U.S. PHARMACOPEIA

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Inulin in Sodium Chloride Injection
» Inulin in Sodium Chloride Injection is a sterile solution, which may be supersaturated, of Inulin and Sodium Chloride in Water for Injection. It may require heating before use if crystallization has occurred. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of (C6H12O6)n and not less than 95.0 percent and not more than 105.0 percent of the labeled amount of NaCl. It contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers, preferably of Type I or Type II glass.
Clarity— If particulate matter is present, heat at 100 for 30 minutes: the resulting solution is free from turbidity and particulate matter.
NOTE—Before applying the following tests, dissolve any solid matter by heating, and cool to room temperature.
Bacterial endotoxins 85— It contains not more than 0.1 USP Endotoxin Unit per mg of inulin.
pH 791: between 4.0 and 7.0.
Free fructose—
Blue tetrazolium solution, Tetramethylammonium hydroxide solution, Standard stock solution, and Standard preparation— Proceed as directed in the test for Free fructose under Inulin.
Test preparation— Transfer an accurately measured volume of Injection, equivalent to about 2.5 g of inulin, to a 100-mL volumetric flask, add water to volume, and mix. Just prior to use, pipet 1 mL of this solution into a 100-mL volumetric flask, dilute with alcohol to volume, mix, and, if the solution is turbid, pass through fine-porosity filter paper.
Procedure— Proceed as directed for Procedure in the test for Free fructose under Inulin. Calculate the quantity, F, in mg, of free fructose in each mL of the Injection taken by the formula:
10(C / V)(AU / AS),
in which C is the concentration, in µg per mL, of USP Fructose RS in the Standard preparation; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the solutions from the Test preparation and the Standard preparation, respectively. The limit is 2.2 mg per mL.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the other requirements under Injections 1.
Assay for inulin—
Content of combined glucose— Proceed as directed in the Content of combined glucose under Inulin, but in preparing the Assay preparation use, instead of 0.5 g of inulin, an accurately measured volume of the Injection equivalent to about 0.5 g of inulin. Calculate the quantity, in mg, of combined glucose, G, in each mL of the Injection taken by the formula:
500(C / V)(AU / AS),
in which C is the concentration, in mg per mL, of USP Dextrose RS in the Standard preparation; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
Procedure— Proceed as directed in the Assay for inulin under Inulin. Calculate the quantity, in mg, of (C6H12O6)n in each mL of the Injection taken by the formula:
0.900[25(C / V)(AU / AS) F] + G,
in which 0.900 is the ratio of the formula weight of an anhydrofructose unit of inulin to that of fructose; C is the concentration, in µg per mL, of USP Fructose RS in the Standard preparation; V is the volume, in mL, of Injection taken; AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively; and F is the quantity, in mg, of free fructose in each mL of Injection, and the other terms are as defined therein.
Assay for sodium chloride— Pipet a volume of Injection, equivalent to about 90 mg of sodium chloride, into a porcelain casserole, and add 140 mL of water and 1 mL of dichlorofluorescein TS. Mix, and titrate with 0.1 N silver nitrate VS until the silver chloride flocculates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of NaCl.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 1142
Pharmacopeial Forum : Volume No. 28(6) Page 1817
Phone Number : 1-301-816-8305