Anticoagulant Citrate Phosphate Dextrose Solution
» Anticoagulant Citrate Phosphate Dextrose Solution is a sterile solution of Citric Acid, Sodium Citrate, Monobasic Sodium Phosphate, and Dextrose in Water for Injection. It contains, in each 1000 mL, not less than 2.11 g and not more than 2.33 g of monobasic sodium phosphate (NaH2PO4·H2O); not less than 24.22 g and not more than 26.78 g of dextrose (C6H12O6·H2O); not less than 19.16 g and not more than 21.18 g of total citrate, expressed as citric acid, anhydrous (C6H8O7); and not less than 6.21 g and not more than 6.86 g of Sodium (Na). It contains no antimicrobial agents.
Prepare Anticoagulant Citrate Phosphate Dextrose Solution as follows:
Dissolve the ingredients, and mix. Filter the solution until clear, place immediately in suitable containers, and sterilize.
If desired, 3.27 g of monohydrated citric acid may be used instead of the indicated amount of anhydrous citric acid; 23.06 g of anhydrous sodium citrate may be used instead of the indicated amount of dihydrated sodium citrate; 1.93 g of anhydrous monobasic sodium phosphate may be used instead of the indicated amount of monohydrated monobasic sodium phosphate; and 23.2 g of anhydrous dextrose may be used instead of the indicated amount of monohydrated dextrose.
Packaging and storage Preserve in single-dose containers, of colorless, transparent, Type I or Type II glass, or of a suitable plastic material (see Transfusion and Infusion Assemblies and Similar Medical Devices 161).
Labeling Label it to indicate the number of mL of Solution required per 100 mL of whole blood or the number of mL of Solution required per volume of whole blood to be collected.
USP Reference standards 11
USP Endotoxin RS
Identification It responds to the Identification test under Dextrose, and to the tests for Phosphate 191, and, when concentrated to one-half its volume, responds to the tests for Citrate 191 and for Sodium 191.
Bacterial endotoxins 85 It contains not more than 5.56 USP Endotoxin Units per mL.
pH 791: between 5.0 and 6.0.
Chloride 221 A 10-mL portion shows no more chloride than corresponds to 0.50 mL of 0.020 N hydrochloric acid (0.0035%).
Other requirements It meets the requirements under Injections 1.
Assay for total citrate and total phosphate
Mobile Phase, Standard Preparation 2, and Chromatographic System Proceed as directed under Assay for Citric Acid/Citrate and Phosphate 345.
Assay preparation for total citrate assay 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.
Assay preparation for total phosphate assay Pipet 5 mL of Solution into a suitable volumetric flask, and proceed as directed for Assay Preparation for Phosphate Assay under general chapter 345.
Procedure Proceed as directed for Procedure under general chapter 345, and calculate the quantity, in mg, of anhydrous citric acid (C6H8O7) in the volume of Solution taken by the formula:
0.001(192.12/189.10)CS D(rU / rS)in which 192.12 is the molecular weight of anhydrous citric acid; 189.10 is the molecular weight of citrate (C6H5O7); CS is the concentration, in µg per mL, of citrate in Standard Preparation 2; D is the dilution factor; and rU and rS are the citrate peak areas obtained from the Assay preparation for total citrate assay and Standard Preparation 2, respectively.
Calculate the quantity, in mg, of phosphate, expressed as monobasic sodium phosphate monohydrate (NaH2PO4·H2O), in the volume of Solution taken by the formula:
0.001(137.99/94.97)CS D(rU / rS)
in which 137.99 is the molecular weight of monobasic sodium phosphate monohydrate; 94.97 is the molecular weight of phosphate (PO4); CS is the concentration, in µg per mL, of phosphate in Standard Preparation 2; D is the dilution factor; and rU and rS are the phosphate peak areas obtained from the Assay preparation for total phosphate assay and Standard Preparation 2, respectively.
Assay for dextrose Tare a clean, medium-porosity filtering crucible containing several carborundum boiling chips or glass beads. Pipet 50 mL of freshly mixed alkaline cupric tartrate TS into a 400-mL beaker. Add the boiling chips or glass beads from the tared crucible, 45 mL of water, and 5.0 mL of Solution to the beaker. Heat the beaker and contents over a burner that has been adjusted to cause boiling of the solution to start in 3.5 to 4 minutes. Boil the solution for 2 minutes, accurately timed, and filter immediately through the tared crucible, taking care to transfer all of the boiling chips or glass beads to the crucible. Wash the precipitate with hot water and 10 mL of alcohol. Dry the crucible and contents at 110 to constant weight. Perform a blank determination, and correct the weight of the precipitate from the sample for any precipitate obtained in the blank. Each mg of cuprous oxide precipitate obtained from the substance under assay is equivalent to 0.496 mg of C6H12O6·H2O.
Assay for sodium Proceed as directed in the Assay for sodium under Anticoagulant Citrate Phosphate Dextrose Adenine Solution.
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USP35NF30 Page 2226Pharmacopeial Forum: Volume No. 31(3) Page 730