Packaging and storage— Preserve in single-dose prefilled syringes or containers,or in multiple-dose containers,preferably of Type Iglass.

Labeling— Label it to indicate the volume of the total contents,and to indicate the potency in terms of USP Heparin Units only per mL,except that single unit-dose containers may be labeled additionally to indicate the single unit-dose volume and the total number of USP Heparin Units in the contents.Where it is labeled with total content,the label states clearly that the entire contents are to be used or,if not,any remaining portion is to be discarded.Label it to indicate the organ and species from which the heparin sodium is derived.The label states also that the Solution is intended for maintenance of patency of intravenous injection devices only,and that it is not to be used for anticoagulant therapy.The label states also that in the case of Solution having a concentration of 10USP Heparin Units per mL,it may alter,and that in the case of higher concentrations it will alter,the results of blood coagulation tests.

USP Reference standards á11ñ— USP Heparin Sodium RS.USP Endotoxin RS.

Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.

pHá791ñ: between 5.0and 7.5.

Particulate matter á788ñ: meets the requirements for small-volume injections.

Other requirements— It meets the requirements under Injections á1ñ.

Assay for heparin sodium— Proceed as directed in the Assayunder Heparin Sodium Injection,substituting Heparin Lock Flush Solution for the Injection.

Assay for sodium chloride— Pipet 10mLof Solution into a suitable container,dilute with water to about 150mL,add 1.5mLof potassium chromate TS,and titrate with 0.1Nsilver nitrate.Each mLof 0.1Nsilver nitrate is equivalent to 5.844mg of NaCl.

Expert Committee:(BBP)Blood and Blood Products

USP28–NF23Page 940

Phone Number:1-301-816-8339