Estriol EP Impurity H CAS 566-76-7

Description

The occurrence of Estriol EP Impurity H 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.

Estriol EP Impurity H (CAS 566-76-7) is a certified pharmaceutical impurity reference standard with the molecular formula C18H22O3 and a molecular weight of 286.37 g/mol.

Structurally, Estriol EP Impurity H (C18H22O3) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 286.37 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Estriol EP Impurity H 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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