Silodosin impurity N1 CAS 1338365-54-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1338365-54-0
Molecular FormulaC22H25N3O2
Molecular Weight363.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Silodosin impurity N1 CAS 1338365-54-0 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 363.45 g/mol gives Silodosin impurity N1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Silodosin impurity N1 (CAS 1338365-54-0) is a certified pharmaceutical impurity reference standard with the molecular formula C22H25N3O2 and a molecular weight of 363.45 g/mol.

Structurally, Silodosin impurity N1 (C22H25N3O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 363.45 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC22H25N3O2
Molecular Weight363.45 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Nitrogen Atoms3

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