Ruxolitinib

Ruxolitinib Impurities

Ruxolitinib impurities include synthetic intermediates, process-related compounds, degradation products, and nitrosamine derivatives that may arise during synthesis, formulation, or storage. As a selective Janus kinase (JAK1/JAK2) inhibitor used in the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease, 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.

Ruxolitinib EP Impurities

Pharmacopeial and non-pharmacopeial Ruxolitinib 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 are supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Ruxolitinib Related Compounds

Structurally related compounds and synthetic analogs associated with Ruxolitinib 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.

Ruxolitinib Impurity Reference Standards

Ruxolitinib 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.