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Excipient monograph · مونوگراف ماده جانبی
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Potassium chloride
پتاسیم کلراید
1Nonproprietary names
- BPPotassium Chloride
- JPPotassium Chloride
- Ph. Eur.Potassium Chloride
- USP–NFPotassium Chloride
2Synonyms and trade names
Chloride of potassium; kalii chloridum; potassium monochloride; sylvite; E508
3Chemical name and CAS Registry Number
Potassium chloride · [7447-40-7]
UNII 660YQ98I10 · PubChem CID 4873
4Empirical formula and molecular weight
KCl · 74.55
5Functional category
Tonicity-adjusting agent
Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Used as a tonicity-adjusting agent in parenteral, ophthalmic and nasal preparations, as an electrolyte component of infusion, dialysis and oral rehydration solutions, and in buffer solutions. A 1.19% w/v aqueous solution is iso-osmotic with serum. It is also used therapeutically for potassium replacement and in foods as a salt substitute.
7Description
Colourless, elongated or cubical crystals, or a white crystalline powder or granules; odourless, with a saline taste.
8Typical properties
- Melting point
- about 770 °C
- Density
- about 1.98 g/cm³
- Solubility
- freely soluble in water (about 1 in 3 at 20 °C); practically insoluble in ethanol and ether
- Iso-osmotic concentration
- 1.19% w/v in water
- pH
- about 7 (neutral aqueous solution)
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place. Aqueous solutions can be sterilised by autoclaving or filtration.
10Incompatibilities
Reacts with silver, lead and mercury salts to form insoluble chlorides. Reacts violently with bromine trifluoride and with a mixture of sulfuric acid and potassium permanganate. Incompatible with strong oxidising agents.
11Method of manufacture
Obtained from naturally occurring minerals such as sylvite, sylvinite and carnallite, or from brines, and purified by recrystallisation.
12Safety
The amounts used as an excipient are of no toxicological concern. Therapeutic oral doses can irritate the gastrointestinal tract, and solid formulations have caused ulceration; hyperkalaemia is a risk in renal impairment. Concentrated solutions must always be diluted before intravenous use, as rapid injection can cause fatal cardiac arrest.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended; the dust may irritate the eyes.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E508). Included in the FDA Inactive Ingredient Database (including intravenous, ophthalmic, nasal and oral preparations) and in parenteral and non-parenteral medicines licensed in Europe.
15Related substances
Potassium bicarbonate; potassium citrate; sodium chloride.
16Comments
Its sodium chloride equivalent is about 0.76, which is used in calculating the amount needed to make a solution isotonic. Concentrated potassium chloride injections are classed as high-alert medicines and must be clearly distinguished from diluted solutions.