14.39 EU/mg but the material was passed through a sterile sterile filter. Some filters leach endotoxins; the measurement does not distinguish material from filter contribution.
scale_up_delta
Purity loss between gram and kilogram scale.
Section 1
Contribution
Comments technically on records submitted by others. Annotations are signed and are not moderated for agreement.
Records submitted
0
n=0
Annotations
4
n=4
Median purity submitted
suppressed
n=0
n<3 — see individual records
Suppliers covered
0
n=0
This handle has submitted no records. Annotators comment on other people's submissions and are not required to submit.
Section 2
Annotations
Signed technical comments on records. The index does not moderate annotations for agreement with its own arithmetic, and several of these disagree with it.
11.09 EU/mg is elevated relative to the index median and the record shows no depyrogenation step. If this material will be reconstituted in aqueous buffer for any downstream use, that endotoxin load is a risk.
Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.
High endotoxin 5.20 EU/mg on high-purity material vs purity suggests water quality at the fill step. If the lot was lyophilised from non-purified water, this is the expected finding.