Anticoagulant Sodium Citrate Solution
»Anticoagulant Sodium Citrate Solution is a sterile solution of Sodium Citrate in Water for Injection.It contains,in each 100mL,not less than 3.80g and not more than 4.20g of C6H5Na3O7·2H2O.It contains no antimicrobial agents.
Sodium Citrate (dihydrate) 40g
Water for Injection,a sufficient
quantity to make
1000mL
NOTE—Anhydrous sodium citrate (35.1g)may be used instead of the dihydrate.
Dissolve the Sodium Citrate in sufficient Water for Injection to make 1000mL,and filter until clear.Place the solution in suitable containers,and sterilize.
Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass.
Identification— When evaporated to a concentration of 1in 20,it responds to the tests for Sodium á191ñand for Citrate á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 5.56USP Endotoxin Units per mL.
pHá791ñ: between 6.4and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer 10.0mLof Solution to a 250-mLbeaker,and evaporate to dryness.Add 100mLof glacial acetic acid,stir until completely dissolved,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically using a calomel-glass electrode system.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 9.803mg of C6H5Na3O7·2H2O.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 168
Phone Number:1-301-816-8339