Dapoxetine Impurity 85 CAS 2245197-11-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2245197-11-7
Molecular FormulaC28H26O2
Molecular Weight394.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dapoxetine Impurity 85 CAS 2245197-11-7 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 Dapoxetine Impurity 85.

Dapoxetine Impurity 85 (CAS 2245197-11-7) is a certified pharmaceutical impurity reference standard with the molecular formula C28H26O2 and a molecular weight of 394.50 g/mol.

The molecular framework of Dapoxetine Impurity 85 (C28H26O2) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Dapoxetine Impurity 85 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 FormulaC28H26O2
Molecular Weight394.50 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1998

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