Uraprotechconsultancy

Impurities of APIs

  • We have a synthesis method data base of about 500 impurities of approx. 150 APIs
  • We are supporting pharma companies by providing synthesis methods for in-house preparation of impurities of APIs and of its intermediates.
  • Identification of impurity’s structure based on 1H&13C NMR, Mass and IR.
  • We do impurity profiling, characterization of compounds and give structure characterization report for filing DMF, ANDA, NDA and NCE application.
  • Evaluation report for the possibility of nitrosoamine impurity formation in API.