New FDA Guideline on Quality of Heparin

Recommendation

13-15 May 2025
Vienna, Austria

Analytical Instrument Qualification
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

In June 2013, the FDA published the final Guideline on "Crude Heparin" Quality. This guidance is intended to alert to the potential risk of crude (= unprocessed) heparin contamination.

The tests listed in the guideline intend to help avoiding the use of oversulfated chondroitin sulfate (OSCS). OSCS was the impurity identified in 2008 which appeared to have been intentionally mixed to heparin to reduce the cost of production. In the past, this OSCS mixture had caused the death of patients undergoing dialysis.

Furthermore, the identification and the control of animals' origin have to be ensured. Crude heparin is primarily sourced from porcine mucosa and not from bovine ones (ruminants) because of the higher risk of contamination with the BSE. The control of the animal origin is thus crucial.

In the guideline, the FDA recommends the use of a PCR method to confirm that crude heparin is of porcine sources. It is recommended to use a SAX HPLC method to exclude the presence of OSCS.

Click here to access the complete FDA Guideline.