Fructose and Sodium Chloride Injection
» Fructose and Sodium Chloride Injection is a sterile solution of Fructose 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 C6H12O6 (fructose) and of NaCl (sodium chloride). Fructose and Sodium Chloride Injection contains no antimicrobial agents.
Packaging and storage—
Preserve in single-dose containers, 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.
Identification—
It responds to the Identification tests under Fructose Injection and to the tests for Sodium 
191
and for Chloride 191.
191 and for Chloride 191.
Bacterial endotoxins 85—
It contains not more than 0.5 USP Endotoxin Unit per mL.
85—
It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791:
between 3.0 and 6.0.
791:
between 3.0 and 6.0.
Heavy metals, Method I 231—
Proceed as directed in the test for Heavy metals under Fructose Injection: the limit is 5 ppm.
231—
Proceed as directed in the test for Heavy metals under Fructose Injection: the limit is 5 ppm.
Limit of hydroxymethylfurfural—
It meets the requirements of the test for Hydroxymethylfurfural under Fructose.
Other requirements—
It meets the requirements under Injections 1.
1.
Assay for fructose—
Transfer an accurately measured volume of Injection, containing about 5 g of fructose, to a 100-mL volumetric flask, add 0.2 mL of 6 N ammonium hydroxide, dilute with water to volume, and mix. After 30 minutes determine the angular rotation (see Optical Rotation 781), and record the observed rotation, a, as an absolute number. Calculate the quantity, in mg, of fructose (C6H12O6) in each mL of the Injection taken by the formula:
781), and record the observed rotation, a, as an absolute number. Calculate the quantity, in mg, of fructose (C6H12O6) in each mL of the Injection taken by the formula:
1124a / lV
in which l is the length, in dm, of the polarimeter tube; and V is the volume, in mL, of Injection taken.
Assay for sodium chloride—
Transfer an accurately measured volume of Injection, equivalent to about 90 mg of sodium chloride, to a conical flask, evaporate to a volume of about 10 mL, and add 10 mL of glacial acetic acid, 75 mL of methanol, and 0.5 mL of eosin Y TS. Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride (NaCl).
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Daniel K. Bempong, Ph.D.
Senior Scientist 1-301-816-8143 |
(MDPS05) Monograph Development-Pulmonary and Steroids |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 2456