PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Sodium chloride
سدیم کلراید، کلرید سدیم، نمک
1Nonproprietary names
- BPSodium Chloride
- JPSodium Chloride
- Ph. Eur.Sodium Chloride
- USP–NFSodium Chloride
2Synonyms and trade names
Common salt; halite; natrii chloridum; rock salt; saline; sea salt; table salt
3Chemical name and CAS Registry Number
Sodium chloride · [7647-14-5]
UNII 451W47IQ8X · PubChem CID 5234
4Empirical formula and molecular weight
NaCl · 58.44
5Functional category
Tonicity-adjusting agent
Typical concentrations: up to 0.9% · Dosage forms: Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Sodium chloride is used mainly to adjust tonicity in parenteral, ophthalmic, nasal and irrigation solutions; a 0.9% w/v solution is iso-osmotic with serum. It is also used as an osmotic agent in osmotic-pump and other controlled-release tablets, as a channelling agent and diluent in tablets and capsules, to raise the viscosity of surfactant-thickened liquids such as shampoos, and to adjust the gelation and swelling of polymers.
7Description
Colourless cubic crystals or a white crystalline powder with a saline taste. It is slightly hygroscopic above about 75% relative humidity.
8Typical properties
- Melting point
- 801 °C
- Solubility
- freely soluble in water (about 1 in 2.8 at 20 °C); slightly soluble in ethanol; soluble in glycerol (about 1 in 10)
- Density
- about 2.17 g/cm³
- Osmolality
- about 290 mOsm/kg for a 0.9% w/v solution
- pH
- 6.7–7.3 (saturated aqueous solution)
9Stability and storage conditions
Very stable. Aqueous solutions are stable and can be sterilised by autoclaving or filtration, but they may cause separation of glass particles from some types of glass container on storage. Store in a well-closed container in a dry place.
10Incompatibilities
Aqueous solutions are corrosive to iron and precipitate silver, lead and mercury salts. Strong oxidising agents liberate chlorine from acidified solutions. Sodium chloride can salt out other solutes, reduce the solubility of some preservatives such as methylparaben, and decrease the viscosity of carbomer gels and some cellulose ether solutions.
11Method of manufacture
Obtained by mining of rock salt, by evaporation of sea water or by evaporation of brine pumped from underground deposits, followed by purification and recrystallisation.
12Safety
Sodium chloride is the main extracellular electrolyte and is non-toxic at excipient levels. Excessive intake or infusion can cause hypernatraemia, fluid retention and raised blood pressure, so the sodium load of formulations should be considered for patients with heart failure, hypertension or renal impairment. Hypertonic solutions are irritant to tissues.
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, inhalation, nasal, ophthalmic, oral, otic, rectal and topical preparations) and in parenteral and non-parenteral medicines licensed in Europe.
15Related substances
Potassium chloride; dextrose; mannitol; glycerin.
16Comments
When calculating the amount of sodium chloride needed to make a solution isotonic, the freezing-point depression or sodium chloride equivalent of the drug and other solutes must be taken into account (a 0.9% solution depresses the freezing point by about 0.52 °C). Grades for parenteral and haemodialysis use have tighter limits on impurities such as bromide, iodide, aluminium and endotoxins.