Risdiplam

Risdiplam Impurities

Risdiplam impurities include synthetic intermediates, process-related compounds, degradation products, and nitrosamine contaminants. These may arise during synthesis, formulation, or long-term storage. As an orally bioavailable mRNA splicing modifier used in the treatment of spinal muscular atrophy (SMA), 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.

Risdiplam EP Impurities

Pharmacopeial and non-pharmacopeial Risdiplam 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 pyridazine derivatives, spirocyclic analogs, and oxidized variants, supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Risdiplam Related Compounds

Structurally related compounds and synthetic analogs associated with Risdiplam 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.

Risdiplam Impurity Reference Standards

Risdiplam impurity reference standards are provided with validated analytical data including purity, NMR, MS, and full Certificates of Analysis. 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.