RT Journal Article
SR Electronic
T1 Pyrogens in Small-Volume Parenterals Prepared in Hospital Pharmacy
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 246
OP 249
VO 43
IS 5
A1 C. Lacasa
A1 F. A. Vega
YR 1989
UL http://journal.pda.org/content/43/5/246.abstract
AB Three pyrogen assay methods [the rabbit method, Limulus Amebocyte Lysate (LAL) gelation and chromogenic substrate, and bioburden prior to sterilization] were evaluated in three standard batches of small-volume parenteral preparations; i.e., water for injection, sodium chloride 0.9% injection, and sodium bicarbonate 8.4% injection. The same preparations were also assayed after contamination with Escherichia coli followed by sterilization. All methods gave the same results with the water for injection and the sodium chloride 0.9%. With sodium bicarbonate 8.4%, only the rabbit method was valid. For sodium chloride 0.9%, the chromogenic substrate method was valid; the gelation method was not valid. Endotoxins from the manufacturing plant were less pyrogenic in rabbits than were standard endotoxins or those from hospital E. coli.