N-Nitroso Bromhexine impurity 58 CAS CATO-C4X-106058

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106058
Molecular FormulaC4H4N2O3
Molecular Weight128.09 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Bromhexine impurity 58 CAS CATO-C4X-106058 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including N-Nitroso Bromhexine impurity 58.

As a process- or degradation-related impurity, N-Nitroso Bromhexine impurity 58 (CAS CATO-C4X-106058, C4H4N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of N-Nitroso Bromhexine impurity 58 (C4H4N2O3) 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), N-Nitroso Bromhexine impurity 58 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 FormulaC4H4N2O3
Molecular Weight128.09 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Nitrogen Atoms2

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