Hydantoin Impurity 12 CAS 113586-23-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.113586-23-5
Molecular FormulaC6H11NO2
Molecular Weight129.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Hydantoin Impurity 12 CAS 113586-23-5 chemical structure

Description

The occurrence of Hydantoin Impurity 12 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Hydantoin Impurity 12 (CAS 113586-23-5), a pharmacopoeial impurity reference standard (molecular formula C6H11NO2, MW 129.16 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Hydantoin Impurity 12 (C6H11NO2) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Hydantoin Impurity 12 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 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.)1989
Nitrogen Atoms1

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