Anticoagulant Citrate Dextrose Solution
»Anticoagulant Citrate Dextrose Solution is a sterile solution of Citric Acid,Sodium Citrate,and Dextrose in Water for Injection.It contains in each 1000mL:
| Solution A |
Solution B |
|
| Total Citrate,expressed as citric acid,anhydrous (C6H8O7) |
||
| not less than | 20.59g | 12.37g |
| not more than | 22.75g | 13.67g |
| Dextrose (C6H12O6·H2O) | ||
| not less than | 23.28g | 13.96g |
| not more than | 25.73g | 15.44g |
| Sodium (Na) | ||
| not less than | 4.90g | 2.94g |
| not more than | 5.42g | 3.25g |
It contains no antimicrobial agents.
Prepare Anticoagulant Citrate Dextrose Solution as follows:
| Solution A |
Solution B |
|
| Citric Acid (anhydrous) | 7.3g | 4.4g |
| Sodium Citrate (dihydrate) | 22.0g | 13.2g |
| Dextrose (monohydrate) | 24.5g | 14.7g |
| Water for Injection,a sufficient quantity,to make |
1000mL | 1000mL |
Dissolve the ingredients,and mix.Filter the solution until clear,place immediately in suitable containers,and sterilize.
If desired,8g and 4.8g of monohydrated citric acid may be used instead of the indicated,respective amounts of anhydrous citric acid;19.3g and 11.6g of anhydrous sodium citrate may be used instead of the indicated,respective amounts of dihydrated sodium citrate;and 22.3g and 13.4g of anhydrous dextrose may be used instead of the indicated,respective amounts of monohydrated dextrose.
Packaging and storage—
Preserve in single-dose containers,of colorless,transparent,Type Ior Type IIglass,or of a suitable plastic material (see Transfusion and Infusion Assemblies and Similar Medical Devices á161ñ).
Labeling—
Label it to indicate the number of mLof Solution required per 100mLof whole blood or the number of mLof Solution required per volume of whole blood to be collected.
Identification—
It responds to the Identificationtest under Dextrose,and,when concentrated to one-half its volume,responds to the tests for Citrate á191ñand for Sodium á191ñ.
Bacterial endotoxins á85ñ—
It contains not more than 5.56USP Endotoxin Units per mL.
pHá791ñ:
between 4.5and 5.5.
Chloride á221ñ—
A10-mLportion shows no more chloride than corresponds to 0.50mLof 0.020Nhydrochloric acid (0.0035%).
Other requirements—
It meets the requirements under Injections á1ñ.
Assay for total citrate—
Proceed as directed in the Assay for total citrateunder Anticoagulant Citrate Phosphate Dextrose Solution.Report total citrate per Lof sample (as citric acid,anhydrous).
Assay for sodium—
Proceed as directed in the Assay for sodiumunder Anticoagulant Citrate Phosphate Dextrose Adenine Solution.
Assay for dextrose—
Determine the angular rotation of Solution in a 200-mm tube,using sodium light at 25
.The observed rotation in degrees,multiplied by 1.0425,represents the weight of C6H12O6·H2Oin 100mLof the solution.
.The observed rotation in degrees,multiplied by 1.0425,represents the weight of C6H12O6·H2Oin 100mLof the solution.
Auxiliary Information—
Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 165
Pharmacopeial Forum:Volume No.30(5)Page 1583
Phone Number:1-301-816-8339