Prucalopride Inhouse Impurity D
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  • Mumbai, India

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Enthält: HPLC, MASS/LC-MS, 1H-NMR, FT-IR, Gehalt, Structure Elucidation Report (SER) sowie zusätzliche analytische Daten je nach Produkt.

182808-04-4Prucalopride Inhouse Impurity D

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Katalog-Nr.::VE006181
CAS-Nr.::182808-04-4
Summenformel::C10H10ClNO3
Molare Masse::227.64 g/mol

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Zusätzliche Informationen zu CAS 182808-04-4

Parent drug

Prucalopride

IUPAC-Name

Methyl 4-Amino-5-chloro-2,3-dihydrobenzofuran-7-carboxylate

Synonyme

Prucalopride Related Compound 7

Pharmacopeial Synonyms

N/A

SMILES

O=C(C1=C(OCC2)C2=C(N)C(Cl)=C1)OC

InChI

InChI=1S/C10H10ClNO3/c1-14-10(13)6-4-7(11)8(12)5-2-3-15-9(5)6/h4H,2-3,12H2,1H3

Beschreibung

Prucalopride Impurity D (Prucalopride Related Compound 7, CAS 182808-04-4) is a process-related byproduct observed during prucalopride synthesis and stability studies. Characterization typically employs HPLC with UV detection, LC-MS for accurate mass confirmation, and NMR for structural assignment. This impurity can influence API purity, assay accuracy and stability profiles, therefore trace-level identification, quantification and qualification per ICH Q3A/B guidelines are essential. Control strategies include optimized reaction parameters, targeted purification steps and validated stability-indicating methods with defined acceptance criteria. Supply of well-characterized reference material supports method development, impurity profiling and regulatory submissions for pharmaceutical quality assurance.

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