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.
USP Reference standards 11
USP Endotoxin RS
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.
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— Please check for your question in the FAQs before contacting USP.
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Monograph Hariram Ramanathan, M.S.
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85 Radhakrishna S Tirumalai, Ph.D.
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