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Ethanol | CAS No: 64-17-5 | GMP-certified suppliers
A medication that supports neurolytic procedures to help relieve intractable chronic pain associated with inoperable cancer and trigeminal neuralgia when surgical options are unsuitable.
Therapeutic categories
Primary indications
- For therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (tic douloureux), in patients for whom neurosurgical procedures are contraindicated
Product Snapshot
- This product is supplied primarily as an injectable solution suitable for neurolytic procedures
- It is used for therapeutic neurolysis of nerves or ganglia to address intractable chronic pain associated with conditions such as inoperable cancer and trigeminal neuralgia
- It is approved in the US and Canada
Clinical Overview
Therapeutically, ethanol is approved for neurolytic procedures aimed at relieving intractable chronic pain, including pain associated with inoperable cancer and trigeminal neuralgia when surgical options are unsuitable. Injection near targeted nerves produces controlled chemical neurolysis.
Ethanol’s pharmacodynamic effects arise from its dehydrating and protein-denaturing properties, which confer bactericidal and antifungal activity. At neural sites, ethanol induces neuritis and subsequent axonal degeneration, accounting for its neurolytic use. Ethanol also interacts with multiple neurotransmitter systems by binding to GABA and glycine receptors, inhibiting NMDA receptor function, and modulating acetylcholine and serotonin receptor activity. These actions contribute to its central nervous system depressant effects.
Absorption after oral administration is rapid, with peak concentrations typically occurring within minutes. Ethanol is largely metabolized in the liver, primarily via alcohol dehydrogenase, with 90 to 98 percent oxidized to acetaldehyde and subsequently to acetate. It is a substrate, inducer, or inhibitor of several cytochrome P450 isoenzymes, including CYP2E1, CYP3A, CYP2C9, and CYP2C19, which influences metabolic interactions with co‑administered drugs. Elimination occurs mainly through hepatic metabolism, with a small fraction excreted unchanged in breath, sweat, and urine.
Safety considerations include dose-dependent central nervous system depression, hepatotoxicity with repeated exposure, and local tissue irritation when used for neurolysis. Systemic absorption during interventional use requires careful monitoring.
When sourcing ethanol as an active or functional pharmaceutical ingredient, manufacturers should prioritize material that meets pharmacopeial specifications, includes appropriate impurity controls, and is produced under validated, GMP-compliant processes to ensure suitability for medicinal and interventional applications.
Identification & chemistry
| Generic name | Ethanol |
|---|---|
| Molecule type | Small molecule |
| CAS | 64-17-5 |
| UNII | 3K9958V90M |
| DrugBank ID | DB00898 |
Pharmacology
| Summary | Ethanol produces neurolytic effects by disrupting neuronal membranes and modulating multiple ligand‑gated ion channels, including GABA, glycine, NMDA, acetylcholine, and serotonin receptors. These actions depress excitatory signaling, enhance inhibitory tone, and induce local tissue injury that supports its use in therapeutic nerve destruction for refractory pain. As an anti‑infective, it acts as a dehydrating agent that disrupts cellular osmotic balance and protein structure. |
|---|---|
| Mechanism of action | Ethanol affects the brain’s neurons in several ways. It alters their membranes as well as their ion channels, enzymes, and receptors. Alcohol also binds directly to the receptors for acetylcholine, serotonin, GABA, and the NMDA receptors for glutamate. The sedative effects of ethanol are mediated through binding to GABA receptors and glycine receptors (alpha 1 and alpha 2 subunits). It also inhibits NMDA receptor functioning. In its role as an anti-infective, ethanol acts as an osmolyte or dehydrating agent that disrupts the osmotic balance across cell membranes. |
| Pharmacodynamics | Alcohol produces injury to cells by dehydration and precipitation of the cytoplasm or protoplasm. This accounts for its bacteriocidal and antifungal action. When alcohol is injected in close proximity to nerve tissues, it produces neuritis and nerve degeneration (neurolysis). Ninety to 98% of ethanol that enters the body is completely oxidized. Ethanol is also used as a cosolvent to dissolve many insoluble drugs and to serve as a mild sedative in some medicinal formulations. Ethanol also binds to GABA, glycine, NMDA receptors and modulates their effects. Ethanol is also metabolised by the hepatic enzyme alcohol dehydrogenase. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Gamma-aminobutyric acid receptor subunit alpha-1 | Humans | agonist |
| Glutamate receptor ionotropic, NMDA 3A | Humans | antagonist |
| Glycine receptor subunit alpha-1 | Humans | agonist |
ADME / PK
| Absorption | Rapidly absorbed. |
|---|---|
| Metabolism | Hepatic. Metabolized by cytochrome P450 enzyme CYP2E1. |
Formulation & handling
- Highly volatile, fully water‑miscible small‑molecule solvent used predominantly in topical and parenteral solutions, requiring airtight packaging to limit evaporation.
- Formulations must account for its rapid evaporation, flammability, and ability to alter permeability of co‑formulated actives and excipients.
- Parenteral and ophthalmic uses require strict control of residual water, microbial limits, and container–closure integrity due to its volatility and solvent strength.
Regulatory status
| Lifecycle | The API’s primary U.S. patents expired in 2016, indicating a mature lifecycle with long-standing generic availability. With products marketed in the United States and Canada, the asset is in a stable post‑exclusivity phase across its key markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Ethanol is a mature commodity API with one listed originator‑type manufacturer and numerous packagers supporting broad downstream formulation and distribution. Branded and private‑label products appear mainly in the US and Canada, reflecting established market presence rather than differentiated proprietary versions. All cited US patents have expired, indicating that generic and multi‑source supply is already well established. |
|---|
Safety
| Toxicity | Oral, rat LD<sub>50</sub>: 5628 mg/kg. Symptoms and effects of overdose include nausea, vomiting, CNS depression, acute respiratory failure or death and with chronic use, severe health problems, such as liver and brain damage. |
|---|
- High oral acute toxicity (rat LD50 ~5
- 6 g/kg)
- Overdose is associated with CNS depression, emesis, and risk of respiratory failure
Ethanol is a type of Disinfectants
Disinfectants are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a vital role in maintaining cleanliness and preventing the spread of harmful microorganisms. These chemical agents are designed to eliminate or inhibit the growth of bacteria, viruses, fungi, and other pathogens on various surfaces and objects.
Pharmaceutical-grade disinfectants are formulated to meet stringent quality standards and are commonly used in hospitals, laboratories, pharmaceutical manufacturing facilities, and other healthcare settings. They are also utilized in the food and beverage industry, as well as in households, to ensure proper sanitation and hygiene.
Disinfectants typically contain active ingredients such as quaternary ammonium compounds, chlorine compounds, hydrogen peroxide, or alcohol, which have been proven effective against a broad spectrum of microorganisms. These active ingredients work by disrupting the cell membranes or enzymatic processes of the pathogens, rendering them incapable of replication and causing their eventual destruction.
When selecting a disinfectant, factors such as the intended application, target microorganisms, and compatibility with the surfaces or objects being treated need to be considered. It is crucial to follow proper usage instructions and adhere to recommended contact times for effective disinfection.
In conclusion, disinfectants are essential pharmaceutical APIs used to control and prevent the spread of harmful microorganisms. Their efficacy in eliminating pathogens makes them indispensable in maintaining cleanliness and ensuring public health and safety.
Ethanol (Disinfectants), classified under Antidotes, Deterrents, and Toxicologic Agents
Antidotes, Deterrents, and Toxicologic Agents are an important category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a critical role in healthcare and toxicology. These substances are designed to counteract the effects of poisons, toxins, and overdoses, thereby saving lives and preventing severe health consequences.
Antidotes are substances that neutralize the toxic effects of certain drugs, chemicals, or poisons. They work by either directly binding to the toxic substance or by blocking its harmful actions on the body. Antidotes are administered in emergency situations to quickly reverse the effects of poisoning and restore normal physiological functions.
Deterrents, on the other hand, are pharmaceutical agents used to discourage or prevent harmful behaviors, such as substance abuse. They are designed to make the ingestion or misuse of certain substances unpleasant or less desirable. Deterrents can be formulated to cause unpleasant side effects, such as nausea or vomiting, when a particular substance is consumed in excessive amounts.
Toxicologic agents encompass a broad range of pharmaceutical APIs used in toxicology studies and research. These substances are employed to investigate the toxicity, metabolism, and mechanisms of action of various chemicals and compounds. Toxicologic agents are vital for understanding the potential hazards and risks associated with certain substances, ensuring the safety of drugs, and developing effective treatments for poisoning cases.
In conclusion, Antidotes, Deterrents, and Toxicologic Agents are essential categories of pharmaceutical APIs that address poisoning emergencies, deter harmful behaviors, and enable toxicological research. Their development and availability are crucial for safeguarding public health, enhancing patient care, and advancing our understanding of toxicology.
Ethanol API manufacturers & distributors
Compare qualified Ethanol API suppliers worldwide. We currently have 5 companies offering Ethanol API, with manufacturing taking place in 4 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 |
| Duchefa Farma B.V. | Distributor | Netherlands | Netherlands | CoA, GMP, ISO9001, MSDS | 170 products |
| Euro-Alkohol GmbH | Producer | Germany | Germany | CEP, CoA | 1 products |
| Sigma-Aldrich | Producer | United States | Unknown | CoA, USDMF | 13 products |
| Tereos | Producer | France | France | CoA, Other, GMP, Other, ISO9001 | 6 products |
When sending a request, specify which Ethanol 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 Ethanol 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.
Frequently asked questions about Ethanol API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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