[Allergenic impurities in medicinal preparations containing aminopenicillin. I. Ampicillin sodium]

Ann Ist Super Sanita. 1989;25(2):315-7.
[Article in Italian]

Abstract

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.

Publication types

  • Comparative Study
  • English Abstract

MeSH terms

  • Allergens / analysis*
  • Ampicillin / analysis*
  • Ampicillin / standards
  • Chemical Precipitation
  • Chromatography, High Pressure Liquid
  • Drug Compounding
  • Drug Contamination
  • Freeze Drying
  • Polymers

Substances

  • Allergens
  • Polymers
  • Ampicillin