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Potassium bicarbonate | CAS No: 298-14-6 | GMP-certified suppliers
A medication that neutralizes gastric acid and replenishes potassium to support electrolyte balance and gastrointestinal comfort in patients requiring antacid and potassium supplementation.
Therapeutic categories
Primary indications
- Potassium bicarbonate is used as an antacid, electrolyte replenisher and potassium supplement
- It can also be used as an excipient in drug formulations
- An antacid is a medication used to neutralize gastric acid in a short timeframe after ingestion and the effect is soon overcome by meal-stimulated acid secretion
Product Snapshot
- Potassium bicarbonate is available as an oral small molecule in multiple formulations including tablets, capsules, suspensions, and powders
- It is primarily utilized as an antacid, electrolyte replenisher, and potassium supplement, and also serves as an excipient in pharmaceutical formulations
- The compound is approved for use in major regulatory markets including the US, Canada, and the EU
Clinical Overview
Pharmacologically, potassium bicarbonate belongs to the class of organic carbonic acids. Its antacid effect is achieved by neutralizing gastric hydrochloric acid, thereby increasing the pH of the gastrointestinal environment. This elevation in pH results in decreased activity of pepsin, a proteolytic enzyme that contributes to mucosal ulceration in the presence of acid. Potassium, the principal intracellular cation, plays a crucial role in maintaining nerve impulse conduction, renal function, acid-base balance, and cellular metabolism. The bicarbonate component contributes to the generation of carbon dioxide, which may cause eructation, a known side effect in some patients.
Absorption and elimination characteristics are consistent with its ionic nature. Potassium bicarbonate is mainly renally excreted, and its systemic potassium levels must be monitored to avoid hyperkalemia, particularly in patients with impaired renal function or those receiving concomitant medications that alter potassium balance.
Potassium bicarbonate is incorporated not only as an active pharmaceutical ingredient but also as an excipient in various drug formulations. Its clinical use is aligned with conditions requiring rapid neutralization of gastric acidity and potassium supplementation.
From a sourcing perspective, high purity and compliance with pharmacopeial standards are essential. The API should be procured from suppliers with validated manufacturing processes ensuring consistent crystalline form and minimal impurities. Attention to stability, especially moisture control, is critical to maintain product quality during storage and formulation.
Identification & chemistry
| Generic name | Potassium bicarbonate |
|---|---|
| Molecule type | Small molecule |
| CAS | 298-14-6 |
| UNII | HM5Z15LEBN |
| DrugBank ID | DB11098 |
Pharmacology
| Summary | Potassium bicarbonate acts primarily as an antacid by neutralizing gastric hydrochloric acid, thereby increasing gastrointestinal pH and inhibiting pepsin activity. It serves as a source of potassium ions, essential for maintaining nerve impulse conduction, acid-base balance, and cellular function across multiple tissues. The compound also releases CO2 during its neutralization process, which can lead to gastrointestinal gas formation. |
|---|---|
| Mechanism of action | The antacid potential of potassium bicarbonate is attained by increasing the gastrointestinal pH by neutralizing hydrochloric acid. The increase in pH results in suppression of the action of pepsin which is the enzyme that exacerbates ulceration due to the presence of acid. |
| Pharmacodynamics | Potassium is the principal intracellular cation in most body tissues. The concentration of potassium ions is essential to conduct nerve impulses in specialized tissues like brain, heart and skeletal muscle, as well as to maintain normal renal function, acid-base balance, and cellular metabolic functions. The use of compounds containing bicarbonate is showed to produce the release of CO2. This effect has been one of the problems of the use of potassium bicarbonate as it can cause eructation. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Hydrogen ions | neutralizer |
ADME / PK
| Absorption | Potassium bicarbonate intake is done mainly in the small intestine in which approximately 90% of the potassium will be absorbed by passive diffusion. |
|---|---|
| Half-life | Some reports have shown that after absorption, most body potassium exchanges rapidly with a half-life of less than 7 hours. |
| Route of elimination | Approximately 90% of the exogenous potassium consumed is lost in the urine while the other 10% is excreted in feces and a very small amount can be found in the sweat. The excreted potassium is freely filtered by the glomerulus of the kidney. |
Formulation & handling
- Potassium bicarbonate is a small molecule API intended for oral administration in various solid and liquid dosage forms, including effervescent tablets and suspensions.
- The API is highly water-soluble and should be formulated to ensure proper dissolution, particularly for effervescent and solution-based presentations.
- Caution is advised regarding potassium content in the diet and excipients to avoid hyperkalemia; formulations should consider compatibility with food and instructions to take with a full glass of liquid.
Regulatory status
| Lifecycle | The API is in a mature lifecycle phase with patent protections expired in the US, Canada, and the EU, allowing for widespread generic availability across these markets. Market activity is primarily focused on generic manufacturing and distribution. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for potassium bicarbonate includes multiple originator companies producing branded products such as Alka-Seltzer Gold and BasoSAN, with market presence across the US, Canada, and the EU. The availability of several branded products suggests a competitive environment, while the absence of patent expiry information indicates that generic competition may already be present or emerging in these regions. |
|---|
Safety
| Toxicity | Potassium bicarbonate does not contain any toxic chemicals and it is not listed as a carcinogenic or a potential carcinogen. Potassium bicarbonate is also considered safe in pregnancy as the current data do not suggest a teratogenic potential or any developmental toxicity. |
|---|
- Potassium bicarbonate is not classified as a carcinogen or potential carcinogen
- Current data do not indicate teratogenicity or developmental toxicity
- Handling should consider its role as an electrolyte to prevent imbalance upon exposure
Potassium hydrogen carbonate is a type of Electrolytes
Electrolytes are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) that play a vital role in maintaining the balance of essential ions in the body. These ions include sodium, potassium, calcium, magnesium, and chloride, among others. Electrolytes are responsible for maintaining proper hydration, regulating nerve and muscle function, and supporting various physiological processes.
In the pharmaceutical industry, electrolytes are widely utilized in the formulation of oral rehydration solutions, intravenous fluids, and dialysis solutions. These medications are employed to treat conditions such as dehydration, electrolyte imbalances, and renal dysfunction.
The availability of high-quality electrolyte APIs is of utmost importance to ensure the efficacy and safety of these pharmaceutical products. Pharmaceutical manufacturers rely on reputable suppliers who adhere to stringent quality control measures and comply with Good Manufacturing Practices (GMP) to produce electrolyte APIs of consistent quality.
To meet regulatory requirements, electrolyte APIs undergo rigorous testing to confirm their identity, purity, and potency. This includes analysis using advanced techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and atomic absorption spectroscopy (AAS).
In conclusion, electrolytes are a vital category of pharmaceutical APIs used to maintain the balance of essential ions in the body. They are extensively employed in various medications aimed at treating dehydration, electrolyte imbalances, and renal dysfunction. Pharmaceutical manufacturers prioritize the use of high-quality electrolyte APIs to ensure the safety and efficacy of their products, and adherence to stringent regulatory standards is crucial in their production and testing processes.
Potassium hydrogen carbonate API manufacturers & distributors
Compare qualified Potassium hydrogen carbonate API suppliers worldwide. We currently have 2 companies offering Potassium hydrogen carbonate API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Sanofi | Producer | France | France | CoA, GMP | 93 products |
When sending a request, specify which Potassium hydrogen carbonate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Potassium hydrogen carbonate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
