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Frequently Asked Questions: Endotoxin Detection & Removal


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Frequently Asked Questions: Endotoxin Detection & Removal

1. Which endotoxin detection kit should we use?
2. What pH should we set the sample at?
3. Why is it important to vortex standard endotoxin solution?
4. Is the sample storage and handling important?
5. Can finished drug samples for analysis of bacterial endotoxins be pooled into a composite sample prior to analysis?
6. What about Endotoxin Removal Kit?


1. Which endotoxin detection kit should we use?

Creative Biogene offers two kits which accurately detect the amount of endotoxin in a protein. Compared to other high-throughput quantitation kits, these quantitation kits are ideal for processing a few samples at a time.

Chromogenic LAL Endotoxin Assay Kit is used to in vitro end-point endotoxin quantitative test of animal and human parenteral drugs, biological products, and medical devices. The detecting concentrations of Kit range from 0.01 - 1 EU/ml.

Gel Clot Endotoxin Assay Kit is designed as a simple and sensitive in vitro end-product endotoxin test for animal and human parenteral drugs, biological products, and medical devices. Moreover, the sensitivity of LAL in this kit is 0.25 EU/ml.

2. What pH should we set the sample at?

In order to ensure good linearity, the pH of the sample should be at pH 6-8.

3. Why is it important to vortex standard endotoxin solution?

Endotoxin can adhere to the surface of glassware, but this problem can be mediated through the vortex. The endotoxin standard solution should be vigorously vortexed for 15 minutes before making dilutions, and repeat the vortex step each time prior to making dilutions, not just after reconstitution.

4. Is the sample storage and handling important?

Yes. The ability to detect endotoxins could be affected by storage and handling. We have established procedures for storing and handling samples for bacterial endotoxins analysis by laboratory data that demonstrate the stability of assayable endotoxins content.

5. Can finished drug samples for analysis of bacterial endotoxins be pooled into a composite sample before analysis?

Yes. With some exceptions, finished drug product units can be pooled into a composite sample and assayed for bacterial endotoxins. The composite sample may be represented by the entire unit or partial aliquots of finished product containers from one manufactured lot of aqueous-based pharmaceuticals.

6. What about Endotoxin Removal Kit?

Our Endotoxin Removal Kit is an efficient endotoxin removal tool. The final endotoxin level can be reduced under 0.1 EU/ml with repeated use of Easy™ Endotoxin Removal resin. The kit can be used to remove endotoxin from proteins, antibodies, peptides, or even DNA samples.

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