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.
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.
(Official until April 1, 2009)
Assay—
Mobile Phase, Standard Preparation 1, and Chromatographic System— Proceed as directed under Assay for Citric Acid/Citrate and Phosphate 345.
Assay preparation— Pipet 10 mL of Solution into a suitable volumetric flask, and proceed as directed for Assay Preparation for Citric Acid/Citrate Assay under general chapter 345.
Procedure— Proceed as directed for Procedure under general chapter 345, and calculate the quantity, in mg, of sodium citrate dihydrate (C6H5Na3O7·2H2O) in the volume of Solution taken by the formula:
0.001(294.10/189.10)CS D(rU / rS)
in which 294.10 is the molecular weight of sodium citrate dihydrate; 189.10 is the molecular weight of citrate (C6H5O7); CS is the concentration, in µg per mL, of citrate in Standard Preparation 1; D is the dilution factor; and rU and rS are the citrate peak areas obtained from the Assay preparation and Standard Preparation 1, respectively.
(Official April 1, 2009)
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Topic/Question Contact Expert Committee
Monograph Anita Y. Szajek, Ph.D.
Senior Scientist
1-301-816-8325		 (BBBBP05) Biologics and Biotechnology - Blood and Blood Products
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1567
Pharmacopeial Forum: Volume No. 31(3) Page 731