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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.
Identification— It responds to the tests for Zinc 191 and for Sulfate 191.
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— [NOTE—The 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 preparation—Proceed 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 air–acetylene 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 / V,
in 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.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 2292
Phone Number : 1-301-816-8320