Clofarabine Impurity 12 CAS 5451-40-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.5451-40-1
Molecular FormulaC5H2Cl2N4
Molecular Weight189.00 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clofarabine Impurity 12 CAS 5451-40-1 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 Clofarabine Impurity 12.

CATO supplies Clofarabine Impurity 12 (CAS 5451-40-1), a pharmacopoeial impurity reference standard (molecular formula C5H2Cl2N4, MW 189.00 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Clofarabine Impurity 12 (C5H2Cl2N4) is characterized by a nitrile group, 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC5H2Cl2N4
Molecular Weight189.00 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1958
Halogen ContentCl-containing
Nitrogen Atoms4

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