OEM/ODM China Kinetic Turbidimetric Method of endotoxin testing - Kinetic Turbidimetric Amebocyte Lysate Vial – Bioendo
OEM/ODM China Kinetic Turbidimetric Method of endotoxin testing - Kinetic Turbidimetric Amebocyte Lysate Vial – Bioendo Detail:
Kinetic Turbidimetric Amebocyte Lysate Vial
1. Product Introduction
Kinetic Turbidimetric Amebocyte Lysate Vial is developed based on the principle that the time needed to reach a certain absorbance increase (onset OD), i.e. onset time, is negatively correlated with the endotoxin concentration. Sensitivity could reach 0.005EU/ml, and the detection could reach four orders of magnitude. It is specially suitable for pharmaceuticals industry to monitor endotoxin concentration.
2. Product Parameter:
Assay range:0.005-50EU/ml; 0.01 – 10EU/ml
3. Product Application
End-product endotoxin (pyrogen) qualification, Water for injection endotoxin assay, raw material endotoxin testing or endotoxin level monitoring during manufacturing process for pharmaceutical companies or medical devices manufacturers.
Note:
Lyophilized Amebocyte Lysate reagent manufactured by Bioendo is made from amebocyte lysate from the horseshoe crab (Tachypleus tridentatus).
|
Catalog No. |
ml/vial |
Tests/Vial |
Vials/Pack |
Sensitivity EU/ml |
|
KT17 |
1.7 |
16 |
10 |
0.01-10EU/ml |
|
KT17S |
1.7 |
16 |
10 |
0.005-5EU/ml, 0.01-10EU/ml |
|
KT52 |
5.2 |
50 |
10 |
0.01-10EU/ml |
|
KT52S |
5.2 |
50 |
10 |
0.005-5EU/ml, 0.01-10EU/ml |
The Lyophilized Amebocyte Lysate reagent sensitivity and the Control Standard Endotoxin potency are assayedagainst USP Reference Standard Endotoxin. The Lyophilized Amebocyte Lysate reagent kits come withproduct instruction, Certificate of Analysis.


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