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[Investigation of the impurity profile of nifedipine by LC/MS]

T Karancsi, E Karaffa, L Ladányi

Acta Pharmaceutica Hungarica

|January 1, 1996

Abstract:

The manufacture-characteristic impurity profile of nifedipine drug substance was studied by HPLC and on-line LC/MS coupling. Using a new gradient HPLC procedure and MS detection, spectroscopic evidences for the chemical structure of some previously unknown minor impurities (all under 0.1%) were obtained.

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