Allergenic impurities in medicinal preparations containing aminopenicillin. I. Ampicillin sodium
Betto, P.; Turchetto, L.; Longinotti, L.
Annali Dell'istituto Superiore di Sanita 25(2): 315-317
1989
ISSN/ISBN: 0021-2571 PMID: 2589732 Document Number: 334290
High-performance liquid chromatography (HPLC) with gradient elution has been used for the determination of degradation products in pharmaceutical preparations containing sodium ampicillin. In all preparations resulting by lyophilization process, the degradation products amount, almost exclusively constituted of allergenic polymeric substances deriving from condensation reactions, is more than 10%. On the contrary, the sodium ampicillin prepared by precipitation in non aqueous solvents, only contains the 2% of polymeric impurities.