Naloxone Hydrochloride EP Impurity E CAS 211738-08-8

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.211738-08-8
Molecular FormulaC38H40N2O8
Molecular Weight652.73 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Naloxone Hydrochloride EP Impurity E CAS 211738-08-8 chemical structure

Description

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.

CATO supplies Naloxone Hydrochloride EP Impurity E (CAS 211738-08-8), a pharmacopoeial impurity reference standard (molecular formula C38H40N2O8, MW 652.73 g/mol) used for the identification and quantification of trace impurities in APIs.

Naloxone Hydrochloride EP Impurity E (C38H40N2O8) contains a nitrogen-containing heterocyclic scaffold, 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC38H40N2O8
Molecular Weight652.73 g/mol
Purity>90%
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)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2017
Nitrogen Atoms2

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