Sodium Acetate (soe' dee um as' e tate). C2H3NaO2·3H2O136.08 C2H3NaO282.03 Acetic acid, sodium salt, trihydrate; Sodium acetate trihydrate [6131-90-4]. Anhydrous [127-09-3]. DEFINITION Sodium Acetate contains three molecules of water of hydration, or is anhydrous. It contains NLT 99.0% and NMT 101.0% of C2H3NaO2, calculated on the dried basis. IDENTIFICATION • A. Identification TestsGeneral, Sodium 191: Meets the requirements • B. Identification TestsGeneral, Acetate 191: Meets the requirements Sample solution (for Lanthanum Nitrate test): 10 mg/mL of sodium acetate in water. Adjust with 0.1 N sodium hydroxide to a slightly alkaline pH. ASSAY • Procedure Sample solution: Equivalent to 200 mg of anhydrous sodium acetate in 25 mL of glacial acetic acid. [NoteWarm gently and mix to dissolve, if necessary. ] Analysis: Add 2 drops of p-naphtholbenzein TS to the Sample solution, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 8.203 mg of C2H3NaO2. Acceptance criteria: 99.0%101.0% on the dried basis IMPURITIES Inorganic Impurities • Chloride and Sulfate, Chloride 221: A portion equivalent to 1.0 g of anhydrous sodium acetate shows no more chloride than corresponds to 0.50 mL of 0.020 N hydrochloric acid (350 ppm). • Chloride and Sulfate, Sulfate 221: A portion equivalent to 10 g of anhydrous sodium acetate shows no more sulfate than corresponds to 0.50 mL of 0.020 N sulfuric acid (50 ppm). • Calcium and Magnesium Sample solution: Equivalent to 10 mg/mL of anhydrous sodium acetate Analysis: To 20 mL of Sample solution add 2 mL each of 6 N ammonium hydroxide, ammonium oxalate TS, and dibasic sodium phosphate TS. Acceptance criteria: No turbidity is produced within 5 min. • Potassium Sample solution: Equivalent to 600 mg/mL of anhydrous sodium acetate Analysis: To 5 mL of Sample solution add 1 N acetic acid dropwise until the solution is slightly acidic, and then add 5 drops of sodium cobaltinitrite TS. Acceptance criteria: No precipitate is formed. • Aluminum 206: Where it is labeled as intended for use in hemodialysis, proceed as directed in the chapter, using a portion equivalent to 10 g of sodium acetate trihydrate to prepare the Sample solution. Acceptance criteria: 0.2 ppm • Heavy Metals, Method I 231 Standard solution: 1 mL of Standard Lead Solution and 11 mL of water in a 50-mL color-comparison tube Sample stock solution: Dissolve the equivalent of 4.2 g of anhydrous sodium acetate in water to make 50 mL Sample solution: 12 mL of Sample stock solution in a 50-mL color-comparison tube Monitor solution: 11 mL of Sample stock solution and 1.0 mL of Standard Lead Solution in a 50-mL color-comparison tube Analysis: Proceed as directed in the chapter, omitting the dilution to 50 mL. Acceptance criteria: NMT 10 ppm SPECIFIC TESTS • pH 791: 7.59.2, in a solution equivalent to 30 mg/mL of anhydrous sodium acetate in carbon dioxide-free water • Loss on Drying 731: Dry a sample at 120 to constant weight: the hydrous form loses 38.0%41.0% of its weight, and the anhydrous form loses NMT 1.0% of its weight. • Insoluble Matter Sample: Equivalent to 20 g of anhydrous sodium acetate Analysis: Dissolve the Sample in 150 mL of water, heat to boiling, and digest in a covered beaker on a steam bath for 1 h. Filter through a tared filtering crucible, wash thoroughly, and dry at 105. Acceptance criteria: The weight of the residue is NMT 10 mg (0.05%). ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. • Labeling: Label it to indicate whether it is the trihydrate or is anhydrous. Where Sodium Acetate is intended for use in hemodialysis, it is so labeled. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4644 Pharmacopeial Forum: Volume No. 36(2) Page 430Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |