Impurities in drugs I: Imipramine, desipramine, and their formulations.
Nineteen lots of imipramine tablets and four lots of desipramine tablets were examined for impurities by TLC. Iminodibenzyl, desipramine, and 10,11-dihydro-5-[3-(methylamino-3'-dimethylaminopropyl)propyl]-5H-dibenz[b,f]azepine dihydrobromide (I) were found in some imipramine tablets, and iminodibenzyl and imipramine were found in some desipramine tablets, all at levels of less than 0.3% of label claim of the drug. Except for I, the identity of the impurities was established by comparison with known standards; I was synthesized and its composition was established by elemental analysis. All impurities, including I, were characterized by TLC, GLC, and mass spectrometry.
D002214:Capsules / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D002849:Chromatography, Gas; D002855:Chromatography, Thin Layer; D003891:Desipramine / Q000032:analysis*; D004340:Drug Contamination; D007099:Imipramine / Q000032:analysis*; D013607:Tablets / Q000032:analysis
D002214:Capsules; D013607:Tablets; D007099:Imipramine; D003891:Desipramine