Sildenafil Impurity 55 CAS 92945-27-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.92945-27-2
Molecular FormulaC9H14N2O2
Molecular Weight182.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sildenafil Impurity 55 CAS 92945-27-2 chemical structure

Description

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.

Sildenafil Impurity 55 (CAS 92945-27-2) is a certified pharmaceutical impurity reference standard with the molecular formula C9H14N2O2 and a molecular weight of 182.22 g/mol.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Sildenafil Impurity 55 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 182.22 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Sildenafil Impurity 55 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 FormulaC9H14N2O2
Molecular Weight182.22 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.)1983
Nitrogen Atoms2

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