Packaging and storage—
Preserve in
Containers for Sterile Solids as described under
Injections 
1
. Preserve the accompanying solvent in single-dose or in multiple-dose containers, preferably of Type I glass.
Labeling—
Label it to indicate the approximate neutralization capacity in USP Heparin Units.
Constituted solution—
At the time of use, it meets the requirements for
Constituted Solutions under
Injections 1.
pH and clarity of solution—
Dissolve it in the solvent recommended in the labeling: the pH of the solution is between 6.5 and 7.5, and the solution is clear.
Assay—
Using as the
Assay preparation a solution prepared by dissolving the contents of 1 container of Protamine Sulfate for Injection in Water for Injection to give a final concentration of about 1 mg of protamine sulfate per mL, proceed as directed in the
Assay under
Protamine Sulfate. Calculate the potency, in mg, of protamine sulfate in each mL of the
Assay preparation taken by the formula:
v / V,
in which
v and
V are the volumes, in mL, respectively, of the
Heparin preparation and the
Assay preparation present in the last tube prior to the first one in which the clotting time is not less than 2 seconds longer than in the control tube.
