Capecitabine Impurities

General Information

Capecitabine Impurities and Capecitabine

Daicel Pharma offers high-quality Capecitabine impurities, Capecitabine EP impurity D, Capecitabine EP impurity E, and Capecitabine Isomers Mixture. They are vital for evaluating the quality, stability, and biological safety of Capecitabine. Furthermore, Daicel Pharma specializes in the custom synthesis of Capecitabine impurities and ensures their worldwide delivery.

Capecitabine [CAS: 154361-50-9] is an antineoplastic agent for cancer treatment. It belongs to the category of carbamate esters. It is a prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) and converted to 5-fluorouracil.

Capecitabine: Use and Commercial Availability

Capecitabine is a fluoropyrimidine carbamate, a type of antineoplastic agent. It treats patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen. Capecitabine, marketed under the brand name Xeloda, is utilized as an antimetabolite in the treatment of colon cancer, breast cancer, and gastric cancer.

Capecitabine Structure and Mechanism of Action

The chemical name of Capecitabine is 5′-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine. The chemical formula for Capecitabine is C₁₅H₂₂FN₃O₆, and its molecular weight is approximately 359.35g/mol.

Capecitabine activation is by tumor cells selectively to its cytotoxic moiety, 5-fluorouracil (5-FU). Further, 5-FU metabolizes to two active metabolites, 5-fluoro-2-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP).

Capecitabine Impurities and Synthesis

While synthesizing Capecitabine¹, stringent protocols can uphold its purity and effectiveness. However, impurities may arise during the process, posing challenges to drug quality. Advanced purification methods such as chromatography and crystallization can mitigate impurities. Continuous vigilance and adherence to rigorous quality control measures are imperative to ensure the integrity of Capecitabine throughout its synthesis.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Capecitabine impurities, which includes Capecitabine EP impurity D, Capecitabine EP impurity E, and Capecitabine Isomers Mixture. The CoA is from a cGMP-compliant analytical facility and encompasses complete characterization data such as 1H NMR, 13C NMR², IR, MASS, and HPLC purity. On request, we give additional data like 13C-DEPT and CHN. Daicel Pharma also prepares any unidentified Capecitabine impurity or degradation product. Furthermore, Daicel Pharma offers highly purified isotope-labeled standards of Capecitabine for bioanalytical research and BA/BE studies. We provide a complete characterization report upon delivery.