After the European Pharmacopoeia (EP) already took steps towards including the recombinant Factor C (rFC) test as a compendial assay, the United States Pharmacopeia (USP) is now following suit. On 3 September 2019, the US Pharmacopeial Forum published a draft for a revised Chapter <85> that would include recombinant reagents. Unlike the EP, whose draft was for a completely new “rFC chapter” 2.6.32, the USP chose to propose an adaptation of the existing chapter on Bacterial Endotoxin Testing.
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USP Chapter 85 including rFC - Draft for Comment Released