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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 93.0 percent and not more than 107.0 percent of the labeled amount of magnesium sulfate (MgSO4·7H2O) and not less than 90.0 percent and not more than 110.0 percent 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 1 or Type II glass.
Identification— It responds to the Identification test under Dextrose, and to the tests for Magnesium 191.
Bacterial endotoxins 85— It contains not more than 0.039 USP Endotoxin Unit per mg of magnesium sulfate.
pH 791: between 3.5 and 6.5.
Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection, equivalent to 1.0 g of C6H12O6·H2O, with water to 500.0 mL. Determine the absorbance of this solution in a 1-cm cell at 284 nm with a spectrophotometer, using water as the blank: the absorbance is not more than 0.25.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay for magnesium sulfate— Proceed with Injection as directed in the Assay under Magnesium Sulfate Injection.
Assay for dextrose— Proceed with Injection as directed in the Assay under Dextrose Injection.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1303
Phone Number : 1-301-816-8330