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Edetic acid | CAS No: 60-00-4 | GMP-certified suppliers
A medication that helps reduce blood and tissue lead levels in pediatric and adult patients with acute or chronic lead poisoning, including cases complicated by lead encephalopathy.
Therapeutic categories
Primary indications
- For the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults
Product Snapshot
- Edetic acid is available as injectable concentrates and topical creams or solutions
- It is used as a chelating agent for reducing blood and tissue lead burdens in acute and chronic lead toxicity
- It holds approved status in the United States and Canada, including veterinary approval
Clinical Overview
Clinically, calcium disodium edetate is indicated for reducing circulating and tissue lead levels in acute and chronic lead poisoning, including lead encephalopathy in both pediatric and adult patients. Its role is limited to metals capable of displacing calcium from the chelator; therefore, it is not effective for mercury, gold, or arsenic intoxication due to poor accessibility of these metals in vivo.
Pharmacologically, the calcium in edetate calcium disodium is exchanged for divalent or trivalent metals such as lead, zinc, cadmium, copper, iron, or manganese. The resulting complexes are water soluble and eliminated renally. Although theoretical binding capacity is high, clinical excretion of lead averages only a small fraction of this capacity due to distribution kinetics and tissue compartmentalization. The agent significantly increases urinary zinc loss, while its impact on iron and manganese is minimal.
Absorption is negligible when administered orally, and parenteral delivery is required for therapeutic chelation. Distribution is largely extracellular, and elimination occurs via glomerular filtration without metabolic transformation. Renal function strongly influences clearance, and dose adjustment or avoidance may be required in renal impairment.
Key safety considerations include the potential for nephrotoxicity, electrolyte disturbances, and excessive depletion of essential trace metals, particularly zinc. Careful monitoring of renal parameters and serum minerals is standard during therapy.
Commercially, calcium disodium edetate products are available globally for clinical toxicology use, while edetic acid itself is more common in industrial, laboratory, and formulation settings.
For API procurement, sourcing should prioritize validated manufacturing controls for metal impurity limits, stable polymorphic form where applicable, and compliance with pharmacopeial specifications to ensure chelation performance and safety consistency.
Identification & chemistry
| Generic name | Edetic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 60-00-4 |
| UNII | 9G34HU7RV0 |
| DrugBank ID | DB00974 |
Pharmacology
| Summary | Edetate calcium disodium functions as a chelating agent that forms stable complexes with divalent and trivalent metals capable of displacing its calcium, most notably lead and zinc. Chelation facilitates urinary elimination of these metals, with substantially lower affinity for cadmium, iron, manganese, and copper, and minimal activity against mercury due to its limited bioavailability for binding. Its therapeutic intent is to reduce circulating and stored lead burdens in cases of acute or chronic lead poisoning. |
|---|---|
| Mechanism of action | The pharmacologic effects of edetate calcium disodium are due to the formation of chelates with divalent and trivalent metals. A stable chelate will form with any metal that has the ability to displace calcium from the molecule, a feature shared by lead, zinc, cadmium, manganese, iron and mercury. The amounts of manganese and iron metabolized are not significant. Copper is not mobilized and mercury is unavailable for chelation because it is too tightly bound to body ligands or it is stored in inaccessible body compartments. The excretion of calcium by the body is not increased following intravenous administration of edetate calcium disodium, but the excretion of zinc is considerably increased. |
| Pharmacodynamics | Edetate calcium is a heavy metal chelating agent. The calcium in edetate calcium can be displaced by divalent or trivalent metals to form a stable water soluble complex that can be excreted in the urine. In theory, 1 g of edetate calcium can theoretically bind 620 mg of lead, but in reality only about 5 mg per gram is actually excreted into the urine in lead poisoned patients. In addition to chelating lead, edetate calcium also chelates and eliminates zinc from the body. Edetate calcium also binds cadmium, copper, iron and manganese, but to a much lesser extent than either lead or zinc. Edetate calcium is relatively ineffective for use in treating mercury, gold or arsenic poisoning. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Lead | Humans | chelator |
| Iron | Humans | chelator |
| Manganese cation | Humans | chelator |
ADME / PK
| Absorption | Poorly absorbed from the gastrointestinal tract. Well absorbed following intramuscular injection. |
|---|---|
| Half-life | The half life of edetate calcium disodium is 20 to 60 minutes. |
| Metabolism | Almost none of the compound is metabolized. |
| Route of elimination | It is excreted primarily by the kidney, with about 50% excreted in one hour and over 95% within 24 hours.2 Almost none of the compound is metabolized. |
Formulation & handling
- High aqueous solubility and strong chelating activity support use in aqueous topical and parenteral solutions, with attention to compatibility with metal ions and container materials.
- Intravenous concentrate formulations require control of pH and ionic strength to maintain solubility and prevent precipitation from metal complexation.
- Topical forms (creams, liquids, soaps) should account for its hydrophilic, low‑logP profile, favoring water‑rich systems and minimizing interactions with metal‑containing excipients.
Regulatory status
| Lifecycle | Patent‑expiry details were not provided, so only a general lifecycle statement is possible. In Canada and the US, the API’s lifecycle stage depends on its patent and exclusivity status, but both markets typically see rapid generic entry once protections lapse, indicating that market maturity will hinge on the timing of loss of exclusivity. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The supply landscape for edetic acid is mature, with several established originator‑side manufacturers and a larger group of packagers supporting distribution. Branded and formulated products appear in the US and Canada, indicating a primarily North American commercial presence. Patent protection has long expired, so the market already supports broad generic production and competition. |
|---|
Safety
| Toxicity | Inadvertent administration of 5 times the recommended dose, infused intravenously over a 24 hour period, to an asymptomatic 16 month old patient with a blood lead content of 56 mcg/dl did not cause any ill effects. Edetate calcium disodium can aggravate the symptoms of severe lead poisoning, therefore, most toxic effects (cerebral edema, renal tubular necrosis) appear to be associated with lead poisoning. Because of cerebral edema, a therapeutic dose may be lethal to an adult or a pediatric patient with lead encephalopathy. Higher dosage of edetate calcium disodium may produce a more severe zinc deficiency. |
|---|
- Severe lead poisoning can amplify toxic manifestations
- Reported adverse outcomes include cerebral edema and renal tubular necrosis, independent of direct compound toxicity
- Therapeutic exposures may be hazardous in the presence of lead encephalopathy due to risk of exacerbating cerebral edema
Edetic Acid is a type of Chelating agents
Chelating agents are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a vital role in various medicinal applications. These agents possess a unique ability to form coordination complexes with metal ions, thus facilitating the removal of these ions from biological systems. Chelation is the process of binding metal ions tightly through multiple coordination bonds, forming stable chelates.
Chelating agents find widespread application in pharmaceutical formulations, particularly in the treatment of heavy metal poisoning and metal-related diseases. They act by chelating toxic metal ions, such as lead, mercury, or arsenic, and enhancing their elimination from the body through urine or feces.
In addition to their metal chelation properties, these agents offer several therapeutic benefits. They can improve the bioavailability and stability of pharmaceutical formulations by complexing with metal ions that may otherwise degrade or interact with other compounds in the formulation. Chelation therapy also shows promise in the treatment of certain cardiovascular diseases, as it can help remove calcium deposits from arterial walls.
Commonly used chelating agents in pharmaceuticals include ethylenediaminetetraacetic acid (EDTA), dimercaprol (BAL), and deferoxamine. These agents are carefully selected based on their specific chelating properties and safety profiles.
Overall, chelating agents are indispensable in the pharmaceutical industry due to their ability to effectively bind and remove toxic metal ions from the body. Their diverse applications make them a crucial component in the formulation of medicines, offering therapeutic benefits and improved drug delivery.
Edetic Acid (Chelating agents), classified under Others
The others category refers to pharmaceutical APIs that do not fall under specific classifications such as antibiotics, antivirals, analgesics, or cardiovascular drugs. These APIs are diverse in nature and serve various therapeutic purposes, making them a crucial component of pharmaceutical formulations.
Pharmaceutical companies develop APIs in the others category to address specific medical conditions or target novel biological pathways. This category includes APIs used in oncology, neurology, immunology, and other specialized areas of medicine. The APIs in this category are often designed to interact with specific molecular targets or receptors, providing targeted therapeutic effects.
The development of APIs in the others category requires extensive research and testing to ensure their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers employ advanced techniques such as chemical synthesis, biotechnology, and genetic engineering to produce these APIs.
Due to the broad range of applications and therapeutic uses, APIs in the others category contribute significantly to the advancement of medical treatments. Pharmaceutical companies constantly strive to innovate and discover new APIs within this category to address unmet medical needs and improve patient outcomes.
In conclusion, the others category of pharmaceutical APIs encompasses a diverse range of active ingredients used in drug formulation. These APIs play a crucial role in developing innovative therapies across various therapeutic areas, contributing to advancements in healthcare and patient well-being.
Edetic Acid API manufacturers & distributors
Compare qualified Edetic Acid API suppliers worldwide. We currently have 3 companies offering Edetic Acid API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CoA, GMP, MSDS | 176 products |
| DNS Fine Chemicals | Producer | India | India | CoA | 8 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Netherlands | CoA, GMP, ISO9001, MSDS | 170 products |
When sending a request, specify which Edetic Acid 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.).
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Regulatory
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