Fluoxetine Impurity 01 CAS 4850-49-1

Description

Compared with other compounds in its class, the molecular weight of 152.19 g/mol gives Fluoxetine Impurity 01 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Fluoxetine Impurity 01 (CAS 4850-49-1) is a certified pharmaceutical impurity reference standard with the molecular formula C9H12O2 and a molecular weight of 152.19 g/mol.

Structurally, Fluoxetine Impurity 01 (C9H12O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 152.19 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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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