Chlorambucil
General Information
Chlorambucil Impurities and Chlorambucil
Daicel Pharma synthesizes and offers superior-quality Chlorambucil impurities, which include Chlorambucil EP Impurity E. It is vital for evaluating Chlorambucil quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Chlorambucil impurities and ensures worldwide delivery.
Chlorambucil [CAS: 305-03-3] is an alkylating agent in chemotherapy treatment. It disrupts DNA function and causes cell death. Chlorambucil treats various types of cancer, such as chronic lymphocytic leukemia (CLL) and Hodgkin lymphoma. As a nitrogen mustard alkylating agent, it binds to the DNA of tumor cells and exerts its biological activity.
Chlorambucil: Use and Commercial Availability
Chlorambucil is an anti-cancer medicine and an alkylating agent. It treats patients with chronic lymphocytic leukemia, malignant lymphomas including lymphosarcoma, Hodgkin’s disease, non-Hodgkin’s lymphomas, giant follicular lymphoma, and Waldenström’s Macroglobulinemia. It is an immunosuppressant and treats conditions such as uveitis and nephrotic syndrome. Chlorambucil is available as oral medicine under brands such as Leukeran, Ambochlorin, etc.
Chlorambucil Structure and Mechanism of Action
The chemical name of Chlorambucil is 4-[Bis(2-chloroethyl)amino]benzenebutanoic acid. The chemical formula for Chlorambucil is C14H19ClNO2, and its molecular weight is approximately 304.21 g/mol.
Chlorambucil interferes with RNA transcription and DNA replication and nucleic acid function disruption. In addition, it suppresses lymphocytes.
Chlorambucil Impurities and Synthesis
When synthesizing Chlorambucil 1, the formation of impurities may affect drug safety and efficacy. They form during the synthetic process, storage, or purification of Chlorambucil. Chlorambucil impurities need control and monitoring to improve the drug safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Chlorambucil impurities, which includes Chlorambucil EP Impurity E. 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 Chlorambucil impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Chlorambucil. Daicel Pharma provides a complete characterization report accompanying the delivery.
References
FAQ's
References
- Ross, Walter C. J.; Everett, James L.; Roberts, John J., Improvements in or relating to chemotherapeutic agents, GB727336A, Mar 30, 1955, National Research Development Corp. (https://www.lens.org/lens/search/patent/list?q=GB727336)
- Newell, David R.; Hart, Leigh I.; Harrap, Kenneth R., Estimation of chlorambucil, phenyl acetic mustard and prednimustine in human plasma by high-performance liquid chromatography, Journal of Chromatography, Biomedical Applications, Volume: 164, Issue: 1, Pages: 114-9, 1979, DOI: (10.1016/s0378-4347(00)81580-7)
Frequently Asked Questions
2. What happens if residual solvents remain in the Chlorambucil drug product?
The presence of residual solvents in Chlorambucil drug product can be toxic and carcinogenic for humans. Thus, these impurities have to be removed from the drug.
3. What causes the degradation of Chlorambucil?
Intense light and moisture can cause the degradation of Chlorambucil.
4. Which analytical method identifies the degradation product of Chlorambucil?
Reversed-phase high-pressure liquid chromatography (RP-HPLC) identifies the degradation product of Chlorambucil.
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