Sodium carbonate is a white, almost white, or colorless inorganic
salt, produced as crystalline powder or granules. It is hygroscopic
and odorless with an alkaline taste.
Buffer component, may be used for the removal of peripheral membrane proteins.
Sodium Carbonate Monohydrate can be used for sterilization or virus inactivating agent composition.
Sodium carbonate is produced by the ammonia-soda process, also
known as the Solvay process.
Pharmaceutical Applications
Sodium carbonate is used as an alkalizing agent in injectable,
ophthalmic, oral, and rectal formulations.
In effervescent tablets or granules, sodium carbonate is used in
combination with an acid, typically citric acid or tartaric acid.
When the tablets or granules come into contact with water, an acid–
base reaction occurs in which carbon dioxide gas is produced and
the product disintegrates. Raw materials with low moisture
contents are required to prevent the early triggering of the
effervescent reaction.
As an alkalizing agent, concentrations of sodium carbonate
between 2% and 5% w/w are used in compressed tablet
formulations. As an effervescent agent, concentrations of
sodium carbonate up to 10% w/w can be used.
Therapeutically, sodium carbonate is also used as an oral
antacid.
Soda ash is the name of various grades of sodium carbonate (Na2CO3). A large portion
of soda ash is manufactured via the Solvay process, based on the following reaction:
NH3 + CO2 + H2O → NH4HCO3
NaCl + NH4HCO3→ NaHCO3 + NH4Cl
2NaHCO3 + heat → Na2CO3 + CO2 (recycled)
Soda ash is an off-white to white anhydrous powder or granular material. The quality
of soda ash is usually characterized by the percent of sodium oxide (Na2O) content.
The most prominent characteristic of soda ash in solution is the high buffered pH response. For example, changing the sodium carbonate dosage from 0.03% to 30% only causes the solution pH to change from 10.5 to 11.7. Because of this, in mineral processing application, soda ash is used for pH control to a maximum value of 10.5.
Sodium carbonate is used in injectable, oral, and rectal pharmaceutical
formulations. The pure form of sodium carbonate is mildly
toxic by ingestion, moderately toxic by inhalation and SC routes,
and very toxic by the IP route. It is irritating to the skin and eyes.
Dust and vapors of sodium carbonate may irritate mucous
membranes, causing coughing and shortness of breath. It also has
experimental reproductive effects.
Sodium carbonate can migrate to food from packaging
materials. When used as an excipient or antacid, sodium carbonate
is generally regarded as a nontoxic and nonirritating material.
LD50 (mouse, IP): 0.12 g/kg
LD50 (mouse, SC): 2.21 g/kg
LD50 (rat, oral): 4.09 g/kg
Sodium carbonate converts to the monohydrate form when in
contact with water and produces heat. It begins to lose carbon
dioxide at temperatures above 400℃ and decomposes before
boiling. Store in airtight containers.
Sodium carbonate decomposes when in contact with acids in the
presence of water to produce carbon dioxide and effervescence. It
may react violently with aluminum, phosphorous pentoxide,
sulfuric acid, fluorine, and lithium.
GRAS listed. Accepted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (injections;
ophthalmic solution; oral capsules and tablets; rectal suspensions).
Included in the Canadian List of Acceptable Non-medicinal
Ingredients. Included in parenteral (powder for solution for
injection) and nonparenteral medicines (oral effervescent tablets,
soluble tablets, granules, lozenges, chewing gums) licensed in the
UK.
USP32–NF27 allows either the anhydrous or the monohydrate
form.
