» Mannitol Injection is a sterile solution, which may be supersaturated, of Mannitol in Water for Injection. It may require warming or autoclaving before use if crystallization has occurred. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of mannitol (C6H14O6). It contains no antimicrobial agents.
Packaging and storage Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II 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. The label also states that it should be warmed before use to dissolve any crystals that may have formed.
USP Reference standards 11
USP Endotoxin RS
A: Evaporate a portion of Injection on a steam bath to dryness, and dry the residue at 105 for 4 hours. To 3 mL of freshly prepared solution of catechol in water (1 in 10) add 6 mL of sulfuric acid with cooling. Place 3 mL of this solution in each of two separate test tubes. To one tube add 0.3 mL of water (reagent blank) and to the other add 0.3 mL of a solution of it in water (1 in 10). Heat the tubes over an open flame for about 30 seconds: the solution in the tube containing mannitol is dark pink or wine red, and the solution in the tube containing the reagent blank is light pink.
B: The retention time for the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Specific rotation 781 Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask: it meets the requirements of the test for Specific rotation under Mannitol.
Bacterial endotoxins 85 It contains not more than 0.04 USP Endotoxin Unit per mg of mannitol where the labeled amount of mannitol in the Injection is 10% or less, and not more than 2.5 USP Endotoxin Units per g of mannitol where the labeled amount of mannitol in the Injection is greater than 10%.
pH 791: between 4.5 and 7.0, determined potentiometrically, on a portion to which 0.30 mL of saturated potassium chloride solution has been added for each 100 mL, and which previously has been diluted with water, if necessary, to a concentration of not more than 5% of mannitol.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Mannitol.
Standard preparation Dissolve an accurately weighed quantity of USP Mannitol RS in water, and dilute quantitatively with water to obtain a solution having a known concentration of about 5 mg per mL.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 500 mg of mannitol, to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Mannitol. Calculate the quantity, in mg, of mannitol (C6H14O6) in each mL of the Injection taken by the formula:
100(C/V)(rU / rS)in which V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
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USP35NF30 Page 3766Pharmacopeial Forum: Volume No. 28(1) Page 73