General Information

Bendamustine Impurities and Bendamustine 

Daicel Pharma synthesizes high-quality Bendamustine impurities, including Bendamustine Glycerol Ester Impurity, Bendamustine Isopropyl Ester, Bendamustine HP-1 Impurity, Bendamustine Dihyroxy Impurity, Bendamustine N-Alkylated Impurity, Bendamustine USP Related Compound H and so on. These impurities are essential for evaluating the quality, stability, and safety of Bendamustine, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Bendamustine impurities for global delivery to meet the specific needs of our customers.

Bendamustine [CAS: 16506-27-7] is an alkylating agent that treats chronic lymphocytic leukemia and non-Hodgkin lymphoma. As a bifunctional mechlorethamine derivative, Bendamustine acts as an alkylating agent and an antimetabolite, providing dual therapeutic capabilities.

Bendamustine: Use and Commercial Availability  

Bendamustine is a medication to treat chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) that have not responded to treatment with rituximab or rituximab-containing regimens. Bendamustine is available under several trade names, including Belrapzo, Bendeka, Treanda, and Vivimusta.

Bendamustine Structure and Mechanism of Action

The chemical name of Bendamustine is 5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-butanoic acid. Its chemical formula is C₁₆H₂₁Cl₂N₃O_2, and its molecular weight is approximately 358.3 g/mol.

Bendamustine is a bifunctional bischlorethamine derivative that dissociates into electrophilic alkyl groups that covalently bind with electron-rich nucleophilic moieties leading to cell death.

Bendamustine Impurities and Synthesis

During the synthesis¹ and storage of Bendamustine, impurities that form include degradation products and residual solvents. These impurities can affect the drug’s safety and efficacy and harm patients. So, it is essential to control and monitor these impurities through proper analytical methods and quality control measures to ensure the drug’s purity, potency, and safety for clinical use. Regular testing of the drug substance and drug product can help identify and quantify any impurities and ensure they remain within acceptable limits.

Daicel Pharma provides a Certificate of Analysis (CoA) for Bendamustine impurity standards, including Bendamustine Glycerol Ester Impurity, Bendamustine Isopropyl Ester, Bendamustine HP-1 Impurity, Bendamustine Dihyroxy Impurity, Bendamustine N-Alkylated Impurity, Bendamustine USP Related Compound H and so on. The CoA is generated from a cGMP-compliant analytical facility and includes comprehensive characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We can also provide additional characterization data like 13C-DEPT and CHN upon request. Daicel Pharma is capable of creating unknown Bendamustine impurities or degradation products. Each delivery has a complete characterization report.