Azacitidine
General Information
Azacitidine Impurities and Azacitidine
Daicel Pharma offers superior-quality Azacitidine impurities, such as Azacitidine Related Compound C / 1-Beta-D-Ribofuranosyl-3-Guanyl Urea Picrate. It is vital for evaluating Azacitidine quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Azacitidine impurities and ensures their worldwide delivery.
Azacitidine [CAS: 320-67-2] is also known as 5-azacytidine. It is a pyrimidine nucleoside analog. It is an antineoplastic agent that treats myeloid leukemia. Azacitidine inhibits DNA synthesis and methylation in replicating DNA. It treats French-American-British (FAB) myelodysplastic syndromes subtypes.
Azacitidine: Use and Commercial Availability
Azacitidine (Ladakamycin) treats acute myeloid leukemia (AML) in adults after their first complete remission. It is a part of continuous treatment in adults who are in remission with incomplete blood count recovery (Cri) after intensive induction chemotherapy. Further, it treats myelodysplastic syndrome subtypes such as refractory anemia with excess blasts, chronic myelomonocytic leukemia, and refractory anemia with ringed sideroblasts. Vidaza and Onureg are the brands of Azacitidine in injectable and oral formulations.
Azacitidine Structure and Mechanism of Action
The chemical name of Azacitidine is 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one. The chemical formula for Azacitidine is C8H12N4O5, and its molecular weight is approximately 244.21 g/mol.
Azacitidine causes DNA hypomethylation. Further, it causes cytotoxicity on the abnormal hematopoietic bone marrow cells.
Azacitidine Impurities and Synthesis
While synthesizing Azacitidine 1, impurities may form that will affect the safety and efficacy of the drug. These impurities form during Azacitidine synthesis, purification, storage, or degradation. Azacitidine impurities need control and monitoring to improve the drug’s safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Azacitidine impurities, which includes Azacitidine Related Compound C / 1-Beta-D-Ribofuranosyl-3-Guanyl Urea Picrate. A CoA is from a cGMP-compliant analytical facility. It contains the complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Azacitidine impurity or degradation product. In addition, Daicel Pharma offers highly purified stable isotope-labeled standards of Azacitidine for bioanalytical research and BA/BE studies. A complete characterization report is available on delivery.
References
FAQ's
References
- 1-glycosyl-5-azacytosines, GB1046181A, Mar 5, 1964, Ceskoslovenska Akademie Ved (https://www.lens.org/lens/search/patent/list?q=GB1046181)
- Rustum, Abu M.; Hoffman, Norman E., High-performance liquid chromatographic determination of 5-azacytidine in plasma, Journal of Chromatography, Biomedical Applications, Volume: 421, Issue: 2, Pages: 387-91, 1987 DOI: (1016/0378-4347(87)80422-x)
Frequently Asked Questions
2.How do Azacitidine process-related impurities form in the drug substance?
Azacitidine process-related impurities form during the quenching process. They also form due to the presence of silicon-containing coupling agents during synthesis.
3.Why is it necessary to identify Azacitidine impurities in drug substances?
It is vital to identify Azacitidine impurities in drug substances for drug safety, quality, and efficacy.
4.What are the known Azacitidine impurities found in drug substance?
4-amino-1-methyl-1,3,5-triazin-2- one and [(2R,3R,4R)-5- acetyloxy-3,4-dibenzoyl oxyoxolan-2-yl]methyl benzoate are the known Azacitidine impurities found in the drug substance.
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