Food and Drug Regulations

C.04.415 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)22.0 g

  Citric acid (C₆H₈O₇.H₂O)8.0 g

  Dextrose (C₆H₁₂O₆H₂O)24.5 g

  Water for Injection (U.S.P.) to make1 000.0 mL

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

  Trisodium citrate (Na₃C₆H₅O₇.2H₂O)26.3 g

  Citric acid (C₆H₈O₇.H₂O)3.3 g

  Dextrose (C₆H₁₂O₆H₂O)25.5 g

  Monobasic sodium phosphate (NaH₂PO₄H₂O)2.2 g

  Water for Injection (U.S.P.) to make1 000.0 mL

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

  Trisodium citrate (Na₃C₆H₅O₇.2H₂O)26.3 g

  Citric acid (C₆H₈O₇.H₂O)3.3 g

  Dextrose (C₆H₁₂O₆H₂O)31.9 g

  Monobasic sodium phosphate (NaH₂PO₄H₂O)2.2 g

  Adenine (C₅H₅N₅)275.0 mg

  Water for Injection (U.S.P.) to make1 000.0 mL

• (d) Anticoagulant sodium citrate solution (SC)

  Trisodium citrate (Na₃C₆H₅O₇.2H₂O)40.0 g

  Water for Injection (U.S.P.) to make1 000.0 mL