Capecitabine Impurity 35 CAS 1801-06-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1801-06-5
Molecular FormulaC5H4ClFN2O
Molecular Weight162.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Capecitabine Impurity 35 CAS 1801-06-5 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 Capecitabine Impurity 35.

CATO supplies Capecitabine Impurity 35 (CAS 1801-06-5), a pharmacopoeial impurity reference standard (molecular formula C5H4ClFN2O, MW 162.55 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Capecitabine Impurity 35 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 162.55 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 FormulaC5H4ClFN2O
Molecular Weight162.55 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity97%+
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)4.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1957
Halogen ContentF/Cl-containing
Nitrogen Atoms2

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