Particulate matter in small volume parenterals: evaluation of some technological and analytical aspects.
The level of particulate contamination in water small volume injections available in Italy has been determined. The influence of the ampoule size, breaking system, manual method of ampoule opening and the type of instrument used for the determination have been evaluated. The distribution of the particles inside the batch of the sample was also studied.
Cirannni Signoretti
E
E
Montanari
I
I
Neri
G
G
De Sena
C
C
Alimonti
S
S
D004340:Drug Contamination; D004349:Drug Packaging; D005069:Evaluation Studies as Topic; D007263:Infusions, Parenteral; D010316:Particle Size