A Portable Test System for Determination of Bacterial Endotoxins in 18F-FDG, 99mTc, and Lyophilized Reagents for Labeling with 99mTc

Abstract

The portable test system is a rapid, simple, and accurate technique using the quantitative kinetic chromogenic method for bacterial endotoxin determination. For this reason, the test is practical for radiopharmaceutical uses and tends to be the method of choice for the pyrogen test. For (18)F-FDG, (99m)Tc, MDP, and pyrophosphate, the validation was successfully performed.

Development and characterization of DTPA-trastuzumab conjugates for radiolabeling with Tc-99m: A radiopharmaceutical for HER2/neu breast cancer

“…No growth after incubation in the broth was observed for up to seven days. The endotoxin levels in the preparations as determined by PTS system were (60e113 EU/mL; mean 86 ± 21) within the acceptable limits (<175 EU/mL) [20,21].…”

Plasma endotoxin activity in Eastern grey kangaroos (<i>Macropus giganteus</i>) with lumpy jaw disease

“…Spike recovery values are considered valid, if they are between 50 and 200% according to the Bacterial Endotoxin Test in the US Pharmacopeia [20]. USP chapter 85 [20], which addresses photometric bacterial endotoxin test methods, allows for a wide recovery range for the positive control, between 50 and 200%, because small discrepancies in test conditions and cartridge flaws contribute to variable recovery values for the positive control [8, 11, 12, 16]. The absolute value of the correlation coefficient of the standard curve generated using reference standard endotoxin was greater than or equal to 0.980 for the range of endotoxin concentrations established according to the Bacterial Endotoxin Test in the US Pharmacopeia [20].…”

“…The absolute value of the correlation coefficient of the standard curve generated using reference standard endotoxin was greater than or equal to 0.980 for the range of endotoxin concentrations established according to the Bacterial Endotoxin Test in the US Pharmacopeia [20]. When any criterion, mainly the recovery of the positive control, was not within the acceptable range, the test was not considered to be valid [11]. In this study, the LAL-KT assay effectively recovered endotoxin from plasma, the linearity of the standard curve and its CV were satisfactory for the KT assay over the range of concentrations tested [19].…”

Detecting endotoxin activity in bovine serum using an automated testing system

“…This automated miniaturized kinetic chromogenic LAL-based assay (the Endosafe ® PTS TM ) delivers results in 15 min. The concentration of endotoxin in each sample is determined by the degree of color intensity [ 1 , 4 , 5 , 6 ]. Unlike the PTS TM , the traditional toxinometer [ 9 ], LAL-kinetic turbidimetric (KT) and chromogenic (KC) assays [ 5 ] require 75% to 85% more processing time.…”

“…Statistical analysis : A test result was considered valid when spike recovery and coefficient of variation (CV) parameters met the accepted criteria (<25%) established by the Endosafe ® PTS TM and traditional LAL methods. Spike recovery values were considered valid, if the results were between 50% and 200% according to the Bacterial Endotoxin Test in the US pharmacopeia [ 1 , 4 , 5 , 6 ].…”