Janko Žmitek*, Rok Grahek, Teofil Žižek, Borut Furlan,
LEK d.d., Verovškova 57, 1526 Ljubljana, SLOVENIA

ABSTRACT

General consideration of  possible sources of impurities in organic synthesis products is presented, distinguishing between primary and secondary impurities. By an investigation of impurity 3 in amlodipine besylate 1 it is shown that  packaging and process equipment materials, involved in a synthesis, can be additional source of impurities. It was found that impurity 3 can be formed by reaction between amlodipine besylate 1 and bis(2-ethylhexyl) phtalate (2) eluted from plastic materials used for storage of solvents for the amlodipine besylate synthesis. A selective and sensitive HPLC-MS/MS method was developed  for this investigation.