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Sodium Acetate Trihydrate BP Specifications
Sodium Acetate BP
C2H3NaO2,3H2O
Action and use
Used in solutions for dialysis; excipient.
DEFINITION
Sodium ethanoate trihydrate.
Content
99.0 per cent to 101.0 per cent (dried substance).
CHARACTERS
Appearance
Colourless crystals.
Solubility
Very soluble in water, soluble in ethanol (96 per cent).
IDENTIFICATION
A. 1 ml of solution S (see Tests) gives reaction (b) of acetates.
B. 1 ml of solution S gives reaction (a) of sodium.
C. Loss on drying (As shown in the Relevant Test).
TESTS
Solution S
Dissolve 10.0 g in carbon dioxide-free water prepared from distilled water R and dilute to 100 ml 100 ml with the same solvent.
Appearance of solution
Solution S is clear and colourless.
pH
7.5 to 9.0.
Dilute 5 ml of solution S to 10 ml with carbon dioxide-free water.
Reducing substances
Dissolve 5.0 g in 50 ml of water, then add 5 ml of dilute sulphuric acid and 0.5 ml of 0.002 M potassium permanganate. The pink colour persists for at least 1 h. Prepare a blank in the same manner but without the substance to be examined.
Chlorides
Maximum 200 ppm.
Sulphates
Maximum 200 ppm.
Aluminium
Maximum 0.2 ppm, if intended for use in the manufacture of dialysis solutions.
Arsenic
Maximum 2 ppm, determined on 0.5 g.
Calcium and magnesium
Maximum 50 ppm, calculated as Ca.
Heavy metals
Maximum 10 ppm.
Iron
Maximum 10 ppm, determined on 10 ml of solution S.
Loss on drying
39.0 per cent to 40.5 per cent, determined on 1.000 g by drying in an oven at 130C.
Sodium Acetate FCC Food Grade, US Food Chemical Codex
C2H3NaO2 Formula wt, anhydrous 82.03
C2H3NaO2·3H2O Formula wt, trihydrate 136.08
DESCRIPTION
Sodium Acetate occurs as colorless, transparent crystals or as a granular, crystalline or white powder. The anhydrous form is hygroscopic; the trihydrate effloresces in warm, dry air. One gram of the anhydrous form dissolves in about 2 mL of water; 1 g of the trihydrate dissolves in about 0.8 mL of water and in about 19 mL of alcohol.
Function: Buffer.
REQUIREMENTS
Identification: A 1:20 aqueous solution gives positive tests for Sodium and for Acetate.
Assay: Not less than 99.0% and not more than 101.0% of C2H3NaO2 after drying.
Alkalinity Anhydrous: Not more than 0.2%; Trihydrate: Not more than 0.05%.
Lead: Not more than 2 mg/kg.
Loss on Drying: Anhydrous: Not more than 1.0%; Trihydrate: Between 36.0% and 41.0%.
Potassium Compounds: Passes test.
