Fludarabine Phosphate Impurity 13 CAS 71261-44-4

Description

Compared with other compounds in its class, the molecular weight of 365.21 g/mol gives Fludarabine Phosphate Impurity 13 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Fludarabine Phosphate Impurity 13 (CAS 71261-44-4, C10H13FN5O7P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Fludarabine Phosphate Impurity 13 (C10H13FN5O7P) contains a nitrogen-containing heterocyclic scaffold, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.5, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 365.21 g/mol, it falls into the moderately-high-molecular-weight range. 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.

As a certified reference material (CRM), Fludarabine Phosphate Impurity 13 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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