Hydroxy urea

General Information

Hydroxyurea Impurities and Hydroxyurea

Daicel Pharma offers superior-quality Hydroxyurea impurities, such as 1-(carbamoyloxy)urea. These impurities are essential for evaluating Hydroxyurea quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Hydroxyurea impurities and ensures their worldwide delivery.
N-Hydroxyurea or Hydroxyurea [CAS: 127-07-1] is a urea analog and an antineoplastic agent. It is a cytostatic drug used in the preventive treatment of sickle cell disease. It is an antimetabolite that increases fetal Hemoglobin levels.

Hydroxyurea: Use and Commercial Availability

Hydroxyurea reduces the need for blood transfusion in pediatric patients with sickle cell anemia. It treats head and neck areas with resistant leukemias and carcinomas. In combination with other chemotherapeutic drugs, Hydroxyurea has many uses. Further, it is effective against ovarian cancer, acute myeloid leukemia, melanoma, polycythemia vera, etc. As a chemotherapeutic medicine, it has treated patients with myeloproliferative disorders for many years. Hydroxyurea is available under brands such as Droxia, Hydrea, Siklos, Xromi, etc. It occurs as an oral formulation.

Hydroxyurea Structure and Mechanism of Action

The chemical name of Hydroxyurea is Hydroxycarbamide. The chemical formula for Hydroxyurea is CH₄N₂O₂, and its molecular weight is approximately 76.05 g/mol.

Hydroxyurea, as a ribonucleotide reductase inhibitor, immediately blocks DNA synthesis, leading to cellular cytotoxicity.

Hydroxyurea Impurities and Synthesis

While synthesizing Hydroxyurea 1, impurities may form that will affect drug safety and efficacy. They form during the synthetic process, storage, or purification of Hydroxyurea. Manufacturers can control and monitor Hydroxyurea impurities to improve the drug’s safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Hydroxyurea impurities, which includes 1-(carbamoyloxy)urea. The CoA provided to clients is from a cGMP-compliant analytical facility with the complete characterization data2, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Hydroxyurea impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Hydroxyurea. Daicel Pharma provides a complete characterization report upon delivery.