BIOIBERICA's heparin sodium fully complies with the new USP monograph revision USP 37 NF32
Bioiberica whises to inform its customers that its heparin sodium is fully compliant with the new requirements established by the Heparin Sodium USP monograph revision that is effective in USP 37 NF32, on May 1st, 2014.
The main variations introduced by the new Monograph are changes to 5 assays, the inclusion of a molecular weight analysis and the requirement to validate the heparin manufacturing process with studies on lipid clearance. During a period of 6 months Bioiberica has been adapting the testings, implementing and validating the new ones. Bioibérica also validated the ability of the process to remove the lipid content significantly. As a consequence of that, since May 1st, 2014 Bioiberica is certifying its sodium heparin according to the new criteria.
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- Bioiberica produces 20% of the world's Heparin API.
- Heparin saves around a hundred million lives every year.
- One out of every 5 doses of heparin administered in the world comes from Bioiberica.