Leflunomide EP Impurity D CAS 42831-50-5

Description

Compared with other compounds in its class, the molecular weight of 127.10 g/mol gives Leflunomide EP Impurity D distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Leflunomide EP Impurity D (CAS 42831-50-5) is a certified pharmaceutical impurity reference standard with the molecular formula C5H5NO3 and a molecular weight of 127.10 g/mol.

Structurally, Leflunomide EP Impurity D (C5H5NO3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. 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 127.10 g/mol, it falls into the low-molecular-weight range. 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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