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Excipient monograph · مونوگراف ماده جانبی
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Sodium acetate
سدیم استات
1Nonproprietary names
- BPSodium Acetate
- Ph. Eur.Sodium Acetate Trihydrate
- USP–NFSodium Acetate
2Synonyms and trade names
Acetic acid, sodium salt; natrii acetas trihydricus; sodium ethanoate; E262
3Chemical name and CAS Registry Number
Sodium acetate trihydrate · [127-09-3]
UNII NVG71ZZ7P0 · PubChem CID 517045
4Empirical formula and molecular weight
C2H3NaO2·3H2O (trihydrate); C2H3NaO2 (anhydrous) · 136.08 (trihydrate); 82.03 (anhydrous)
5Functional category
pH adjuster, buffering agent
Typical concentrations: — · Dosage forms: Liquid, Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Sodium acetate is used, usually together with acetic acid, to prepare acetate buffers in the pH range of about 3.8–5.8 for injections, ophthalmic, oral and topical preparations. It is also used as an electrolyte source and systemic alkalising agent in parenteral nutrition and in haemodialysis and peritoneal dialysis solutions, where acetate is metabolised to bicarbonate. Buffer concentrations are typically low, of the order of 0.1–1% w/v.
7Description
Colourless, transparent crystals or a white granular crystalline powder, with a faint acetic odour and a saline taste. The trihydrate effloresces in warm, dry air; the anhydrous form is hygroscopic.
8Typical properties
- pKa (acetic acid)
- 4.76 at 25 °C
- pH
- 7.5–9.2 (5% w/v aqueous solution)
- Melting point
- trihydrate melts in its water of crystallisation at about 58 °C and becomes anhydrous above about 120 °C
- Solubility
- very soluble in water; soluble in ethanol
9Stability and storage conditions
Stable when stored in an airtight container. Aqueous solutions can be sterilised by autoclaving.
10Incompatibilities
Incompatible with strong oxidising agents and strong acids. As an alkaline salt it may precipitate drugs that are poorly soluble at higher pH, and acetate ions may react with some metal salts.
11Method of manufacture
Made by neutralising acetic acid with sodium carbonate or sodium hydroxide and crystallising the trihydrate from the solution.
12Safety
Sodium acetate is a normal metabolic intermediate and is regarded as non-toxic at the concentrations used as an excipient. Excessive parenteral administration can cause metabolic alkalosis and sodium overload, so the acetate and sodium load of large-volume infusions must be taken into account.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E262). Included in the FDA Inactive Ingredient Database (injections, ophthalmic, oral and topical preparations) and in parenteral and non-parenteral medicines licensed in Europe.
15Related substances
Acetic acid; potassium acetate; sodium citrate dihydrate; sodium lactate.
16Comments
Specify which form (trihydrate or anhydrous) is used, since the trihydrate contains about 40% water and quantities must be corrected accordingly. Acetate buffers have their greatest capacity close to pH 4.8.