Citric Acid,Magnesium Oxide,and Sodium Carbonate Irrigation
»Citric Acid,Magnesium Oxide,and Sodium Carbonate Irrigation is a sterile solution of Citric Acid,Magnesium Oxide,and Sodium Carbonate in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amounts of citric acid (C6H8O7·H2O),magnesium oxide (MgO),and sodium carbonate (Na2CO3).
Packaging and storage
Preserve in single-dose containers,preferably of Type Ior Type IIglass.
Identification
A:
It responds to the tests for Sodium á191ñand for Magnesium á191ñ.
B:
To 10mLof the Irrigation add 1mLof mercuric sulfate TS,heat to boiling,and add a few drops of potassium permanganate TS:a white precipitate is formed.
Bacterial endotoxins á85ñ
It contains not more than 2.80Endotoxin Unit per mL.
pHá791ñ:
between 3.8and 4.2.
Other requirements
It meets the requirements under Injections á1ñ,except that the container may be designed to empty rapidly,and may exceed 1000mLin capacity.
Assay for citric acid
Mobile phase
Add 2.0mLof sulfuric acid to 800mLof water,mix,and dilute with water to 1000mL.Filter through a membrane filter,heat to 40
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Standard preparation
Dissolve a suitable quantity of anhydrous citric acid,accurately weighed,in water to obtain a solution having a known concentration of about 1.2mg per mL.
Resolution solution
Prepare a solution in water containing about 1mg of citric acid and about 2mg of boric acid per mL.
Assay preparation
Transfer an accurately measured volume of Irrigation,equivalent to about 130mg of citric acid monohydrate,to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Chromatographic system
(see Chromatography á621ñ)The liquid chromatograph is equipped with a refractive index detector and a 7.8-mm ×30-cm column that contains packing L17.The column temperature is maintained at 40
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Procedure
Separately inject equal volumes (about 50µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C6H8O7·H2Oin each mLof the Irrigation taken by the formula:
(210.14/192.12)(100C/V)(rU/rS),
in which 210.14and 192.12are the molecular weights of citric acid monohydrate and anhydrous citric acid,respectively,Cis the concentration,in mg per mL,of anhydrous citric acid in the Standard preparation,Vis the volume,in mL,of Irrigation taken,and rUand rSare the peak responses for citric acid obtained from the Assay preparationand the Standard preparation,respectively.
Assay for magnesium oxide
Transfer an accurately measured volume of Irrigation,equivalent to about 40mg of magnesium oxide,to a beaker containing 130mLof water heated to 75±5
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Assay for sodium carbonate
Sodium chloride stock solution
Transfer 475mg of sodium chloride,previously dried at 105
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Internal standard solution
Transfer 636mg of lithium chloride to a 1000-mLvolumetric flask,dissolve in water,dilute with water to volume,and mix.
Standard preparation
Quantitatively prepare a mixture of Internal standard solutionand Sodium chloride stock solution(99:1).
Assay preparation
Dilute an accurately measured volume of Irrigation quantitatively with water to obtain a stock solution containing about 4.4mg of sodium carbonate per mL.Quantitatively prepare a mixture of Internal standard solutionand this stock solution (99:1).
Procedure
Concomitantly determine the emittances of the Standard preparationand the Assay preparationat 591nm and 671nm with a suitable flame photometer,adjusting the instrument to zero emittance with Internal standard solution.Calculate the quantity,in mg,of Na2CO3in each mLof the Irrigation taken by the formula:
(105.99/116.88)(C)(L/D)(RU,591/RU,671)(RS,671/RS,591),
in which 105.99is the molecular weight of sodium carbonate,116.88is two times the molecular weight of sodium chloride,Cis the concentration,in mg per mL,of sodium chloride in the Sodium chloride stock solution,Lis the labeled quantity,in mg per mL,of sodium carbonate in the Irrigation,Dis the concentration,in mg per mL,of sodium carbonate in the stock solution used to prepare the Assay preparation,on the basis of the labeled quantity in each mL,and the extent of dilution,RU,591and RU,671are the emittance readings obtained from the Assay preparationat the wavelengths indicated by the subscripts,and RS,671and RS,591are the emittance readings obtained from the Standard preparationat the wavelengths indicated by the subscripts.
Auxiliary Information
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28NF23Page 486
Phone Number:1-301-816-8394
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