Valsartan Impurity 120 CAS 137863-48-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.137863-48-0
Molecular FormulaC25H31N5O3
Molecular Weight449.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Valsartan Impurity 120 CAS 137863-48-0 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.

As a process- or degradation-related impurity, Valsartan Impurity 120 (CAS 137863-48-0, C25H31N5O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Valsartan Impurity 120 (C25H31N5O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 449.55 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.

Physical & Chemical Properties

Molecular FormulaC25H31N5O3
Molecular Weight449.55 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1996
Nitrogen Atoms5

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