U.S. PHARMACOPEIA

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Anticoagulant Sodium Citrate Solution
» Anticoagulant Sodium Citrate Solution is a sterile solution of Sodium Citrate in Water for Injection. It contains, in each 100 mL, not less than 3.80 g and not more than 4.20 g of C6H5Na3O7·2H2O. It contains no antimicrobial agents.
Sodium Citrate (dihydrate) 40 g
Water for Injection, a sufficient
quantity to make
1000 mL
NOTE—Anhydrous sodium citrate (35.1 g) may be used instead of the dihydrate.
Dissolve the Sodium Citrate in sufficient Water for Injection to make 1000 mL, and filter until clear. Place the solution in suitable containers, and sterilize.
Packaging and storage— Preserve in single-dose containers, preferably of Type I or Type II glass.
Identification— When evaporated to a concentration of 1 in 20, it responds to the tests for Sodium 191 and for Citrate 191.
Bacterial endotoxins 85— It contains not more than 5.56 USP Endotoxin Units per mL.
pH 791: between 6.4 and 7.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer 10.0 mL of Solution to a 250-mL beaker, and evaporate to dryness. Add 100 mL of glacial acetic acid, stir until completely dissolved, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically using a calomel-glass electrode system. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 9.803 mg of C6H5Na3O7·2H2O.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (BBBBP05) Biologics and Biotechnology - Blood and Blood Products
USP29–NF24 Page 183
Pharmacopeial Forum : Volume No. 31(3) Page 731
Phone Number : 1-301-816-8305