Magnesium Sulfate Injection
» Magnesium Sulfate Injection is a sterile solution of Magnesium Sulfate in Water for Injection. It contains magnesium sulfate equivalent to not less than 93.0 percent and not more than 107.0 percent of the labeled amount of MgSO4·7H2O.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Labeling— The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol per mL.
USP Reference standards 11
USP Endotoxin RS
Identification— It responds to the tests for Magnesium 191 and for Sulfate 191.
Bacterial endotoxins 85 It contains not more than 0.09 USP Endotoxin Unit per mg of magnesium sulfate.
pH 791: between 5.5 and 7.0, when diluted to a concentration of 5% (w/v).
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer to a beaker an accurately measured volume of Injection, equivalent to about 250 mg of anhydrous magnesium sulfate, and dilute with water to 100 mL. Adjust the reaction of the solution to a pH of 7 (using pH indicator paper; see Indicator and Test Papers under Reagents in the section Reagents, Indicators, and Solutions) with 1 N sodium hydroxide, add 5 mL of ammonia–ammonium chloride buffer TS and 0.15 mL of eriochrome black TS, and titrate with 0.05 M edetate disodium VS to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 12.32 mg of MgSO4·7H2O.
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Topic/Question Contact Expert Committee
Monograph Hariram Ramanathan, M.S.
Associate Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3756