Manganese Sulfate Injection
» Manganese Sulfate Injection is a sterile solution of Manganese 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 manganese (Mn).
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass.
Labeling Label the Injection to indicate that it is to be diluted to the appropriate strength with Sterile Water for Injection or other suitable fluid prior to administration.
Identification The Assay preparation, prepared as directed in the Assay, exhibits an absorption maximum at about 279 nm when tested as directed for Procedure in the Assay.
Bacterial endotoxins 85 It contains not more than 0.45 USP Endotoxin Unit per µg of manganese.
pH 791: between 2.0 and 3.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Sodium chloride solution, Manganese stock solution, and Standard preparations Prepare as directed in the Assay under Manganese Chloride Injection.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 1 mg of manganese, to a 100-mL volumetric flask, dilute with water to volume, and mix. Pipet 10 mL of this solution into a 50-mL volumetric flask, dilute with water to volume, and mix.
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USP32NF27 Page 2847