Impurity synthesis & analysis

Case Study 6 – Major Pharma Client

 

  • Celtic Catalysts undertook synthesis of a potentially mutagenic impurity of contained in client’s pipeline drug .
  • Celtic Catalysts subsequently produced 100s of grams of a metabolite and other impurities.
  • Celtic Catalysts designed a protocol and ran analysis to enable quantification of this impurity in batch runs.
  • Subsequently redeveloped a key step of the process to avoid any chance of producing this impurity

 

 
© 2012 Celtic Catalysts

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