Miglustat Impurity 1 CAS CATO-C4X-32031

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-32031
Molecular FormulaC10H21NO3
Molecular Weight203.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Miglustat Impurity 1 CAS CATO-C4X-32031 chemical structure

Description

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Miglustat Impurity 1 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 203.28 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.

Miglustat Impurity 1 (CAS CATO-C4X-32031) is a certified pharmaceutical impurity reference standard with the molecular formula C10H21NO3 and a molecular weight of 203.28 g/mol.

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 FormulaC10H21NO3
Molecular Weight203.28 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
Nitrogen Atoms1

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