Alumina depyrogenates F 18 fludeoxyglucose injection during purification processes
JF Cooper, NA Petry, H Engelbrecht… - PDA Journal of …, 2012 - journal.pda.org
Endotoxin indicators (EIs) and photometric bacterial endotoxin test (BET) assays were used
to determine the capacity of alumina (Al2O3) for removing endotoxin from a parenteral …
to determine the capacity of alumina (Al2O3) for removing endotoxin from a parenteral …
Inhibition evaluation for a 20-min endotoxin limit test on FDG
JC Hung, BC Iverson, MS Jacobson… - Nuclear medicine …, 2005 - journals.lww.com
Objectives In chemical quality control tests for 2-[18 F] fluoro-2-deoxy-D-glucose (18 F-FDG),
gel time is inversely related to endotoxin concentration. Solutions for positive product control …
gel time is inversely related to endotoxin concentration. Solutions for positive product control …
A rapid test for bacterial endotoxin quantification in 2-({sup 18} F) fluoro-2-deoxy-D-glucose by the kinetic chromogenic method
A Mitra, S Kulkarni, MGR Rajan - Indian Journal of Nuclear Medicine, 2010 - osti.gov
Full text: The Bacterial Endotoxin (BET) assay of 2-({sup 18} F) fluoro-2-deoxy-D-glucose
(({sup 18} F) FDG), if done prior to release, must be very quick to minimise radioactive decay …
(({sup 18} F) FDG), if done prior to release, must be very quick to minimise radioactive decay …
[HTML][HTML] Gel clot bacterial endotoxin test of FDG: Indian scenario
S Sharma, BR Mittal, R Vatsa… - Indian journal of nuclear …, 2011 - journals.lww.com
Background: The bacterial endotoxin test (BET) performed using gel clot method is a 60-min
test and typically performed after the decay of the 2-(18 F) fluoro-2-deoxy-d-glucose (F18 …
test and typically performed after the decay of the 2-(18 F) fluoro-2-deoxy-d-glucose (F18 …
Factors affecting quality control of [18F] FDG injection: bacterial endotoxins test, aluminum ions test and HPLC analysis for FDG and CIDG
R Nakao, T Kida, K Suzuki - Applied radiation and isotopes, 2005 - Elsevier
High concentrations of citrates and phosphates which are often used in the manufacturing of
[18F] fluro-d-glucose (FDG) preparations and wide deviation in the pH value from the neutral …
[18F] fluro-d-glucose (FDG) preparations and wide deviation in the pH value from the neutral …
Cycle development criteria for removal of endotoxin by dilution from glassware
D Berman, T Kasica, T Myers, S Chrai - PDA Journal of …, 1987 - journal.pda.org
A vial washing process is described for preparing clean, endotoxin-free glass parenteral
containers. This process is for 10-100–cc vial sizes with a 20-mm neck finish processed on …
containers. This process is for 10-100–cc vial sizes with a 20-mm neck finish processed on …
Depyrogenation of pharmaceutical solutions using submicron and ultrafilters
S Brown, AC Fuller - PDA Journal of Pharmaceutical Science and …, 1993 - journal.pda.org
The effect of varying the pH and ionic strength on endotoxin removal (depyrogenation) from
Water for Injections (WFI) was investigated. Studies using submicron filters showed that …
Water for Injections (WFI) was investigated. Studies using submicron filters showed that …
Rapid detection of bacterial endotoxin content in 18F-FDG injection
H Fu, X Zhang, J Zhang, Y He - Journal of Isotopes, 2017 - inis.iaea.org
[en] The American Endosafe-PTS detector of bacterial endotoxin was used to detecte 18 F-
FDG injection, and the results were compared to traditional spectrophotometric …
FDG injection, and the results were compared to traditional spectrophotometric …
Steam sterilization and automatic dispensing of [18F] fludeoxyglucose (FDG) for injection
P Karwath, J Sartor, W Gries, C Wodarski… - Applied radiation and …, 2005 - Elsevier
For the purpose of implementing steam sterilization of 2-[18F] FDG (FDG) in the final
container into routine production, we have validated and established a fully automated …
container into routine production, we have validated and established a fully automated …
[PDF][PDF] FDA Updates Medical Device Endotoxin Testing Program (new Guidance)
S Richter - Microtest Laboratories Inc, 2013 - researchgate.net
• Transfusion catheters• Intraocular lens implants• Cranial drills• Perfusion tubing• Dialysis
tubing and filters• Vascular grafts• In vitro fertilization catheters THE HISTORY Historically …
tubing and filters• Vascular grafts• In vitro fertilization catheters THE HISTORY Historically …