Tenofovir Alafenamide Impurity 65 CAS CATO-C4X-179765

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-179765
Molecular FormulaC16H20N5O4P
Molecular Weight377.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tenofovir Alafenamide Impurity 65 CAS CATO-C4X-179765 chemical structure

Description

As a process- or degradation-related impurity, Tenofovir Alafenamide Impurity 65 (CAS CATO-C4X-179765, C16H20N5O4P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Tenofovir Alafenamide Impurity 65 (C16H20N5O4P) is characterized by a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), Tenofovir Alafenamide Impurity 65 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 FormulaC16H20N5O4P
Molecular Weight377.33 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>90%
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)9.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms5

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