Data di Pubblicazione:
1988
Citazione:
Parenteral Solutions: Nature of Particulate Matter / E. SIGNORETTI, A. DELLUTRI, L. PAOLETTI, D. BATISTI, L. MONTANARI. - In: DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY. - ISSN 0363-9045. - 14:1(1988), pp. 1-12.
Abstract:
An investigation on the level and nature of particulate contamination in 36 large volume injectable solutions produced in Italy was performed, using Scanning Electron Microscopic (SEM) and X-ray microanalitic (EDS) techniques. Wide variability of the contaminant level, even within each individual batch, was observed. About 20% of the samples revealed a considerable amount of contaminants greater than 20 μm. Fibers of presumably textiles, cellulose or plastic materials were detected. Other particulate matter, from manifacturing and packaging processes, were observed.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
E. SIGNORETTI, A. DELLUTRI, L. PAOLETTI, D. BATISTI, L. MONTANARI
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