Perphenazine EP Impurity A CAS 10078-25-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.10078-25-8
Molecular FormulaC21H26ClN3O2S
Molecular Weight419.97 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Perphenazine EP Impurity A CAS 10078-25-8 chemical structure

Description

The occurrence of Perphenazine EP Impurity A is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Perphenazine EP Impurity A (CAS 10078-25-8) is a certified pharmaceutical impurity reference standard with the molecular formula C21H26ClN3O2S and a molecular weight of 419.97 g/mol.

Structurally, Perphenazine EP Impurity A (C21H26ClN3O2S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 419.97 g/mol, it falls into the moderately-high-molecular-weight range. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC21H26ClN3O2S
Molecular Weight419.97 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1959
Halogen ContentCl-containing
Nitrogen Atoms3
Sulfur Atoms1

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