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Prucalopride Degradation Product (Hydrate)

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Katalog-Nr.::	VE0025864
CAS-Nr.::	N/A
Summenformel::	C30H48ClN3O14
Molare Masse::	710.17 g/mol

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Zusätzliche Informationen zu Prucalopride Degradation Product

Parent drug

Prucalopride

IUPAC-Name

5-chloro-4-((3,4-dihydroxy-6-(hydroxymethyl)-5-((3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2-yl)amino)-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide hydrate

Pharmacopeial Synonyms

N/A

SMILES

OCC1C(O)C(O)C(O)C(OC2C(CO)OC(NC3=C(Cl)C=C(C(NC4CCN(CCCOC)CC4)=O)C5=C3CCO5)C(O)C2O)O1

InChI

InChI=1S/C30H46ClN3O13/c1-43-9-2-6-34-7-3-14(4-8-34)32-28(42)16-11-17(31)20(15-5-10-44-26(15)16)33-29-24(40)23(39)27(19(13-36)45-29)47-30-25(41)22(38)21(37)18(12-35)46-30/h11,14,18-19,21-25,27,29-30,33,35-41H,2-10,12-13H2,1H3,(H,32,42)

Synonyme

N/A

Other Synonyms

N/A

Beschreibung

Prucalopride degradation product identified as a Prucalopride lactose adduct hydrate is a process and storage related impurity formed by interaction between the active amine moiety and lactose excipient under heat and moisture. It is characterized by a defined mass increase and distinctive LC-MS fragmentation together with unique NMR signals for glycosylated adduct formation. Stability indicating HPLC and UHPLC-MS methods enable quantitation and forced degradation studies, while isolation and solid state analysis confirm hydrate stoichiometry. Control strategies include excipient selection, moisture control, and specification limits aligned with ICH impurity guidance to mitigate impact on drug purity and analytical release criteria.