Tenofovir Disoproxil Impurity 46 CAS CATO-C4X-107646

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-107646
Molecular FormulaC13H21O6PS
Molecular Weight336.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tenofovir Disoproxil Impurity 46 CAS CATO-C4X-107646 chemical structure

Description

As a certified reference material (CRM), Tenofovir Disoproxil Impurity 46 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.

As a process- or degradation-related impurity, Tenofovir Disoproxil Impurity 46 (CAS CATO-C4X-107646, C13H21O6PS) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Tenofovir Disoproxil Impurity 46 (C13H21O6PS) is characterized by a sulfone group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional 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.

Physical & Chemical Properties

Molecular FormulaC13H21O6PS
Molecular Weight336.34 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.5
UV AbsorptionUV-absorbing
Sulfur Atoms1

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