Cyclophosphamide Impurity 12 CAS CATO-C4X-230612

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-230612
Molecular FormulaC8H20ClN2O4P
Molecular Weight274.68 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cyclophosphamide Impurity 12 CAS CATO-C4X-230612 chemical structure

Description

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 process- or degradation-related impurity, Cyclophosphamide Impurity 12 (CAS CATO-C4X-230612, C8H20ClN2O4P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amide group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Cyclophosphamide Impurity 12 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 274.68 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC8H20ClN2O4P
Molecular Weight274.68 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO
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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