Heparin Sodium Injection
» Heparin Sodium Injection is a sterile solution of Heparin Sodium in Water for Injection. It exhibits a potency not less than 90.0 percent and not more than 110.0 percent 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 multiple-dose containers, preferably of Type I glass, 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. 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 85 It contains not more than 0.03 USP Endotoxin Unit per USP Heparin Unit.
pH 791: between 5.0 and 7.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections 1.
Assay— Proceed as directed in the Assay under Heparin Sodium, substituting the Injection for the solution of heparin sodium prepared as directed under Assay preparation. Under Calculation, vU in the equation for R is the volume, in mL, of the Injection per mL of the Assay preparation. The potency of Heparin Sodium Injection in USP Heparin Units per mL is P* = antilog M.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Anita Y. Szajek, Ph.D.
Senior Scientist
(BBBBP05) Biologics and Biotechnology - Blood and Blood Products
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2554