Will the High Costs of Analytics Permit Future Cases of Heparin Contamination?

Nov. 25, 2008

Any crime covered by the press inspires a wave of copycats.  So, it seems, the global heparin supply chain will have to be closely monitored for some time.  Both 2-D NMR and capillary electrophoresis have been recognized as the best ways to assess the purity of heparin. Both are beautiful techniques, and yield a lot of information, but they also require highly experienced analysts and expensive equipment. 

Any crime covered by the press inspires a wave of copycats.  So, it seems, the global heparin supply chain will have to be closely monitored for some time.  Both 2-D NMR and capillary electrophoresis have been recognized as the best ways to assess the purity of heparin. Both are beautiful techniques, and yield a lot of information, but they also require highly experienced analysts and expensive equipment. 

Which begs the question: aren't there less expensive options?

Heard recently that both NIR and Raman spectroscopy were effective in identifying contaminant peaks.

They may not provide all the information that the USP-recommended techniques offer, but could their use be enough to allow manufacturers to determine whether material at their facilities contained the contaminant du jour?

Given financial conditions today and tightened budgets, particularly for generic drug suppliers, wouldn't it make sense to issue additional testing procedures and guidance for using more down-to-earth analytical technologies that more companies could actually afford?  

AMS

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