Bacterial Endotoxin Detection Testing Assay has several methods such as Gel Clot Assay, Kinetic Turbidimetric Assay and Kinetic Chromogenic Assay. Now the new Alternative Method is coming, this method is Recombinant Factor C (rFC) Assay. rFC method use chemical synthetic substate from horseshoe crab blood.

In January 2019, European Pharmacopeia (EP) assigns Recombinant Factor C (rFC) Method to EP <2.6.32>. In September 2019, the United States Pharmacopeia (USP) assigns to Alternatve Method in Pharmacopeial Guidelines USP <85>. Japanese Pharmacopeia (JP) publishs JP <4.01> Bacterial Endotoxin Testing by use Recombinant Protein-Reagent and Chinese Pharmacopeia (CP) publishs rFC Method is Alternatve Method too.

On the information above indicate that Recombinant Factor C (rFC) method is new trending in Pharmaceutical and Biomedical Industries.

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