Clindamycin Phosphate EP Impurity K CAS CATO-C4X-134137

Description

The occurrence of Clindamycin Phosphate EP Impurity K is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a phosphate ester group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Clindamycin Phosphate EP Impurity K (CAS CATO-C4X-134137) is a certified pharmaceutical impurity reference standard with the molecular formula C36H66Cl2N4O15P2S2 and a molecular weight of 991.91 g/mol.

Structurally, Clindamycin Phosphate EP Impurity K (C36H66Cl2N4O15P2S2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a phosphate ester group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 991.91 g/mol, it falls into the high-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.

As a certified reference material (CRM), Clindamycin Phosphate EP Impurity K 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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