Sacubitril Impurity 20 CAS 2459446-51-4

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.2459446-51-4
Molecular FormulaC25H31NO5
Molecular Weight425.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sacubitril Impurity 20 CAS 2459446-51-4 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.

Sacubitril Impurity 20 (CAS 2459446-51-4) is a certified pharmaceutical impurity reference standard with the molecular formula C25H31NO5 and a molecular weight of 425.52 g/mol.

The molecular framework of Sacubitril Impurity 20 (C25H31NO5) is characterized by a flavonoid core, an amide 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 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 FormulaC25H31NO5
Molecular Weight425.52 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2000
Nitrogen Atoms1

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