Cyclophosphamide EP Impurity D CAS 158401-52-6

Description

The occurrence of Cyclophosphamide EP Impurity D is closely related to an amide group, a phosphonate group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Cyclophosphamide EP Impurity D (CAS 158401-52-6) is a certified pharmaceutical impurity reference standard with the molecular formula C7H16ClN2O3P and a molecular weight of 242.64 g/mol.

Structurally, Cyclophosphamide EP Impurity D (C7H16ClN2O3P) contains an amide group, a phosphonate group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 0.5, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 242.64 g/mol, it falls into the medium-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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