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Bendamustine Acetate Impurity

  • CAT Number DCTI-C-002
  • CAS Number NA
  • Molecular Formula C18H24ClN3O4
  • Molecular Weight 381.86

Bendamustine Dihyroxy Impurity

  • CAT Number DCTI-C-555
  • CAS Number 109882-30-6
  • Molecular Formula C16H23N3O4
  • Molecular Weight 321.38

Bendamustine Glycerol Ester Impurity

  • CAT Number DCTI-C-001
  • CAS Number NA
  • Molecular Formula C19H27Cl2N3O4
  • Molecular Weight 432.34

Bendamustine HP-1 Impurity

  • CAT Number DCTI-C-494
  • CAS Number 109882-27-1
  • Molecular Formula C16H22ClN3O3
  • Molecular Weight 339.82

Bendamustine Isopropyl Ester

  • CAT Number DCTI-C-557
  • CAS Number 1313020-25-5
  • Molecular Formula C19H27Cl2N3O2
  • Molecular Weight 400.34

Bendamustine methyl ester

  • CAT Number DCTI-C-678
  • CAS Number 109882-25-9
  • Molecular Formula C17H23Cl2N3O2
  • Molecular Weight 372.29

Bendamustine N-Alkylated Impurity

  • CAT Number DCTI-C-553
  • CAS Number 1797881-48-1
  • Molecular Formula C14H19Cl2N3O2 (HCl Salt) C14H18ClN3O2 (Free base)
  • Molecular Weight 332.23 (HCl Salt) 295.77 (Free base)

Bendamustine Related Compound B

  • CAT Number DCTI-C-554
  • CAS Number 1228552-02-0
  • Molecular Formula C16H21N3O3
  • Molecular Weight 303.36

Bendamustine Related Compound C

  • CAT Number DCTI-C-556
  • CAS Number 3543-74-6
  • Molecular Formula C18H25Cl2N3O2
  • Molecular Weight 349.43
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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 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 C16H21Cl2N3O2, 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.


Frequently Asked Questions

Residual solvents in Bendamustine are impurities that linger after the synthetic process and can be harmful if present in high amounts.

The control of process-related impurities in Bendamustine is possible by using high-quality starting materials, optimizing reaction conditions, and implementing the correct purification steps.

Methanol or DMSO are solvents used in analyzing many impurities in Bendamustine.

Bendamustine impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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