Naltrexone Impurity N4 CAS 16676-33-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.16676-33-8
Molecular FormulaC21H25NO4
Molecular Weight355.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Naltrexone Impurity N4 CAS 16676-33-8 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 355.43 g/mol gives Naltrexone Impurity N4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Naltrexone Impurity N4 (CAS 16676-33-8) is a certified pharmaceutical impurity reference standard with the molecular formula C21H25NO4 and a molecular weight of 355.43 g/mol.

Naltrexone Impurity N4 (C21H25NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. 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).

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.

As a certified reference material (CRM), Naltrexone Impurity N4 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC21H25NO4
Molecular Weight355.43 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Nitrogen Atoms1

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