Cyclophosphamide impurity 01 CAS 35144-64-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.35144-64-0
Molecular FormulaC7H15Cl2N2O3P
Molecular Weight277.09 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cyclophosphamide impurity 01 CAS 35144-64-0 chemical structure

Description

The molecular framework of Cyclophosphamide impurity 01 (C7H15Cl2N2O3P) is characterized by an amide group, a phosphonate 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

As a process- or degradation-related impurity, Cyclophosphamide impurity 01 (CAS 35144-64-0, C7H15Cl2N2O3P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC7H15Cl2N2O3P
Molecular Weight277.09 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, water
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
CAS Registry Year (est.)1967
Halogen ContentCl-containing
Nitrogen Atoms2

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