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15057-73-5Flupentixol EP Impurity E (Free Base)

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Catalogue No.:	VE0025802
CAS No.:	15057-73-5
Mol. Formula:	C25H27F3N2O2S
Mol. Weight:	476.55 g/mol

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Additional information on CAS 15057-73-5

Parent drug

Flupentixol

IUPAC Name

2-[4-[3-[(EZ)-2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethyl acetate

Smiles

CC(OCCN(CC1)CCN1CC/C=C2C3=C(C=CC(C(F)(F)F)=C3)SC4=C/2C=CC=C4)=O

InChI

InChI=1S/C25H27F3N2O2S/c1-18(31)32-16-15-30-13-11-29(12-14-30)10-4-6-20-21-5-2-3-7-23(21)33-24-9-8-19(17-22(20)24)25(26,27)28/h2-3,5-9,17H,4,10-16H2,1H3/b20-6+

Description

Flupentixol EP Impurity E (Free Base), CAS 15057-73-5, is a specified process-related impurity of flupentixol characterized as the non-salt basic form arising from incomplete protonation or side reactions during synthesis. Analytical identification relies on HPLC with UV detection supported by LC-MS and NMR for structural confirmation and assay quantitation. Control strategies include optimization of workup pH, purification by recrystallization or chromatography, and established acceptance criteria within impurity profiling and stability testing. Routine monitoring is required to mitigate impacts on potency, batch-to-batch consistency, and regulatory compliance under European Pharmacopoeia guidelines.