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  5. Documentation Required for Importing Crude Heparin
  1. Guidance, Compliance, & Regulatory Information

Documentation Required for Importing Crude Heparin

Documentation Required for Importing Crude Heparin

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

  • SAX-HPLC chromatograms
  • The 500 MHz 1D-1H-NMR spectrum , which includes an expansion plot of the1.8 to 2.3 ppm region along with the full spectrum.
  • The test methods for HPLC-SAX and NMR mentioned above are describe the following manuscript: J. Pharm. Biomed. Anal. 51 (2010) 921-926

This test method can also be referenced on FDA’s website at the following link: http://www.fda.gov/aboutfda/centersoffices/cder/ucm136991.htm