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U.S. Department of Health and Human Services

Drugs

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Documentation Required for importing low molecular weight heparin (LMW) products

The analytical file must include data for the heparin sodium API used to make the LMWH API. If possible, data should be submitted in one electronic files are requested to submit the following analytical data with each shipment:

  • (1)H-NMR spectrum (testing conducted per current USP method) expanded 1.8 to 3.0 ppm region shown
  • HPLC-SAX chromatogram (testing conducted per USP method)
  • When testing is not conducted per USP, the firm must provide one additional at the standard chromatogram that has been spiked with OSCS and analyzed same time as the current test lot.
  • Certificate of Analysis for the LMWH API batch. This document should include certification that no OSCS is present in the drug.