Dihydrocodeine impurity 1 CAS 23185-97-9

Description

The occurrence of Dihydrocodeine impurity 1 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Dihydrocodeine impurity 1 (CAS 23185-97-9) is a certified pharmaceutical impurity reference standard with the molecular formula C18H21NO5 and a molecular weight of 331.36 g/mol.

Based on its molecular formula C18H21NO5, Dihydrocodeine impurity 1 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 331.36 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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