Cholecalciferol EP Impurity B CAS 434-16-2

Description

The occurrence of Cholecalciferol EP Impurity B is closely related to a steroid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Cholecalciferol EP Impurity B (CAS 434-16-2) is a certified pharmaceutical impurity reference standard with the molecular formula C27H44O and a molecular weight of 384.64 g/mol.

Owing to a steroid core, a hydroxyl group, an ether linkage, Cholecalciferol EP Impurity B is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 384.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Cholecalciferol EP Impurity B 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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