Heparin Calcium Injection
»Heparin Calcium Injection is a sterile solution of Heparin Calcium in Water for Injection.It exhibits a potency not less than 90.0percent and not more than 110.0percent of the potency stated on the label in terms of USP Heparin Units per mL.
NOTE—The USP Heparin Unit is defined by the USP Heparin Sodium Reference Standard,independent of International Units.The respective units are not equivalent (see General Notices).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type 1glass,and store at a temperature below 40,preferably at room temperature.
Labeling— Label it to indicate the volume of the total contents and the potency in terms of USP Heparin Units only per mL,except that single-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 also that the entire contents are to be used or,if not,any remaining portion is to be discarded.Label it to indicate also the tissue and the animal species from which it is derived.
Bacterial endotoxins á85ñ— It contains not more than 0.03USP Endotoxin Unit per USP Heparin Unit.
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— Proceed as directed in the Assayunder Heparin Sodium,substituting Heparin Calcium Injection for the solution of heparin sodium prepared as directed for Assay preparation.Under Calculation,Yuin the equation for Ris the volume,in mL,of the Injection per mLof the Assay preparation.The potency of Heparin Calcium Injection in USP Heparin Units per mLis P*=antilog bar(M).
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 941
Phone Number:1-301-816-8339
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