Cytarabine

Cytarabine Impurities

Cytarabine (also known as Ara-C) is an antimetabolite chemotherapy agent that is generally used in the treatment of acute myeloid leukemia (AML) and other hematologic malignancies. Its impurity profile includes structurally related analogs, residual solvents, and degradation products. These impurities can be formed under stress conditions such as hydrolysis, oxidation, and photolysis. Typical degradation pathways of Cytarabine involve hydrolytic cleavage of the cytosine-arabinose glycosidic bond, oxidative breakdown of the cytosine ring, and rearrangement of substituents within the nucleoside scaffold. These impurities may affect the potency, stability, and safety of the drug. Hence all impurities are structurally characterized and qualified according to ICH guidelines for toxicological assessment and analytical validation.

Cytarabine EP Impurities

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

Cytarabine Related Compounds

We synthesize structurally related compounds, and synthetic analogs of Cytarabine are included for 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.

Cytarabine Impurity Reference Standards

We also prove Cytarabine impurity reference standards 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. The EP/USP traceable products are available upon request and are routinely re-tested to ensure consistency and reliability.