Sildenafil Impurity 54 CAS 133261-07-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.133261-07-1
Molecular FormulaC10H16N2O2
Molecular Weight196.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sildenafil Impurity 54 CAS 133261-07-1 chemical structure

Description

As a certified reference material (CRM), Sildenafil Impurity 54 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.

CATO supplies Sildenafil Impurity 54 (CAS 133261-07-1), a pharmacopoeial impurity reference standard (molecular formula C10H16N2O2, MW 196.25 g/mol) used for the identification and quantification of trace impurities in APIs.

Sildenafil Impurity 54 (C10H16N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC10H16N2O2
Molecular Weight196.25 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1995
Nitrogen Atoms2

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