Dexmedetomidine Impurity 57 CAS 617-86-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.617-86-7
Molecular FormulaC6H16Si
Molecular Weight116.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexmedetomidine Impurity 57 CAS 617-86-7 chemical structure

Description

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Dexmedetomidine Impurity 57 (CAS 617-86-7) is a certified pharmaceutical impurity reference standard with the molecular formula C6H16Si and a molecular weight of 116.28 g/mol.

Structurally, Dexmedetomidine Impurity 57 (C6H16Si) contains an organic framework. The molecule exhibits a degree of unsaturation (DBE) of -1.0, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 116.28 g/mol, it falls into the low-molecular-weight range.

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.

Physical & Chemical Properties

Molecular FormulaC6H16Si
Molecular Weight116.28 g/mol
Purity>95%
StorageStore at 2-8°C
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)-1.0
CAS Registry Year (est.)1957

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