Sodium Acetate IP Pharma Grade
Dry Basis Assay: 99 to 101%
Characteristics: Colourless Crystals
Solubility: Soluble in 0.8 part of water and in 19 parts of Ethanol (96%)
Clarity and colour of 10% w/v solution: Clear and Colourless
Alkalinity (pH of 5% solution): 7.5-9.0
Arsenic: 2 ppm maximum
Calcium and Magnesium (calculated as Ca): 50 ppm maximum
Heavy Metals as Lead: 10 ppm maximum
Iron: 10 ppm maximum
Chloride: 200 ppm maximum
Sulphate: 200 ppm maximum
Reducing Substances: Passes test
Sodium Acetate Trihydrate BP Specifications
Sodium Acetate BP
Action and use
Used in solutions for dialysis; excipient.
Sodium ethanoate trihydrate.
99.0 per cent to 101.0 per cent (dried substance).
Very soluble in water, soluble in ethanol (96 per cent).
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).
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.
7.5 to 9.0.
Dilute 5 ml of solution S to 10 ml with carbon dioxide-free water.
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.
Maximum 200 ppm.
Maximum 200 ppm.
Maximum 0.2 ppm, if intended for use in the manufacture of dialysis solutions.
Maximum 2 ppm, determined on 0.5 g.
Calcium and magnesium
Maximum 50 ppm, calculated as Ca.
Maximum 10 ppm.
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 USP Specifications
Sodium Acetate USP
Assay— Sodium Acetate contains three molecules of water of hydration, or is anhydrous. It contains not less than 99.0 percent and not more than 101.0 percent of C2H3NaO2, calculated on the dried basis.
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 hem dialysis, it is so labeled.
Identification— A solution responds to the test for Sodium and for Acetate.
pH: between 7.5 and 9.2, in a solution in carbon dioxide-free water containing the equivalent of 30 mg of anhydrous sodium acetate per mL.
Loss on drying— Dry at 120 to constant weight: the hydrous form loses between 38.0% and 41.0% of its weight, and the anhydrous form loses not more than 1.0% of its weight.
Insoluble matter— Dissolve the equivalent of 20 g of anhydrous sodium acetate in 150 mL of water, heat to boiling, and digest in a covered beaker on a steam bath for 1 hour. Filter through a tarred filtering crucible, wash thoroughly, and dry at 105 : the weight of the residue does not exceed 10 mg (0.05%).
Chloride— 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 (0.035%).
Sulfate— 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 (0.005%).
Calcium and magnesium— To 20 mL of a solution containing the equivalent of 10 mg of anhydrous sodium acetate per mL add 2 mL each of 6 N ammonium hydroxide, ammonium oxalate TS, and dibasic sodium phosphate TS: no turbidity is produced within 5 minutes.
Potassium— Dissolve the equivalent of 3 g of anhydrous sodium acetate in 5 mL of water, add 1N acetic acid drop wise until the solution is slightly acidic, and then add 5 drops of sodium cobalt nitrite TS: no precipitate is formed.
Aluminum: (where it is labeled as intended for use in hem dialysis)— the limit is 0.2µ =g per g.
Heavy metals—the limit is 0.001%.
Organic volatile impurities: meets the requirements.
Sodium Acetate FCC Food Grade, US Food Chemical Codex
C2H3NaO2 Formula wt, anhydrous 82.03
C2H3NaO2·3H2O Formula wt, trihydrate 136.08
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.
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.
Shelf life, Storage and Packing
It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.
GLP, cGMP (FDA) Approved, WHO-GMP, ISO 9001: 2015, ISO14001:2015, OHSAS18001:2007, FSSC 22000: 2005, FSSAI, Kosher and Halal Certified.