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[Biological and HPLC analysis of heparin after thermal treatment]
A Pintabona1, A Bottazzi, R Capra
1Controllo Qualità Schwarz Pharma s.p.a., S. Grato, Lodi.
Abstract:
Heparin solutions ampoules have been autoclaved at 105 degrees C-110 degrees C-121 degrees C-134 degrees C for 15 minutes. The biological activity has not decreased after the treatment, but a reduction was observed after a storage period of 36 months at room temperature for sterilizing treatments. Analysis of heparin by size exclusion and reversed phase HPLC with the method developed in our laboratories allowed us to demonstrate a substantial stability of the molecular structure. These methods showed to be suitable for a qualitative evaluation of the heparin itself.