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 90.0percent and not more than 110.0percent of the labeled amount of (C6H12O6)nand not less than 95.0percent and not more than 105.0percent of the labeled amount of NaCl.It contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass.
Clarity— If particulate matter is present,heat at 100for 30minutes: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 á85ñ— It contains not more than 0.1USP Endotoxin Unit per mg of inulin.
pHá791ñ: between 4.0and 7.0.
Free fructose—
Blue tetrazolium solution,Tetramethylammonium hydroxide solution,Standard stock solution,and Standard preparation— Proceed as directed in the test for Free fructoseunder Inulin.
Test preparation— Transfer an accurately measured volume of Injection,equivalent to about 2.5g of inulin,to a 100-mLvolumetric flask,add water to volume,and mix.Just prior to use,pipet 1mLof this solution into a 100-mLvolumetric flask,dilute with alcohol to volume,mix,and,if the solution is turbid,filter through fine-porosity filter paper.
Procedure— Proceed as directed for Procedurein the test for Free fructoseunder Inulin.Calculate the quantity,F,in mg,of free fructose in each mLof the Injection taken by the formula:
10(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Fructose RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and AUand ASare the absorbances of the solutions from the Test preparationand the Standard preparation,respectively.The limit is 2.2mg per mL.
Other requirements— It meets the other requirements under Injections á1ñ.
Assay for inulin—
Content of combined glucose— Proceed as directed in the Content of combined glucoseunder Inulin,but in preparing the Assay preparationuse,instead of 0.5g of inulin,an accurately measured volume of the Injection equivalent to about 0.5g of inulin.Calculate the quantity,in mg,of combined glucose,G,in each mLof the Injection taken by the formula:
500(C/V)(AU/AS),
in which Cis the concentration,in mg per mL,of USP Dextrose RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Procedure— Proceed as directed in the Assay for inulinunder Inulin.Calculate the quantity,in mg,of (C6H12O6)nin each mLof the Injection taken by the formula:
0.900[25(C/V)(AU/AS)-F]+G,
in which 0.900is the ratio of the formula weight of an anhydrofructose unit of inulin to that of fructose;Cis the concentration,in µg per mL,of USP Fructose RSin the Standard preparation;Vis the volume,in mL,of Injection taken;AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively;and Fis the quantity,in mg,of free fructose in each mLof Injection,and the other terms are as defined therein.
Assay for sodium chloride— Pipet a volume of Injection,equivalent to about 90mg of sodium chloride,into a porcelain casserole,and add 140mLof water and 1mLof dichlorofluorescein TS.Mix,and titrate with 0.1Nsilver nitrate VSuntil the silver chloride flocculates and the mixture acquires a faint pink color.Each mLof 0.1Nsilver nitrate is equivalent to 5.844mg of NaCl.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1029
Pharmacopeial Forum:Volume No.28(6)Page 1817
Phone Number:1-301-816-8305