Cladribine

Cladribine Impurities

Cladribine is a purine nucleoside analog used in the treatment of certain leukemias and multiple sclerosis. Its impurity profile includes structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. Degradation pathways typically involve cleavage of the glycosidic bond, deamination of the purine ring, and oxidative breakdown of the chlorinated adenine moiety. These impurities may affect the drug’s potency, stability, and safety. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Cladribine EP Impurities

Pharmacopeial and non-pharmacopeial Cladribine impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.

Cladribine Related Compounds

Structurally related compounds and synthetic analogs associated with Cladribine are included for use in impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.

Cladribine Impurity Reference Standards

Cladribine 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.