Cyclosporin Impurity 16 CAS 79309-68-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.79309-68-5
Molecular FormulaC12H25BO2Si
Molecular Weight240.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cyclosporin Impurity 16 CAS 79309-68-5 chemical structure

Description

Cyclosporin Impurity 16 (CAS 79309-68-5) is a certified pharmaceutical impurity reference standard with the molecular formula C12H25BO2Si and a molecular weight of 240.22 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, Cyclosporin Impurity 16 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 240.22 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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.

Physical & Chemical Properties

Molecular FormulaC12H25BO2Si
Molecular Weight240.22 g/mol
Purity97%+
StorageStore at room temperature
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)0.5
CAS Registry Year (est.)1979

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