Magnesium Sulfate in Dextrose Injection
»Magnesium Sulfate in Dextrose Injection is a sterile solution of Magnesium Sulfate and Dextrose in Water for Injection.It contains not less than 93.0percent and not more than 107.0percent of the labeled amount of magnesium sulfate (MgSO4·7H2O)and not less than 90.0percent and not more than 110.0percent of the labeled amount of dextrose (C6H12O6·H2O).
Packaging and storage— Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type 1or Type IIglass.
Identification— It responds to the Identificationtest under Dextrose,and to the tests for Magnesium á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.039USP Endotoxin Unit per mg of magnesium sulfate.
pHá791ñ: between 3.5and 6.5.
Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection,equivalent to 1.0g of C6H12O6·H2O,with water to 500.0mL.Determine the absorbance of this solution in a 1-cm cell at 284nm with a spectrophotometer,using water as the blank:the absorbance is not more than 0.25.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for magnesium sulfate— Proceed with Injection as directed in the Assayunder Magnesium Sulfate Injection.
Assay for dextrose— Proceed with Injection as directed in the Assayunder Dextrose Injection.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1176
Phone Number:1-301-816-8330