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Sevoflurane | CAS No: 28523-86-6 | GMP-certified suppliers
A medication that supports induction and maintenance of general anesthesia for adult and pediatric patients across inpatient and outpatient surgical procedures.
Therapeutic categories
Primary indications
- Sevoflurane is used for the induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery
Product Snapshot
- Sevoflurane is a volatile inhalation anesthetic supplied as a liquid for vaporization
- It is used for induction and maintenance of general anesthesia across inpatient and outpatient surgical settings
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Sevoflurane produces hypnosis, immobility, and muscle relaxation by modifying neuronal excitability. It enhances inhibitory neurotransmission through interactions with GABA A and glycine receptors and reduces excitatory signaling via effects on nicotinic acetylcholine, serotonin, and glutamate receptors. Additional modulation of ionic currents, including hyperpolarization-activated cation, calcium, potassium, and sodium calcium exchange currents, contributes to its anesthetic and cardiovascular effects. Compared with halothane and isoflurane, sevoflurane provides shorter emergence and faster recovery of analgesia.
Absorption occurs rapidly via the pulmonary route, with limited systemic solubility facilitating a predictable anesthetic depth. Metabolism is minimal relative to older inhalational agents and primarily involves CYP2E1, with formation of inorganic fluoride ions and hexafluoroisopropanol. Elimination is largely through exhalation of unchanged drug.
Key safety considerations include dose-dependent respiratory depression, hypotension, QT prolongation, and risk of malignant hyperthermia in susceptible individuals. Elevated fluoride concentrations have been associated with renal injury, particularly under prolonged exposures. Reports of severe bradycardia and cardiac arrest in pediatric patients with Down syndrome require attention to intraoperative monitoring. Neurodevelopmental effects have been noted in animal studies, and caution is advised for repeated or prolonged exposures in young children.
Common clinical brands include formulations used for vaporizer-based delivery systems in anesthesia practice. For API procurement, quality assurance should prioritize control of impurities, confirmation of volatility specifications, and compliance with pharmacopeial standards to ensure consistent performance in inhalation-grade manufacturing.
Identification & chemistry
| Generic name | Sevoflurane |
|---|---|
| Molecule type | Small molecule |
| CAS | 28523-86-6 |
| UNII | 38LVP0K73A |
| DrugBank ID | DB01236 |
Pharmacology
| Summary | Sevoflurane is an inhaled anesthetic that produces general anesthesia primarily by modulating ligand‑gated ion channels, enhancing inhibitory signaling through GABA(A) and glycine receptors and reducing excitatory transmission at nicotinic acetylcholine, serotonin, and glutamate receptors. It also influences multiple cardiac and neuronal ionic currents, contributing to its effects on tissue excitability and muscle relaxation. These combined actions support its use for induction and maintenance of anesthesia across surgical settings. |
|---|---|
| Mechanism of action | The precise mechanism of action of sevoflurane has not been fully elucidated. Like other halogenated inhalational anesthetics, sevoflurane induces anesthesia by binding to ligand-gated ion channels and blocking CNS neurotransmission. It has been suggested that inhaled anesthetics enhance inhibitory postsynaptic channel activity by binding GABA<sub>A</sub> and glycine receptors, and inhibit excitatory synaptic channel activity by binding nicotinic acetylcholine, serotonin, and glutamate receptors.Sevoflurane has an effect on several ionic currents, including the hyperpolarisation-activated cation current (I<sub>f</sub>), the T-type and L-type Ca<sup>2+</sup> currents (I<sub>Ca, T</sub> and I<sub>Ca, L</sub>), the slowly activating delayed rectifier K<sup>+</sup> currents (I<sub>Ks</sub>), and the Na<sup>+</sup>/Ca<sup>2+</sup> exchange current (I<sub>NCX</sub>).This ability to modulate ion channel activity can also regulate cardiac excitability and contractility. |
| Pharmacodynamics | Sevoflurane induces muscle relaxation and reduces sensitivity by altering tissue excitability with a fast onset of action. It does so by decreasing the extent of gap junction-mediated cell-cell coupling and altering the activity of the channels that underlie the action potential.Compared to [halothane] and [isoflurane], sevoflurane has a shorter emergence time, as well as a shorter time to first analgesia.To reach an equilibrium between alveolar and arterial partial pressure, only a minimal amount of sevoflurane needs to be dissolved in blood. The use of sevoflurane can increase the risk of renal injury, respiratory depression, and QT prolongation. Also, it can lead to malignant hyperthermia, perioperative hyperkalemia, and pediatric neurotoxicity. Episodes of severe bradycardia and cardiac arrest have been reported in pediatric patients with Down Syndrome given sevoflurane. Sevoflurane anesthesia may impair the performance of activities requiring mental alertness, such as driving or operating machinery. |
Targets
| Target | Organism | Actions |
|---|---|---|
| GABA(A) Receptor | Humans | agonist |
| Glycine receptor subunit alpha-1 | Humans | agonist |
| Glutamate receptor 1 | Humans | antagonist |
ADME / PK
| Absorption | Sevoflurane is rapidly absorbed into circulation through the lungs; however, solubility in the blood is low (blood/gas partition coefficient at 37°C ranges from 0.63 to 0.69).Therefore, a minimal amount of sevoflurane needs to be dissolved in blood in order to induce anesthesia. |
|---|---|
| Half-life | The terminal elimination half-life of sevoflurane from the peripheral fat compartment is approximately 20 hours. |
| Protein binding | Sevoflurane protein binding has not been evaluated. _In vitro_ analyses have shown that other fluorinated volatile anesthetics can displace drugs from serum and tissue proteins; however, it is unclear if this is clinically significant. Clinical studies have shown that the administration of sevoflurane does not have a significant effect in patients taking drugs that are highly bound and have a small volume of distribution. |
| Metabolism | Sevoflurane is metabolized to hexafluoroisopropanol by cytochrome P450 2E1 in a reaction that promotes the release of inorganic fluoride and carbon dioxide. Hexafluoroisopropanol is rapidly conjugated with glucuronic acid and eliminated in urine. _In vivo_ metabolism studies suggest that approximately 5% of the sevoflurane dose may be metabolized.In most cases, inorganic fluoride reaches its highest concentration within 2 hours of the end of sevoflurane anesthesia, and returns to baseline levels within 48 hours. Sevoflurane metabolism may be induced by chronic exposure to isoniazid and ethanol, and it has been shown that barbiturates do not affect it. |
| Route of elimination | The low solubility of sevoflurane facilitates its rapid elimination through the lungs, where 95% to 98% of this anesthetic is eliminated.Up to 3.5% of the sevoflurane dose appears in urine as inorganic fluoride, and as much as 50% of fluoride clearance is nonrenal (fluoride taken up into bone). |
| Volume of distribution | Patients given low-flow sevoflurane anesthesia during maxillofacial surgery (n=16) had a peripheral volume of distribution of 1634 ml<sub>vapour</sub>/kg<sub>bw</sub> and a total volume of distribution of 1748 ml<sub>vapour</sub>/kg<sub>bw</sub>. |
| Clearance | In patients given low-flow sevoflurane anaesthesia during maxillofacial surgery (n=16), the transport clearance from the central to the peripheral compartment was 13.0 ml<sub>vapour</sub>/kg<sub>bw</sub>⋅min. |
Formulation & handling
- Volatile, non‑aqueous small‑molecule anesthetic supplied as a neat liquid for inhalation; requires vaporizer‑compatible formulation rather than oral or parenteral delivery.
- Low aqueous solubility and high vapor pressure necessitate airtight, chemically inert containers and controlled handling to prevent evaporation and decomposition.
- Formulation stability is influenced by interactions with metal ions and strong Lewis acids, so contact with reactive materials should be avoided during storage and device integration.
Regulatory status
| Lifecycle | Key U.S. patents expired between 2017 and 2018, indicating the API is in a mature post‑exclusivity phase. With availability in the US and Canada, the product now operates in a fully generic, established market environment. |
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| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Sevoflurane is supplied by multiple established manufacturers and packagers, reflecting a mature production landscape in which the original product has long been complemented by additional sources. Branded products are widely available in the US and Canada. With key US patents expiring between 2017 and 2018, the compound is already in a period of established generic competition. |
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Safety
| Toxicity | In the event of sevoflurane overdosage (or what may appear to be overdosage) discontinue administration, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.Patients experiencing an overdose may be at an increased risk of severe adverse effects such as renal injury, respiratory depression, severe bradycardia and cardiac arrest. Fatalities due to sevoflurane abuse have been reported as well.Symptomatic and supportive measures are recommended. Animal studies have shown that the use of anesthetic agents during periods of rapid brain growth or synaptogenesis results in alterations in synaptic morphology and neurogenesis. In primates, anesthetic regimens of up to 3 hours did not increase neuronal cell loss, but regimens of 5 hours or longer did have a significant effect.The oral LD<sub>50</sub> of sevoflurane is 10.8 g/kg in rats and 18.2 g/kg in mice. |
|---|
- High‑dose exposure is associated with renal injury, respiratory depression, severe bradycardia, and risk of cardiac arrest
- Fatalities from misuse have been reported
- Prolonged exposure during periods of rapid neurodevelopment has demonstrated synaptic and neuronal alterations in animal models
Sevoflurane is a type of Inhalation anesthetics
Inhalation anesthetics belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used for inducing general anesthesia. These specialized compounds are administered through inhalation, allowing them to be rapidly absorbed into the bloodstream and exert their anesthetic effects. Inhalation anesthetics are widely utilized in surgical procedures to achieve unconsciousness, analgesia (pain relief), muscle relaxation, and amnesia.
The primary mechanism of action of inhalation anesthetics involves targeting the central nervous system (CNS) and altering neuronal activity. By binding to specific receptors, these anesthetics modulate neurotransmitter release, resulting in the depression of neuronal signaling. This leads to a reversible loss of consciousness and pain sensation, enabling surgeons to perform invasive procedures without causing discomfort or distress to the patient.
Common inhalation anesthetics include volatile liquids such as sevoflurane, desflurane, and isoflurane, as well as nitrous oxide (N2O), which is a gas. These agents possess favorable characteristics, such as rapid onset and offset of action, high potency, and controllable depth of anesthesia. Inhalation anesthetics offer advantages like easy administration, precise dosage titration, and minimal metabolism-related side effects.
The pharmaceutical industry ensures the quality and safety of inhalation anesthetics through rigorous manufacturing processes and strict quality control measures. Stringent regulations are in place to maintain the purity, stability, and efficacy of these APIs. Additionally, continuous research and development efforts aim to improve the pharmacokinetics, safety profiles, and environmental impact of inhalation anesthetics, further enhancing patient care and surgical outcomes.
Sevoflurane (Inhalation anesthetics), classified under Anesthetics
Anesthetics are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the field of medicine. These substances play a vital role in inducing a temporary loss of sensation or consciousness, enabling medical procedures to be performed without pain or discomfort. Anesthetics can be classified into two primary types: general anesthetics and local anesthetics.
General anesthetics act on the central nervous system, producing a reversible loss of consciousness. They are administered through inhalation or injection routes and are commonly employed for major surgeries or procedures that require deep sedation. Examples of general anesthetics include sevoflurane, propofol, and isoflurane.
On the other hand, local anesthetics primarily target a specific region or part of the body, temporarily numbing the area and blocking pain signals. These APIs are frequently used in dental procedures, minor surgeries, and childbirth. Common local anesthetics include lidocaine, bupivacaine, and ropivacaine.
Anesthetics work by interfering with the transmission of nerve signals or by altering the activity of certain receptors in the nervous system. They offer precise control over pain management, allowing medical professionals to perform complex procedures with reduced patient discomfort and anxiety.
The development and manufacturing of anesthetics APIs require stringent quality control measures to ensure safety and efficacy. Pharmaceutical companies adhere to strict regulatory guidelines to produce high-quality APIs. The demand for anesthetics remains consistently high, making this category of APIs a critical component of the pharmaceutical industry.
In conclusion, anesthetics are indispensable pharmaceutical APIs used to induce temporary loss of sensation or consciousness. They can be classified into general and local anesthetics, each serving distinct purposes in medical procedures. The proper development and manufacturing of anesthetics APIs are essential to ensure safe and effective pain management in various healthcare settings.
Sevoflurane API manufacturers & distributors
Compare qualified Sevoflurane API suppliers worldwide. We currently have 5 companies offering Sevoflurane 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 |
|---|---|---|---|---|---|
| Abbvie | Producer | United States | United States | CoA, GMP | 11 products |
| Central Glass | Producer | Japan | Japan | CoA, JDMF | 1 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Shandong N.T. Pharma | Producer | China | China | CEP, CoA, FDA, USDMF, WC | 12 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, ISO9001, MSDS, USDMF | 757 products |
When sending a request, specify which Sevoflurane 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 Sevoflurane 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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