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.
[noteAnhydrous 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 Endotoxin RS
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.
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.
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USP35NF30 Page 2228Pharmacopeial Forum: Volume No. 31(3) Page 731