Tenofovir Disoproxil Impurity 44 CAS 201340-97-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.201340-97-8
Molecular FormulaC18H28N5O10P
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tenofovir Disoproxil Impurity 44 CAS 201340-97-8 chemical structure

Description

CATO supplies Tenofovir Disoproxil Impurity 44 (CAS 201340-97-8), a pharmacopoeial impurity reference standard (molecular formula C18H28N5O10PC4H4O4, MW 621.49 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, Tenofovir Disoproxil Impurity 44 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 621.49 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Disoproxil Impurity 44 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 FormulaC18H28N5O10P C4H4O4
Molecular Weight621.49 g/mol
Purity97%+
StorageStore in a cool place (≤25°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
CAS Registry Year (est.)2014
Nitrogen Atoms5

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