Naltrexone EP Impurity A CAS 1007856-83-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1007856-83-8
Molecular FormulaC17H17NO5
Molecular Weight315.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Naltrexone EP Impurity A CAS 1007856-83-8 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.

Naltrexone EP Impurity A (CAS 1007856-83-8) is a certified pharmaceutical impurity reference standard with the molecular formula C17H17NO5 and a molecular weight of 315.32 g/mol.

Structurally, Naltrexone EP Impurity A (C17H17NO5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 315.32 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC17H17NO5
Molecular Weight315.32 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.)1988
Nitrogen Atoms1

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