Roxatidine Impurity 38 CAS CATO-C4X-121338

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-121338
Molecular FormulaC18H26N2O4
Molecular Weight334.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxatidine Impurity 38 CAS CATO-C4X-121338 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.

CATO supplies Roxatidine Impurity 38 (CAS CATO-C4X-121338), a pharmacopoeial impurity reference standard (molecular formula C18H26N2O4, MW 334.41 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Roxatidine Impurity 38 (C18H26N2O4) 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

Physical & Chemical Properties

Molecular FormulaC18H26N2O4
Molecular Weight334.41 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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