Sodium Citrate (soe' dee um si' trate). C6H5Na3O7258.07 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, trisodium salt; Trisodium citrate (anhydrous) [68-04-2]. C6H5Na3O7·2H2O294.10 Trisodium citrate dihydrate [6132-04-3]. DEFINITION Sodium Citrate is anhydrous or contains two molecules of water of hydration. It contains NLT 99.0% and NMT 100.5% of C6H5Na3O7, calculated on the anhydrous basis. IDENTIFICATION • A. Identification TestsGeneral, Sodium 191 Sample solution: 50 mg/mL Acceptance criteria: Meets the requirements • B. Identification TestsGeneral, Citrate 191 Sample solution: 50 mg/mL Acceptance criteria: Meets the requirements • C. Upon ignition, it yields an alkaline residue that effervesces when treated with 3 N hydrochloric acid. ASSAY • Procedure Sample: Add 100 mL of glacial acetic acid to 350 mg of Sodium Citrate (previously dried at 180 for 18 h) in a 250-mL beaker. Stir until completely dissolved. Analysis: Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction (see Titrimetry 541). Each mL of 0.1 N perchloric acid is equivalent to 8.602 mg of C6H5Na3O7. Acceptance criteria: 99.0%100.5% on the anhydrous basis IMPURITIES • Heavy Metals 231 [NoteUse 50-mL color comparison tubes for preparing the Standard preparation, Test preparation, and Monitor preparation. ] Standard preparation: 1.0 mL of Standard Lead Solution and 11 mL of water Test stock preparation: 88 mg/mL of anhydrous sodium citrate in water Test preparation: 12 mL of the Test stock preparation Monitor preparation: 11 mL of the Test stock preparation and 1.0 mL of Standard Lead Solution Analysis: Proceed as directed in the chapter for Procedure, omitting the dilution to 50 mL. Acceptance criteria: NMT 10 ppm • Tartrate Analysis: To a solution of 1 g in 2 mL of water in a test tube add 1 mL of potassium acetate TS and 1 mL of 6 N acetic acid. Rub the wall of the tube with a glass rod. Acceptance criteria: No crystalline precipitate is formed. SPECIFIC TESTS • Alkalinity Sample solution: 1.0 g in 20 mL of water Acceptance criteria: The Sample solution is alkaline to litmus paper, but after the addition of 0.20 mL of 0.10 N sulfuric acid, no pink color is produced by 1 drop of phenolphthalein TS. • Water Determination, Method III 921: Dry a sample at 180 for 18 h: the anhydrous form loses NMT 1.0% of its weight; the hydrous form loses 10.0%13.0% of its weight. ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. • Labeling: Label it to indicate whether it is anhydrous or hydrous. Auxiliary Information Please check for your question in the FAQs before contacting USP.
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