Mannitol in Sodium Chloride Injection
»Mannitol in Sodium Chloride Injection is a sterile solution of Mannitol and Sodium Chloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amounts of C6H14O6and NaCl.It contains no antimicrobial agents.
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 105
for 4hours:the residue responds to the Identificationtests under Mannitol Injection.
for 4hours:the residue responds to the Identificationtests under Mannitol Injection.
B:
It responds to the tests for Sodium á191ñand for Chloride á191ñ.
Bacterial endotoxins á85ñ—
It contains not more than 0.04USP Endotoxin Unit per mg of mannitol.
pHá791ñ:
between 4.5and 7.0.
Other requirements—
It meets the requirements for Packaging and storageunder Mannitol Injection.It meets also the requirements under Injections á1ñ.
Assay for sodium chloride—
Proceed with Injection as directed in the Assayunder Sodium Chloride Injection.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1184
Phone Number:1-301-816-8305