Dexmedetomidine Impurity 94 CAS CATO-C4X-123094

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-123094
Molecular FormulaC16H24N2Si
Molecular Weight272.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexmedetomidine Impurity 94 CAS CATO-C4X-123094 chemical structure

Description

The occurrence of Dexmedetomidine Impurity 94 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Dexmedetomidine Impurity 94 (CAS CATO-C4X-123094, C16H24N2Si) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Dexmedetomidine Impurity 94 (C16H24N2Si) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), Dexmedetomidine Impurity 94 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

Molecular FormulaC16H24N2Si
Molecular Weight272.46 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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