Manganese Sulfate Injection
»Manganese Sulfate Injection is a sterile solution of Manganese Sulfate in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of manganese (Mn).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIglass.
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 279nm when tested as directed for Procedurein the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.45USP Endotoxin Unit per µg of manganese.
pHá791ñ: between 2.0and 3.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Sodium chloride solution ,Manganese stock solution,and Standard preparations—Prepare as directed in the Assayunder Manganese Chloride Injection.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 1mg of manganese,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Pipet 10mLof this solution into a 50-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Manganese Chloride Injection.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1183
Phone Number:1-301-816-8178