| CAS No. | CATO-C4X-230628 |
| Molecular Formula | C13H30ClN2O9P |
| Molecular Weight | 424.81 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
| Molecular Formula | C13H30ClN2O9P |
| Molecular Weight | 424.81 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-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 Content | Cl-containing |
| Nitrogen Atoms | 2 |