The LAL Clotting Reaction 1
The substance that initiates the LAL reaction
What is endotoxin
The greatest dilution at which the endotoxin limit can be detected
What is the maximum valid dilution (MVD)
The molecule that activates synthesized rFC
The net charge of endotoxin
What is negative
A substance consisting of glucose molecules with beta-D-glucosidic linkages
What are glucans
The particles that aggregate to form a turbid solution
What are coagulin particles
Another substance that can initiate the LAL reaction
What are beta-glucans
The only enzyme present in the rFC assay
A factor which may influence the aggregation state of endotoxin
What is (temperature, pH, salts (particularly divalent cations), surfactants, bile salts, and proteins)
Fungi, plant tissue, certain algae, and bacteria
What are common sources of beta-glucans
The sensitivity of the LAL reagent to glucan in comparison to endotoxin on a mass basis
What is 10-fold less
A critical parameter in the LAL reaction
What is pH
The substance that is analogous to the chromogen in the chromogenic reagent
What is fluorogen
Substances from plastics that can interfere with the endotoxins test
What are extractables
A buffer used to render the LAL test specific to endotoxin
What is a glucan blocking buffer
The approximate equivalency of one endotoxin unit
What is 0.1 ng of E. coli endotoxin or 0.1 parts per billion
The type of ion commonly included in LAL reagent formulations
Divalent cations
The incubation time for the rFC assay
What is one hour
The type of plastic known to be highly inhibitory in the endotoxin test
What is polypropylene
A potential source of glucan contamination in manufacturing or the lab
What is cardboard
The wavelength the pNA chromophore absorbs light at
What is 405 nm
The specific wavelength at which absorption maximum occurs with the kinetic turbidimetric method
What is there is no specific wavelength
The name of the Asian horseshoe crab from which its genetic material was used to produce rFC
What is Carcinoscorpius rotundicauda
A substance which has been shown to recover the activity of endotoxin which has aggregated
What is triethylamine (TEA)
Processes that should be evaluated for their likelihood of contributing beta-glucans
What are the manufacturing and testing processes