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.
Identification
It responds to the tests for
Magnesium 191 and for
Sulfate 191.
pH 791:
between 5.5 and 7.0, when diluted to a concentration of 5% (w/v).
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 ammoniaammonium 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 MgSO
4·7H
2O.