Betamethasone Impurity 109 CAS 94135-39-4

Description

The occurrence of Betamethasone Impurity 109 is closely related to a salt form, a flavonoid core, 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.

CATO supplies Betamethasone Impurity 109 (CAS 94135-39-4), a pharmacopoeial impurity reference standard (molecular formula C22H28ClO8PNa, MW 509.87 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Betamethasone Impurity 109 (C22H28ClO8PNa) contains a salt form, a flavonoid core, a phosphate ester group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.5, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 509.87 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Betamethasone Impurity 109 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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