Anticoagulant Heparin Solution
»Anticoagulant Heparin Solution is a sterile solution of Heparin Sodium in Sodium Chloride Injection.Its potency is not less than 90.0percent and not more than 110.0percent of the potency stated on the label in terms of USP Heparin Units.It contains not less than 0.85percent and not more than 0.95percent of sodium chloride (NaCl).It may be buffered.It contains no antimicrobial agents.
Heparin Sodium 75,000Units
Sodium Chloride Injection,a
sufficient quantity to make
1000mL
Add the Heparin Sodium,in solid form or in solution,to the Sodium Chloride Injection,mix,filter if necessary,and sterilize.
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 in terms of USP Heparin Units,and to indicate the number of mLof Solution required per 100mLof whole blood.
Bacterial endotoxins á85ñ— It contains not more than 2.5USP Endotoxin Units per mL.
pHá791ñ: between 5.0and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for heparin sodium— Proceed as directed in the Assayunder Heparin Sodium Injection,substituting Anticoagulant Heparin Solution for the Injection.
Assay for sodium chloride— Pipet 10mLof Solution into a suitable container,add 2mLof potassium chromate TS,and titrate with 0.1Nsilver nitrate VS.Each mLof 0.1Nsilver nitrate is equivalent to 5.844mg of NaCl.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 168
Phone Number:1-301-816-8339