Hydantoin Impurity 11 CAS 66618-82-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.66618-82-4
Molecular FormulaC6H11NO2
Molecular Weight129.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Hydantoin Impurity 11 CAS 66618-82-4 chemical structure

Description

CATO supplies Hydantoin Impurity 11 (CAS 66618-82-4), a pharmacopoeial impurity reference standard (molecular formula C6H11NO2, MW 129.16 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Hydantoin Impurity 11 (C6H11NO2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 129.16 g/mol, it falls into the low-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC6H11NO2
Molecular Weight129.16 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1976
Nitrogen Atoms1

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