Tofacitinib

Tofacitinib Impurities

Tofacitinib impurities include synthetic intermediates, process-related compounds, degradation products, and potential nitrosamine contaminants. These may arise during synthesis, formulation, or long-term storage. As a Janus kinase (JAK) inhibitor used in autoimmune conditions such as rheumatoid arthritis and ulcerative colitis, impurity profiling is essential to ensure therapeutic safety, efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Tofacitinib EP Impurities

Pharmacopeial and non-pharmacopeial Tofacitinib 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.

Tofacitinib Related Compounds

Structurally related compounds and synthetic analogs associated with Tofacitinib 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.

Tofacitinib Impurity Reference Standards

Tofacitinib 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.