Cyclophosphamide EP Impurity C HCl CAS 821-48-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.821-48-7
Molecular FormulaC4H9Cl2N
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cyclophosphamide EP Impurity C HCl CAS 821-48-7 chemical structure

Description

As a process- or degradation-related impurity, Cyclophosphamide EP Impurity C HCl (CAS 821-48-7, C4H9Cl2NHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to chlorine substitution, Cyclophosphamide EP Impurity C HCl is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 178.48 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC4H9Cl2N HCl
Molecular Weight178.48 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-1.0
CAS Registry Year (est.)1957
Halogen ContentCl-containing
Nitrogen Atoms1

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