Zinc Sulfate Injection
» Zinc Sulfate Injection is a sterile solution of Zinc Sulfate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of zinc (Zn).
Packaging and storage Preserve in single-dose or multiple-dose containers.
Labeling Label the Injection in terms of its content of anhydrous zinc sulfate (ZnSO4) and in terms of its content of elemental zinc. Label it to state that it is not intended for direct injection but is to be added to other intravenous solutions.
USP Reference standards 11
USP Endotoxin RS
Bacterial endotoxins 85 It contains not more than 25.0 USP Endotoxin Units per mg of zinc.
pH 791: between 2.0 and 4.0.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Assay [noteThe Standard preparations and the Assay preparation may be diluted quantitatively with water, if necessary, to yield solutions of suitable concentrations adaptable to the linear or working range of the instrument. ]
Standard preparations and Assay preparationProceed as directed in the Assay under Zinc Chloride Injection.
Procedure Concomitantly determine the absorbances of the Standard preparations and the Assay preparation at the zinc emission line of 213.8 nm with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering 851) equipped with a zinc hollow-cathode lamp and an airacetylene flame, using water as the blank. Plot the absorbances of the Standard preparations versus concentration, in µg per mL, of zinc, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the concentration, in µg per mL, of zinc in the Assay preparation. Determine the concentration, in mg per mL, of Zn in the Injection taken by the formula:
5C / Vin which C is the concentration, in µg per mL, of zinc in the Assay preparation; and V is the volume, in mL, of Injection taken.
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USP35NF30 Page 5076