Determination of bacterial endotoxins using rFC tests
The demand for endotoxin determination using recombinant test systems (rFC test) in the field of pharmaceutical analysis continues to increase. WESSLING has been offering this rFC test to its customers as part of routine analysis for some time now; it is therefore an integral part of the analytical portfolio of our pharmaceutical specialists.
Endotoxins are components of the outer cell membrane of Gram-negative bacteria. They can cause inflammation and other physiological reactions in the human body. Sterile drugs and sterile medical devices must therefore be strictly checked to ensure that they are free of endotoxins. This is the only way to ensure that they do not contain bacterial contamination and that the products are safe.
Sterile drugs and sterile medical devices to be reviewed include:
- highly invasive drugs such as infusion solutions,
- drug excipients such as water for injection (WFI) or
- non-sterile bulk products
Proven alternative method to the LAL test
The rFC test (recombinant factor C test) is a tested alternative method to the LAL test, which has now also been included in the regulations of the European Pharmacopoeia (according to Ph. Eur. 2.6.32). Quantification is based on highly sensitive fluorescence detection. The response of the rFC assay is less susceptible to interference compared to an LAL assay.
These are the other advantages of an rFC test over an LAL test:
- 5-fold higher sensitivity (0.005 EU/mL)
- Increased specificity: no false positive results due to ß-glucans, e.g., in sterile-filtered samples
- Precise determination even of samples with high endotoxin content (range from 0.005 - 50 EU/mL)
- High lot-to-lot consistency due to standardised manufacture
Sustainable and resource-saving test method
In addition, the rFC test protects the endangered population of horseshoe crabs, from whose blood the lysate for the classic LAL test was previously obtained.
Your contact to our pharmaceutical specialists
- Dr. Maik Siebelmann
- +49 251 13 39 880
- pharma@wessling.de
