Famotidine EP Impurity B CAS 89268-62-2

Purity >80%In StockPharmacopoeial Impurity Standards
CAS No.89268-62-2
Molecular FormulaC16H23N11O2S5
Molecular Weight561.75 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Famotidine EP Impurity B CAS 89268-62-2 chemical structure

Description

The molecular framework of Famotidine EP Impurity B (C16H23N11O2S5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. 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).

Famotidine EP Impurity B (CAS 89268-62-2) is a certified pharmaceutical impurity reference standard with the molecular formula C16H23N11O2S5 and a molecular weight of 561.75 g/mol.

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 FormulaC16H23N11O2S5
Molecular Weight561.75 g/mol
Purity>80%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1982
Nitrogen Atoms11
Sulfur Atoms5

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