Dasatinib Impurities

Dasatinib, sold under the brand name Sprycel among others, is a targeted therapy medication used to treat certain cases of chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL). Specifically it is used to treat cases that are Philadelphia chromosome-positive (Ph+). It is taken by mouth.

Common adverse effects include low white blood cells, low blood platelets, anemia, swelling, rash, and diarrhea. Severe adverse effects may include bleeding, pulmonary edema, heart failure, and prolonged QT syndrome. Use during pregnancy may result in harm to the baby. It is a tyrosine-kinase inhibitor and works by blocking a number of tyrosine kinases such as Bcr-Abl and the Src kinase family.

Dasatinib was approved for medical use in the United States and in the European Union in 2006. It is on the World Health Organization's List of Essential Medicines.




List of Impurities of Dasatinib



Other Reference Standards of Dasatinib


What is Dasatinib Impurities?

  • Dasatinib Impurities are the components of Dasatinib which are not the defined active substance of Dasatinib
  • They are unwanted chemicals that remain with active pharmaceutical ingredients of Dasatinib
  • Some of Dasatinib Impurities can be used for evaluating data that establishes quality
  • They are also used for stability and biological safety of pharmaceutical products
  • Dasatinib Impurities can also be used for ANDA / DMF filling and genotoxicity studies.


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