Naltrexone Impurity 68 CAS 207732-98-7

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.207732-98-7
Molecular FormulaC21H22N2O3
Molecular Weight350.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Naltrexone Impurity 68 CAS 207732-98-7 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 Naltrexone Impurity 68.

Naltrexone Impurity 68 (CAS 207732-98-7) is a certified pharmaceutical impurity reference standard with the molecular formula C21H22N2O3 and a molecular weight of 350.41 g/mol.

Based on its molecular formula C21H22N2O3, Naltrexone Impurity 68 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 350.41 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 68 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 FormulaC21H22N2O3
Molecular Weight350.41 g/mol
AppearancePale yellow to 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2016
Nitrogen Atoms2

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