Mannitol Injection
»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 95.0percent and not more than 105.0percent 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 Ior Type IIglass.
Labeling— The label states the total osmolar concentration in mOsmol per L.Where the contents are less than 100mL,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—
A: Evaporate a portion of Injection on a steam bath to dryness,and dry the residue at 105for 4hours.To 3mLof freshly prepared solution of catechol in water (1in 10)add 6mLof sulfuric acid with cooling.Place 3mLof this solution in each of two separate test tubes.To one tube add 0.3mLof water (reagent blank)and to the other add 0.3mLof a solution of it in water (1in 10).Heat the tubes over an open flame for about 30seconds: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 preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Specific rotation á781ñ— Transfer an accurately measured volume of Injection,equivalent to about 1g of mannitol as determined by the Assay,to a 100-mLvolumetric flask:it meets the requirements of the test for Specific rotationunder Mannitol.
Bacterial endotoxins á85ñ— It contains not more than 0.04USP Endotoxin Unit per mg of mannitol where the labeled amount of mannitol in the Injection is 10%or less,and not more than 2.5USP Endotoxin Units per g of mannitol where the labeled amount of mannitol in the Injection is greater than 10%.
pHá791ñ: between 4.5and 7.0,determined potentiometrically,on a portion to which 0.30mLof saturated potassium chloride solution has been added for each 100mL,and which previously has been diluted with water,if necessary,to a concentration of not more than 5%of mannitol.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Resolution solution,andChromatographic system— Proceed as directed in the Assayunder Mannitol.
Standard preparation— Dissolve an accurately weighed quantity of USP Mannitol RSin water,and dilute quantitatively with water to obtain a solution having a known concentration of about 5mg per mL.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 500mg of mannitol,to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Mannitol.Calculate the quantity,in mg,of mannitol (C6H14O6)in each mLof the Injection taken by the formula:
100(C/V)(rU/rS),
in which Vis the volume,in mL,of Injection taken;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1184
Pharmacopeial Forum:Volume No.28(1)Page 73
Phone Number:1-301-816-8305