6100-05-6/Potassium citrate

Production Methods

Potassium citrate is prepared by adding either potassium bicarbonate or potassium carbonate to a solution of citric acid until effervescence ceases. The resulting solution is then filtered and evaporated to dryness to obtain potassium citrate.

Pharmaceutical Applications

Potassium citrate is used in beverages, foods, and oral pharmaceutical formulations as a buffering and alkalizing agent. It is also used as a sequestering agent and as a therapeutic agent to alkalinize the urine and to relieve the painful irritation caused by cystitis.

Biochem/physiol Actions

Potassium citrate can be used to prepare citrate water that supports the survival of streptozotocin (STZ)-diabetic mice. It might reduce the successive stone formation in calcium nephrolithiasis. Potassium citrate serves as an activator for producing activated carbons.

Safety

Potassium citrate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material by this route of administration. Most potassium citrate safety data relate to its use as a therapeutic agent, for which up to 10 g may be administered daily, in divided doses, as a treatment for cystitis. Although there are adverse effects associated with excessive ingestion of potassium salts, the quantities of potassium citrate used as a pharmaceutical excipient are insignificant in comparison to those used therapeutically. (IV, dog): 0.17 g/kg

storage

Potassium citrate is a stable, though hygroscopic material, and should be stored in an airtight container in a cool, dry place. It is deliquescent in moist air.

Purification Methods

It solubility in H2O is 154% and it loses H2O at 180o. [Beilstein 3 III 1091.]

Incompatibilities

Aqueous potassium citrate solutions are slightly alkaline and will react with acidic substances. Potassium citrate may also precipitate alkaloidal salts from their aqueous or alcoholic solutions. Calcium and strontium salts will cause precipitation of the corresponding citrates. Potassium citrate is incompatible with strong oxidizing agents.

Regulatory Status

GRAS listed. Accepted as a food additive in Europe. Included in the FDA Inactive Ingredients Database (oral solutions and suspensions; topical emulsions and aerosol foams). Included in nonparenteral medicines (cutaneous foams and emulsions; oral liquids, granules, mixtures and soluble tablets; topical liquids, emulsions and mousses) licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

Definition

ChEBI: A hydrate that is the monohydrate form of potassium citrate.

General Description

Potassium citrate tribasic monohydrate (KCTM) is a potassium salt that has been reported to be efficient in forming aqueous two-phase system (ATPS) with UCON 50-HB-5100, a random copolymer. This product is a high quality pharmacopoeia product that meets the testing specifications of USP (United States Pharmacopoeia). It can be employed in research and pilot studies.