Analysis of endotoxins: rFC test provides safety for producers of pharmaceuticals
Sterile pharmaceuticals and sterile medical products need to be tested to make sure that they are free of endotoxin in order to rule out bacterial contamination. These include highly invasive pharmaceuticals, such as infusion solutions or excipients such as water for injection (WFI). In addition, non-sterile bulk goods or in-process controls can also be tested for endotoxins. In addition to the proven LAL test (limulus amoebocyte lysate test), WESSLING now provides producers of pharmaceuticals with the rFC test (recombinant factor C test). This rFC test is a proven alternative method which will also be included in the regulations of the European Pharmacopoeia from 1 January 2021 (according to Ph. Eur. 2.6.32).
Advantages of the rFC test
1. Speed
2. High quality
- Implementation in Ph. Eur. 2.6.32 from 01 January 2021
- Successful internal method validation
- Customised, product-specific suitability test
3. High performance compared to the LAL test:
- 5 times higher sensitivity (0.005 EU/mL)
- Increased accuracy: no false positive results from ß-glucans, e.g., in sterile filtered samples
- Precise determination, including samples with high endotoxin content (range from 0.005 - 50 EU/mL)
- High lot-to-lot consistency due to standardize production
- Sustainable and resource-saving alternative method to the LAL test
You have questions or would like to order the rFC test at WESSLING?
Please do not hesitate to contact me.
- Dr. Maik Siebelmann
- +49 251 13 39 880
- pharma@wessling.de
