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Excipient monograph · مونوگراف ماده جانبی
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Sodium thiosulfate
سدیم تیوسولفات
1Nonproprietary names
- BPSodium Thiosulfate
- JPSodium Thiosulfate Hydrate
- Ph. Eur.Sodium Thiosulfate
- USP–NFSodium Thiosulfate
2Synonyms and trade names
Disodium thiosulfate pentahydrate; hypo; natrii thiosulfas; sodium hyposulfite; thiosulfuric acid disodium salt
3Chemical name and CAS Registry Number
Disodium thiosulfate pentahydrate · [7772-98-7]
UNII L0IYT1O31N · PubChem CID 24477
4Empirical formula and molecular weight
Na2S2O3·5H2O (pentahydrate); Na2S2O3 (anhydrous) · 248.17 (pentahydrate); 158.11 (anhydrous)
5Functional category
Antioxidant, chelating agent
Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
As an excipient, sodium thiosulfate is used as an antioxidant and reducing agent in some injections and other preparations, generally at low concentrations. It is better known as an active ingredient: intravenously as an antidote in cyanide poisoning (with sodium nitrite) and to reduce cisplatin-induced ototoxicity, topically for pityriasis versicolor, and in analytical and antiseptic practice to neutralise iodine and chlorine.
7Description
Large, colourless, transparent crystals or a coarse crystalline powder, odourless, with a cooling and slightly bitter, saline taste. The crystals effloresce in warm, dry air and are slightly deliquescent in moist air.
8Typical properties
- Melting point
- the pentahydrate melts in its water of crystallisation at about 48 °C and loses it at about 100 °C
- Solubility
- very soluble in water; practically insoluble in ethanol
- pH
- aqueous solutions are approximately neutral to slightly alkaline
9Stability and storage conditions
Stable in the solid state when stored in an airtight container. Aqueous solutions decompose slowly, especially if acidic, with deposition of sulfur; they are stabilised by a small amount of alkali and can be sterilised by autoclaving.
10Incompatibilities
Decomposed by acids with liberation of sulfur dioxide and precipitation of sulfur. Incompatible with oxidising agents, iodine (which it reduces) and salts of heavy metals such as lead, mercury and silver, with which it forms complexes or precipitates.
11Method of manufacture
Prepared by boiling a solution of sodium sulfite with sulfur, or as a by-product of sulfide dye and sulfur-removal processes, and purified by crystallisation of the pentahydrate.
12Safety
Of low toxicity; it is poorly absorbed orally and acts as an osmotic laxative in large doses. Intravenous use in high doses can cause hypotension, nausea, vomiting and osmotic effects, but excipient levels are not associated with significant toxicity.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.
14Regulatory status
GRAS listed. Included in the FDA Inactive Ingredient Database (injections and other preparations) and in medicines licensed in Europe.
15Related substances
Sodium metabisulfite; sodium sulfite; sodium formaldehyde sulfoxylate.
16Comments
Keep solutions at neutral to slightly alkaline pH to prevent sulfur deposition. The pentahydrate contains about 36% water, which must be allowed for when the anhydrous equivalent is specified.