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18 July 2013

Heparin sodium BRP batch 3 for chromogenic assays

An international collaborative study coordinated by the EDQM for the Biological Standardisation Programme (BSP) has defined a new assigned value for the current Heparin sodium BRP batch 3 (cat. ref.: H0200000) to allow its use in the chromogenic assays for anti-IIa and anti-Xa activities. These two chromogenic methods are currently being considered by the Ph. Eur. Group of Experts on Biologicals as replacements for the current clotting assay in the Ph. Eur. general text 2.7.5.

The Heparin sodium BRP has been assigned 2 potency values - i.e., 1 for the clotting assay and 1 for the chromogenic assays – for the period until the general text 2.7.5. is revised.

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