Cyclophosphamide Impurity 22 CAS 3308-51-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3308-51-8
Molecular FormulaC7H17Cl2N2O3P
Molecular Weight279.10 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cyclophosphamide Impurity 22 CAS 3308-51-8 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Cyclophosphamide Impurity 22.

As a process- or degradation-related impurity, Cyclophosphamide Impurity 22 (CAS 3308-51-8, C7H17Cl2N2O3P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Cyclophosphamide Impurity 22 (C7H17Cl2N2O3P) 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. 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.

As a certified reference material (CRM), Cyclophosphamide Impurity 22 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC7H17Cl2N2O3P
Molecular Weight279.10 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.)1957
Halogen ContentCl-containing
Nitrogen Atoms2

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