Particulate contamination in solutions of antibiotics packed as dry powders in vials

Abstract

Abstract The particulate contamination in 12 formulations of antibiotic solutions in vials packed as dry powders from five South African sources has been analysed quantitatively using a HIAC PC 320 light blockage particle analyser linked to a CMB 60 sensor. Results showed that the level of particulate contamination fell well within the limits set by the USP XXIst Edition for Small Volume Parenterals although four formulations contained some particles ≥50 μm. There was no apparent difference between the quality of the same antibiotics from different sources or between vials of the same antibiotics packed in different strengths.