Silodosin Impurity N44 CAS 1453221-45-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1453221-45-8
Molecular FormulaC35H41F6N3O6
Molecular Weight713.71 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Silodosin Impurity N44 CAS 1453221-45-8 chemical structure

Description

Silodosin Impurity N44 (CAS 1453221-45-8) is a certified pharmaceutical impurity reference standard with the molecular formula C35H41F6N3O6 and a molecular weight of 713.71 g/mol.

The molecular framework of Silodosin Impurity N44 (C35H41F6N3O6) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine 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. 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.

As a certified reference material (CRM), Silodosin Impurity N44 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 FormulaC35H41F6N3O6
Molecular Weight713.71 g/mol
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1992
Halogen ContentF-containing
Nitrogen Atoms3

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