Valbenazine Impurity 4 CAS 1025504-59-9

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.1025504-59-9
Molecular FormulaC24H38N2O4
Molecular Weight418.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Valbenazine Impurity 4 CAS 1025504-59-9 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Valbenazine Impurity 4.

CATO supplies Valbenazine Impurity 4 (CAS 1025504-59-9), a pharmacopoeial impurity reference standard (molecular formula C24H38N2O4, MW 418.57 g/mol) used for the identification and quantification of trace impurities in APIs.

Valbenazine Impurity 4 (C24H38N2O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC24H38N2O4
Molecular Weight418.57 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity≥95%
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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Nitrogen Atoms2

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