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 95.0 percent and not more than 105.0 percent of the labeled amounts of C6H14O6 and NaCl. It contains no antimicrobial agents.
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.
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Identification—
A:
Evaporate a portion of Injection on a steam bath to dryness, and dry the residue at 105
for 4 hours: the residue responds to the Identification test A under Mannitol Injection.
for 4 hours: the residue responds to the Identification test A under Mannitol Injection.
B:
It responds to the tests for Sodium 
191
and for Chloride 191.
191 and for Chloride 191.
Bacterial endotoxins 85—
It contains not more than 0.04 USP Endotoxin Unit per mg of mannitol.
85—
It contains not more than 0.04 USP Endotoxin Unit per mg of mannitol.
pH 791:
between 4.5 and 7.0.
791:
between 4.5 and 7.0.
Other requirements—
It meets the requirements for Packaging and storage under Mannitol Injection. It meets also the requirements under Injections 1.
1.
Assay for mannitol—
Proceed with Injection as directed in the Assay under Mannitol Injection.
Assay for sodium chloride—
Proceed with Injection as directed in the Assay under Sodium Chloride Injection.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison 1-301-816-8349 |
(SM22010) Monographs - Small Molecules 2 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 3767