Roxatidine Impurity 50 CAS 78274-00-7 (free base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.78274-00-7 (free base)
Molecular FormulaC16H24N2O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxatidine Impurity 50 CAS 78274-00-7 (free base) 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 Roxatidine Impurity 50.

CATO supplies Roxatidine Impurity 50 (CAS 78274-00-7 (free base)), a pharmacopoeial impurity reference standard (molecular formula C16H24N2O2HCl, MW 312.84 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Roxatidine Impurity 50 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 312.84 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

CATO manufactures Roxatidine Impurity 50 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC16H24N2O2 HCl
Molecular Weight312.84 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

Related Roxatidine Standards

Recommended Standards

Why CATO?