Prucalopride Inhouse Impurity B
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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

182808-16-8Prucalopride Inhouse Impurity B

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Catalogue No.:VE006180
CAS No.:182808-16-8
Mol. Formula:C9H9ClN2O2
Mol. Weight:212.6 g/mol

Additional information on CAS 182808-16-8

Parent drug

Prucalopride

IUPAC Name

4-amino-5-chloro-2,3dihydro-1-benzofuran7-carboxamide

Synonyms

Prucalopride Related Compound 5

Pharmacopeial Synonyms

N/A

Smiles

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

InChI

InChI=1S/C9H9ClN2O2/c10-6-3-5(9(12)13)8-4(7(6)11)1-2-14-8/h3H,1-2,11H2,(H2,12,13)

Description

Prucalopride Impurity B (Prucalopride Related Compound 5), CAS 182808-16-8, is a process- and degradation-related impurity encountered during synthesis and stability testing of prucalopride. This structurally related compound is typically monitored by HPLC with UV detection and confirmed by LC-MS and NMR to support identification, profiling, and qualification. Analytical control strategies focus on establishing retention time, mass spectral signature, and impurity acceptance limits within regulatory guidance. Understanding formation pathways, such as incomplete reactions or hydrolytic degradation, supports mitigation via optimized reaction conditions and purification. Detailed characterization and routine monitoring are essential for quality control and ensuring pharmaceutical batch consistency.

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