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Sodium citrate | CAS No: 68-04-2 | GMP-certified suppliers
A medication that supports anticoagulation in blood processing procedures and helps neutralize gastric and urinary acidity for managing related metabolic and discomfort conditions.
Therapeutic categories
Primary indications
- Used as an anticoagulant during plasmophoresis as well as a neutralizing agent in the treatment of upset stomach and acidic urine [FDA Label]
Product Snapshot
- Sodium citrate is available as an oral and injectable small‑molecule excipient/agent supplied in multiple solution, powder‑for‑solution, and liquid formats
- It is used as an anticoagulant in extracorporeal procedures and as a neutralizing agent for gastric acidity and acidic urine
- It is approved in the US, EU, and Canada, with some presentations listed as investigational
Clinical Overview
Pharmacologically, sodium citrate acts through two principal pathways. When administered in blood processing or extracorporeal circuits, the citrate ion chelates ionized calcium, an essential cofactor in the extrinsic coagulation cascade. By forming calcium–citrate complexes, it reduces the availability of free calcium needed for activation of coagulation factor X via the tissue factor and factor VIIa complex. This effectively suppresses initiation of coagulation during blood handling. Some anticoagulant activity persists even after calcium repletion, suggesting additional mechanisms that are not fully characterized.
In the gastrointestinal tract, sodium citrate behaves as a weak base, reacting with gastric hydrochloric acid to raise luminal pH. Following absorption, citrate is metabolized to bicarbonate, contributing to systemic alkalinization and increasing urinary pH. Enhanced urinary alkalinity may promote calciuresis and can support management of conditions associated with acidic urine.
Absorption is rapid after oral administration, and metabolism occurs primarily via oxidative pathways to yield bicarbonate. Distribution and elimination parameters are not clinically emphasized because the compound is extensively metabolized to endogenous intermediates.
Safety considerations include the risk of metabolic alkalosis, hypernatremia, and fluid overload in susceptible patients. In anticoagulant use, excessive citrate exposure may cause hypocalcemia, manifesting as neuromuscular irritability or hypotension. Use in individuals with impaired renal function requires caution due to reduced bicarbonate clearance.
Common usage contexts include oral alkalinizing solutions, anticoagulant citrate solutions for apheresis, and components of buffer or irrigation formulations.
For API procurement, suppliers should provide material meeting compendial specifications for identity, purity, and inorganic impurities, with consistent control of hydration state and particle characteristics relevant to formulation performance.
Identification & chemistry
| Generic name | Sodium citrate |
|---|---|
| Molecule type | Small molecule |
| CAS | 68-04-2 |
| UNII | RS7A450LGA |
| DrugBank ID | DB09154 |
Pharmacology
| Summary | Citrate acts primarily by chelating ionized calcium, blocking calcium‑dependent steps in the extrinsic coagulation pathway and reducing activation of factor X. It also neutralizes gastric and systemic acidity through conversion to bicarbonate, increasing pH in the stomach, blood, and urine. Additional effects include increased urinary calcium excretion. |
|---|---|
| Mechanism of action | Citrate chelates free calcium ions preventing them from forming a complex with tissue factor and coagulation factor VIIa to promote the activation of coagulation factor X . This inhibits the extrinsic initiation of the coagulation cascade. Citrate may also exert an anticoagulant effect via a so far unknown mechanism as restoration of calcium concentration does not fully reverse the effect of citrate . Citrate is a weak base and so reacts with hydrochloric acid in the stomach to raise the pH. It it further metabolized to bicarbonate which then acts as a systemic alkalizing agent, raising the pH of the blood and urine . It also acts as a diuretic and increases the urinary excretion of calcium. |
| Pharmacodynamics | Citrate prevents activation of the clotting cascade by chelating calcium ions. Citrate neutralizes acid in the stomach and urine, raising the pH . |
ADME / PK
| Absorption | Tmax of 98-130min . |
|---|---|
| Half-life | 18-54 min |
| Metabolism | Citrate is metabolized to bicarbonate in the liver and plays a role as an intermediate in the citric acid cycle . |
| Route of elimination | Largely eliminated through hepatic metabolism with very little cleared by the kidneys . |
| Volume of distribution | 19-39L . |
| Clearance | Total clearance of 313-1107mL/min . |
Formulation & handling
- Highly water‑soluble small‑molecule excipient/anticoagulant commonly formulated as aqueous solutions for IV, extracorporeal, ophthalmic, irrigation, and rectal use, with straightforward dissolution and minimal solubilization constraints.
- Oral products (powders, solutions, effervescent forms) present no notable food‑related restrictions and rely on simple aqueous dissolution, with pH‑buffering effects influencing excipient selection and taste‑masking needs.
- Solid raw material is stable and easy to handle, but finished solutions require control of pH and ionic strength to maintain compatibility with devices, biologics, and ocular or parenteral tissues.
Regulatory status
| Lifecycle | Patent‑expiry information was not provided, so a full lifecycle assessment cannot be completed. Based solely on availability in Canada, the US, and the EU, the API appears to be in a mature, globally established phase with broad post‑launch market presence. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Sodium citrate is an established anticoagulant and buffering agent supplied by multiple originator and long‑standing manufacturers, with no single company dominating global production. Branded presentations such as A‑C‑D and ACD Blood‑Pack units are available across the US, EU, and Canada, indicating broad market penetration supported by mature production networks. Patent protection for this compound has long expired, so generic competition is well‑established and manufacturing is typically commodity‑based. |
|---|
Safety
| Toxicity | Overdose toxicity is mainly due to alkalosis as well as tetany or depressed heart function due to lack of free calcium . |
|---|
- Overexposure can induce systemic alkalosis and calcium‑binding effects, which may precipitate tetany or depress cardiac function
- Product handling should account for its potential to reduce free ionized calcium in biological systems
- Processes involving elevated concentrations may require controls to limit pH shift–related hazards
Sodium Citrate is a type of Anticoagulant proteins
Anticoagulant proteins are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a vital role in preventing the formation of blood clots. These proteins are naturally occurring substances that interfere with the clotting cascade, a complex series of reactions that lead to blood coagulation.
One of the well-known anticoagulant proteins is hirudin, derived from leeches. Hirudin acts by inhibiting thrombin, a key enzyme involved in blood clot formation. Another notable anticoagulant protein is antithrombin III, which blocks several clotting factors, including thrombin and factors IXa, Xa, XIa, and XIIa. These proteins are widely used in the pharmaceutical industry to develop medications for conditions such as deep vein thrombosis, pulmonary embolism, and stroke prevention.
The production of anticoagulant proteins involves advanced biotechnological processes. Recombinant DNA technology and genetic engineering techniques are employed to produce these proteins in large quantities. The proteins are expressed in host organisms such as bacteria, yeast, or mammalian cells, and then purified through various chromatographic and filtration steps to obtain a highly pure and active form.
The development of anticoagulant proteins has significantly improved the treatment and management of thrombotic disorders. These APIs have proven to be effective in preventing clot formation, reducing the risk of life-threatening complications. However, it is crucial to administer anticoagulant proteins under medical supervision due to their potential side effects and the need for precise dosing.
In conclusion, anticoagulant proteins are a vital subcategory of pharmaceutical APIs that act by inhibiting key components of the clotting cascade. Their production involves advanced biotechnological processes, and they have greatly enhanced the management of thrombotic disorders. Proper medical guidance is essential for their safe and effective use.
Sodium Citrate (Anticoagulant proteins), classified under Anticoagulants
Anticoagulants are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to prevent and treat blood clotting disorders. These medications play a crucial role in various medical conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF). Anticoagulants work by inhibiting the formation of blood clots or by preventing existing clots from getting larger.
There are different types of anticoagulants available, including direct thrombin inhibitors, vitamin K antagonists, and factor Xa inhibitors. Direct thrombin inhibitors, such as dabigatran, directly target the enzyme thrombin to hinder clot formation. Vitamin K antagonists, like warfarin, interfere with the production of clotting factors that rely on vitamin K. Factor Xa inhibitors, such as rivaroxaban and apixaban, inhibit the activity of factor Xa, a crucial component in the clotting cascade.
Anticoagulants are commonly prescribed to patients at risk of developing blood clots or those with existing clotting disorders. They are often used during surgeries, such as hip or knee replacements, to minimize the risk of post-operative clot formation. Patients with AF, a condition characterized by irregular heart rhythm, may also be prescribed anticoagulants to prevent stroke caused by blood clots.
While anticoagulants offer significant benefits in preventing and treating clot-related conditions, they also carry potential risks, including bleeding complications. Patients taking anticoagulants require careful monitoring to ensure the right dosage is administered, as excessive anticoagulation can lead to hemorrhage. Regular blood tests and close medical supervision are essential to manage the delicate balance between preventing clots and avoiding excessive bleeding.
In conclusion, anticoagulants are a crucial category of pharmaceutical APIs used to prevent and treat blood clotting disorders. They function by inhibiting clot formation or preventing existing clots from enlarging. While highly beneficial, their use requires careful monitoring to minimize the risk of bleeding complications.
Sodium Citrate API manufacturers & distributors
Compare qualified Sodium Citrate API suppliers worldwide. We currently have 7 companies offering Sodium Citrate API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | BSE/TSE, CoA, GMP, ISO9001, MSDS | 170 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Komatsuya Corporation | Producer | Japan | Japan | CoA, JDMF | 2 products |
| Showa Kako Corp | Producer | Japan | Japan | CoA, JDMF | 2 products |
When sending a request, specify which Sodium Citrate 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 Sodium Citrate 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.
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