Diatrizoate Sodium Injection
»Diatrizoate Sodium Injection is a sterile solution of Diatrizoate Sodium in Water for Injection,or a sterile solution of Diatrizoic Acid in Water for Injection prepared with the aid of Sodium Hydroxide.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of diatrizoate sodium (C11H8I3N2NaO4).It may contain small amounts of suitable buffers and of Edetate Calcium Disodium or Edetate Disodium as a stabilizer.Diatrizoate Sodium Injection intended for intravascular use contains no antimicrobial agents.
Packaging and storage— Preserve Injection intended for intravascular injection in single-dose containers,preferably of Type Ior Type IIIglass,protected from light.Injection intended for other than intravascular use may be packaged in 100-mLmultiple-dose containers,preferably of Type Ior Type IIIglass,protected from light.
Labeling— Label containers of Injection intended for intravascular injection to direct the user to discard any unused portion remaining in the container.Label containers of Injection intended for other than intravascular injection to show that the contents are not intended for intravascular injection.
Identification—
A: Dilute a volume of Injection,if necessary,with a 0.8in 1000solution of sodium hydroxide in methanol to obtain a test solution having a concentration of 1mg per mL.The test solution responds to the Thin-layer Chromatographic Identification Test á201ñ,the Standard solution being prepared at a concentration of 1mg of USP Diatrizoic Acid RSper mLin a 0.8in 1000solution of sodium hydroxide in methanol,the solvent mixture being a mixture of chloroform,methanol,and ammonium hydroxide (20:10:2),and short-wavelength UVlight being used to locate the spots.
B: Evaporate a volume of Injection,equivalent to about 500mg of diatrizoate sodium,to dryness,and heat the residue so obtained in a crucible:violet vapors are evolved.
Bacterial endotoxins á85ñ— It contains not more than 5.6USP Endotoxin Units per mLfor Injections containing 20%of diatrizoate sodium;not more than 1.3USP Endotoxin Units per mLfor Injections containing 25%of diatrizoate sodium;and not more than 5.0USP Endotoxin Units per mLfor Injections containing 50%of diatrizoate sodium.
pHá791ñ: between 6.0and 7.7.
Iodine and iodide— Using a volume of Injection equivalent to 2.0g of diatrizoate sodium,and diluting it with water to 24mLin a 50-mLcentrifuge tube provided with a stopper,proceed as directed for Procedurein the test for Iodine and iodideunder Diatrizoate Meglumine.
Heavy metals á231ñ— In a 50-mLcolor-comparison tube mix a volume of Injection,equivalent to 1.0g of diatrizoate sodium,with 5mLof 1Nsodium hydroxide,dilute with water to 40mL,and mix.Using this as the Test preparation,proceed as directed in the test for Heavy metalsunder Diatrizoate Meglumine:the limit is 0.002%.
Free aromatic amine— Transfer a volume of Injection,equivalent to 1.0g of diatrizoate sodium,to a 50-mLvolumetric flask,dilute with water to 5mL,and add 10mLof 0.1Nsodium hydroxide.Proceed as directed in the test for Free aromatic amineunder Diatrizoate Meglumine,beginning with “To a second 50-mLvolumetric flask transfer 4mLof water.”
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Pipet into a glass-stoppered 125-mLconical flask a volume of Injection,equivalent to about 500mg of diatrizoate sodium.Add 30mLof 1.25Nsodium hydroxide and 500mg of powdered zinc,and reflux the mixture for 1hour.Cool to room temperature,wash the condenser with 20mLof water,and filter the mixture.Wash the flask and the filter with small portions of water,adding the washings to the filtrate.Add to the filtrate 5mLof glacial acetic acid and 1mLof tetrabromophenolphthalein ethyl ester TS,and titrate with 0.05Nsilver nitrate VSuntil the color of the yellow precipitate just changes to green.Each mLof 0.05Nsilver nitrate is equivalent to 10.60mg of C11H8I3N2NaO4.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 616
Phone Number:1-301-816-8305