English
We supply kinetic turbidimetric LAL lysate for pharmaceutical and medical device industries for testing the endotoxin level of the injectable drugs and implantable medical devices at China. In the past 35 years, we devoted ourselves to the research of LAL endotoxin testing technology, to make sure the quality of drug products and medical devices, allows the monitoring of the endotoxin level during production process.
1. Product introduction
The kinetic LAL assay a simple measurement for endotoxin quantification. Based on the principle that in the presence of endotoxin LAL becomes turbid, the increase rate of turbidity is proportional to the endotoxin concentration of the sample, the endotoxin is quantified. 1.The detection limit for the assay kit is 0.005EU/ml and the detection range is up to four orders of magnitude. Using kinetic microplate reader Elx808IULALXH and TALgent software, kinetic turbidimetric assay automatic quantify endotoxins in a single step for 96 tests at a time. 2.The test efficiency could be improved dramatically with the help of multi-channel pipettor or automatic sample processing device. 3.Kinetic turbidimetric assay is applicable to the pharmaceutical industry endotoxin monitoring in the manufacturing process, including raw materials, water for injection, intermediate products and end products endotoxin tests. 4.We provide kinetic turbidimetric LAL reagent in 0.5ml, 1.7ml, 2.2ml and 5.2ml per vials. The reagent is recommended to use for Water for Injection endotoxin testing. LAL endotoxin assay kits include control standard endotoxin, LAL reagent water, pyrogen-free pipettor tips, glass test tube for endotoxin dilution is also available.
2. Product parameter
Assay range: 0.005-50EU/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.
Operation chart
Standard curve
4. Order information
ml/vial | Tests/vial | Vials/pack | |
KT05 | 0.5 | 4 | 10 |
KT17 | 1.7 | 15 | |
KT22 | 2.2 | 20 | |
KT28 | 2.8 | 26 | |
KT52 | 5.2 | 50 |
5. Ordering FAQ
Product condition: The LAL reagent sensitivity and the Control Standard Endotoxin potency are assayed against USP Reference Standard Endotoxin. The LAL reagent kits come with product instruction, Certificate of Analysis, MSDS.