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Food and Drug Regulations

Version of section C.04.415 from 2006-03-22 to 2006-12-13:


 A pyrogen-free anticoagulant solution shall be used in every plasmapheresis program consisting of one of the following formulae:

  • (a) Anticoagulant acid citrate dextrose solution (ACD)

    Trisodium citrate (Na3C6H5O7.2H2O)blank line22.0 g

    Citric acid (C6H8O7.H2O)blank line8.0 g

    Dextrose (C6H12O6H2O)blank line24.5 g

    Water for Injection (U.S.P.) to makeblank line1 000.0 mL

  • (b) Anticoagulant citrate phosphate dextrose solution (CPD)

    Trisodium citrate (Na3C6H5O7.2H2O)blank line26.3 g

    Citric acid (C6H8O7.H2O)blank line3.3 g

    Dextrose (C6H12O6H2O)blank line25.5 g

    Monobasic sodium phosphate (NaH2PO4H2O)blank line2.2 g

    Water for Injection (U.S.P.) to makeblank line1 000.0 mL

  • (c) Anticoagulant citrate phosphate dextrose adenine solution (CPDA-I)

    Trisodium citrate (Na3C6H5O7.2H2O)blank line26.3 g

    Citric acid (C6H8O7.H2O)blank line3.3 g

    Dextrose (C6H12O6H2O)blank line31.9 g

    Monobasic sodium phosphate (NaH2PO4H2O)blank line2.2 g

    Adenine (C5H5N5)blank line275.0 mg

    Water for Injection (U.S.P.) to makeblank line1 000.0 mL

  • (d) Anticoagulant sodium citrate solution (SC)

    Trisodium citrate (Na3C6H5O7.2H2O)blank line40.0 g

    Water for Injection (U.S.P.) to makeblank line1 000.0 mL

  •  SOR/78-545, s. 1
  • SOR/85-1022, s. 6
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