Zinc Sulfate Oral Solution
» Zinc Sulfate Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of zinc sulfate (ZnSO4·H2O). It may contain one or more suitable flavors and sweeteners.
Packaging and storage
Preserve in well-closed containers protected from light, and store in a cool, dry place.
Labeling
Label the Oral Solution in terms of zinc sulfate (ZnSO4·H2O) and in terms of elemental zinc.
pH 791:
between 2.5 and 4.5.
Specific gravity 841:
between 1.18 and 1.24.
Assay
Transfer to a 250-mL flask an accurately measured volume of Oral Solution, equivalent to about 99 mg of ZnSO4·H2O. Add 50 mL of water and 10 mL of ammoniaammonium chloride buffer TS and 0.3 mL of eriochrome black TS, and titrate with 0.05 M edetate disodium VS to a green endpoint. Each mL of 0.05 M edetate disodium is equivalent to 8.973 mg of zinc sulfate (ZnSO4·H2O).
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3899
Pharmacopeial Forum: Volume No. 31(2) Page 468
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