Ibrutinib Impurity 55 CAS 5399-92-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.5399-92-8
Molecular FormulaC5H3ClN4
Molecular Weight154.56 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 55 CAS 5399-92-8 chemical structure

Description

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.

Ibrutinib Impurity 55 (CAS 5399-92-8) is a certified pharmaceutical impurity reference standard with the molecular formula C5H3ClN4 and a molecular weight of 154.56 g/mol.

Owing to a nitrile group, chlorine substitution, Ibrutinib Impurity 55 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 154.56 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.

Physical & Chemical Properties

Molecular FormulaC5H3ClN4
Molecular Weight154.56 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
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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