Cyclophosphamide impurity 28 CAS CATO-C4X-230628

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-230628
Molecular FormulaC13H30ClN2O9P
Molecular Weight424.81 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cyclophosphamide impurity 28 CAS CATO-C4X-230628 chemical structure

Description

CATO supplies Cyclophosphamide impurity 28 (CAS CATO-C4X-230628), a pharmacopoeial impurity reference standard (molecular formula C13H30ClN2O9P, MW 424.81 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Cyclophosphamide impurity 28 (C13H30ClN2O9P) is characterized by an amide group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. 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.

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 FormulaC13H30ClN2O9P
Molecular Weight424.81 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)-0.5
Halogen ContentCl-containing
Nitrogen Atoms2

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