Prucalopride

Prucalopride Impurities

Prucalopride impurities include synthetic intermediates, process-related compounds, and degradation products that may arise during synthesis, formulation, or storage. As a selective serotonin 5-HT4 receptor agonist used for chronic idiopathic constipation, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Prucalopride EP Impurities

Pharmacopeial and non-pharmacopeial Prucalopride impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and stability testing. EP traceable materials include hydroxylated derivatives, N-oxides, and benzofuran analogs, supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Prucalopride Related Compounds

Structurally related compounds and synthetic analogs associated with Prucalopride are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Prucalopride Impurity Reference Standards

Prucalopride impurity reference standards are provided with validated analytical data including purity, NMR, and MS. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.