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U.S. Department of Health and Human Services

Drugs

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Documentation Required for Importing Heparin Sodium API and finished dosage forms

All Heparin Sodium API and finished dosage form heparin sodium entries are required to submit analytical data.

Firms are requested to submit the following analytical data with each shipment:

  • Certificate of Analysis for the batch
  • (1)H-NMR spectrum (testing conducted per current USP method), with 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 standard chromatogram that has been spiked with oversulfated chondroitin sulfate (OSCS) and analyzed at the same time as the current test lot.