Tenofovir Disoproxil Impurity 15 CAS 365417-53-4(Free Base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.365417-53-4(Free Base)
Molecular FormulaC18H28N5O10P
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tenofovir Disoproxil Impurity 15 CAS 365417-53-4(Free Base) 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 Tenofovir Disoproxil Impurity 15.

CATO supplies Tenofovir Disoproxil Impurity 15 (CAS 365417-53-4(Free Base)), a pharmacopoeial impurity reference standard (molecular formula C18H28N5O10PC4H4O4, MW 621.49 g/mol) used for the identification and quantification of trace impurities in APIs.

Tenofovir Disoproxil Impurity 15 (C18H28N5O10PC4H4O4) contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

CATO manufactures Tenofovir Disoproxil Impurity 15 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC18H28N5O10P C4H4O4
Molecular Weight621.49 g/mol
Purity>95%
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
Nitrogen Atoms5

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