Isosorbide Dinitrate Impurity 18 (Diluted with Lactose) CAS 16908-90-0

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Isosorbide Dinitrate Impurity 18 (Diluted with Lactose).

Isosorbide Dinitrate Impurity 18 (Diluted with Lactose) (CAS 16908-90-0) is a certified pharmaceutical impurity reference standard with the molecular formula C6H9NO6 and a molecular weight of 191.14 g/mol.

Structurally, Isosorbide Dinitrate Impurity 18 (Diluted with Lactose) (C6H9NO6) contains a carbohydrate-derived structure, an amide group. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 191.14 g/mol, it falls into the medium-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), Isosorbide Dinitrate Impurity 18 (Diluted with Lactose) 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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