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.

USP Reference standards 11— USP Heparin Sodium RS. USP Endotoxin RS.

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.

Residual solvents 467: meets the requirements.

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 bar(M).

Expert Committee : (BBBBP05) Biologics and Biotechnology - Blood and Blood Products

USP29–NF24 Page 1048

Phone Number : 1-301-816-8385