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Isolation of Low Level Impurity

Objective

  • Isolation of impurity present in low level (0.1% area by HPLC-UV)

  • Starting material contained only 0.1% of target impurity
  • The original method obtained from our customer was not applicable for a mass directed purification and MS detection
  • Modification of original method by means of appropriate mobile phase with volatile modifiers
  • Purification process was divided into two steps
  • Obtained enriched material contained about 65% of target impurity
  • For re-purification step focused gradient method was developed
  • The final purity of isolated impurity was 95% Area by LC-MS
  • The structure of isolated impurity was determined by NMR, HRMS and H/D exchange experiments
  • Delivered amount of isolated target impurity was 100 mg

 
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