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. Author manuscript; available in PMC: 2019 May 14.
Published in final edited form as: Nat Biotechnol. 2016 Jun 9;34(6):625–630. doi: 10.1038/nbt.3606

Figure 1.

Figure 1

Heparin crisis and resolution timeline. After the contamination crisis, the USP undertook and concluded a three-stage set of revisions to the Heparin Sodium monograph. Stage 1 involved the initial addition of identity tests and introduction of reference standards to prevent contaminated heparins from entering the US market. Stage 2 strengthened the entire monograph by including specific potency testing, additional tests and tightening existing limits for impurities. Stage 3 focused on further tightening limits for impurities and controlling heparin’s polydispersity by molecular weight analysis.