reference standard with the molecular formula C10H18N2O4 and a molecular weight of 230.26 g/mol.

The molecular framework of Lysine Impurity 7 (Ac-DL-Lys(Ac)-OH) (C10H18N2O4) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

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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