Promethazine EP Impurity D CAS 7640-51-9

Description

Compared with other compounds in its class, the molecular weight of 300.42 g/mol gives Promethazine EP Impurity D distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Promethazine EP Impurity D (CAS 7640-51-9) is a certified pharmaceutical impurity reference standard with the molecular formula C17H20N2OS and a molecular weight of 300.42 g/mol.

Structurally, Promethazine EP Impurity D (C17H20N2OS) contains a steroid core, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 300.42 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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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