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.

USP Reference standards 11 —

USP Citric Acid RS .
USP Endotoxin RS.
(Official April 1, 2009)
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)
Auxiliary Information— Please check for your question in the FAQs before
contacting USP.
Topic/Question Contact Expert Committee
Monograph Anita Y. Szajek, Ph.D. (BBBBP05) Biologics and Biotechnology -
Senior Scientist Blood and Blood Products
1-301-816-8325
Reference Lili Wang, Technical
Standards Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, (MSA05) Microbiology and Sterility
Ph.D. Assurance
Senior Scientist
1-301-816-8339
USP32–NF27 Page 1567
Pharmacopeial Forum: Volume No. 31(3) Page 731

The formulas of the active ingredients are provided in Table 1.

Table 1: Active Ingredients

Ingredients Molecular Formula Molecular Weight

Sodium Citrate Dihydrate C6H9Na3O9 294.10

Water for Injection H2O 18.00

Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP

contains: Sodium Citrate (dihydrate) 4.0 g; and 100mL Water for Injection (pH
adjusted with citric acid).
The PVC bag is not made with natural rubber latex.