Dexrazoxane Impurities

General Information

Dexrazoxane Impurities and Dexrazoxane

Daicel Pharma synthesizes Dexrazoxane impurities of exceptional quality, such as Dexrazoxane Impurity-A, Dexrazoxane Impurity-C, and Dexrazoxane Impurity-D. These impurities are crucial to assess the purity, reliability, and safety of Dexrazoxane, an active pharmaceutical ingredient. Besides, Daicel Pharma provides custom synthesis of Dexrazoxane impurities to meet clients’ demands for delivery worldwide.

Dexrazoxane [CAS: 24584-09-6], the (+)-enantiomorph of razoxane, exhibits iron-chelating, chemoprotective, cardioprotective, and antineoplastic properties. It acts as an antimitotic agent while also possessing immunosuppressive effects. Dexrazoxane provides cardioprotection against anthracycline toxicity by inhibiting the formation of a toxic iron-anthracycline complex.

Dexrazoxane: Use and Commercial Availability  

Dexrazoxane, an FDA-approved cardioprotective drug, has demonstrated its effectiveness in managing cardiac toxicity associated with anthracycline-based chemotherapy in cancer patients, particularly those with advanced breast cancer, soft tissue sarcomas, or small-cell lung cancer. It treats tissue damage caused by anthracyclines. Dexrazoxane is available under brand names, including Totect and Zinecard.

Dexrazoxane Structure and Mechanism of Action

The chemical name of Dexrazoxane is 4,4′-[(1S)-1-Methyl-1,2-ethanediyl]bis[2,6-piperazinedione]. Its chemical formula is C₁₁H₁₆N₄O_4, and its molecular weight is approximately 268.27 g/mol.

Dexrazoxane readily penetrates cell membranes and is a cyclic derivative of EDTA.

Dexrazoxane Impurities and Synthesis

During the synthesis¹ of Dexrazoxane, impurities generate as byproducts. They may originate from starting materials, reagents, or reaction intermediates used in manufacturing. It is necessary to identify and characterize these impurities to ensure the purity and safety of the final product. Analytical techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS) help in impurity profiling and quantification. Manufacturers of Dexrazoxane closely monitor impurities to meet regulatory standards and implement purification methods to minimize their presence, ensuring the highest quality of the drug for therapeutic use.

Daicel Pharma offers a Certificate of Analysis (CoA) for Dexrazoxane impurity standards, such as Dexrazoxane Impurity-A, Dexrazoxane Impurity-C, and Dexrazoxane Impurity-D, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Furthermore, on request, we give additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Dexrazoxane impurities or degradation products. A complete characterization report accompanies every delivery.