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Propofol | CAS No: 2078-54-8 | GMP-certified suppliers
A medication that supports rapid induction and maintenance of anesthesia and provides a controlled sedation option for managing refractory status epilepticus in critical care settings.
Therapeutic categories
Primary indications
- Used for induction and/or maintenance of anaesthesia and for management of refractory status epilepticus
Product Snapshot
- Propofol is supplied as an intravenous injectable emulsion for parenteral use
- It is used for anaesthesia induction and maintenance and for managing refractory status epilepticus in controlled settings
- It holds approvals in the US and Canada with human, investigational, and veterinary regulatory statuses
Clinical Overview
Its clinical effect reflects fast CNS penetration, producing hypnosis typically within 40 seconds, consistent with one arm–brain circulation time. Propofol acts primarily through positive allosteric modulation of GABA‑A receptors, enhancing inhibitory neurotransmission. This mechanism leads to dose‑dependent sedation, hypnosis, and reduction of cerebral metabolic rate.
Absorption is immediate with IV use. Distribution is characterized by rapid redistribution from the central compartment, contributing to short recovery times. Propofol is extensively metabolized in the liver via glucuronidation and hydroxylation pathways, involving UGT1A1, UGT1A6, UGT1A9, and CYP2B6, CYP2C9, and CYP2C19. The metabolites are largely inactive and eliminated renally. Propofol exhibits high plasma protein binding and a relatively large volume of distribution.
Notable safety considerations include risks of hypotension, respiratory depression, and rare but serious propofol infusion syndrome during prolonged high‑dose administration, characterized by metabolic acidosis, rhabdomyolysis, and cardiac dysfunction. QTc effects have been reported in susceptible populations. Use in refractory status epilepticus requires monitoring for hemodynamic instability. Pain on injection is common, typically mitigated by lidocaine co‑administration or larger‑vein access. Propofol should only be administered by trained personnel with airway management capability.
Propofol is supplied worldwide in lipid emulsion formulations; brand examples include Diprivan, though many generic preparations exist.
For API sourcing, manufacturers should verify compliance with pharmacopeial monographs, ensure control of oxidative degradation pathways, and confirm suitability for sterile formulation processes. Robust impurity profiling and validated stability data are essential for regulatory submissions.
Identification & chemistry
| Generic name | Propofol |
|---|---|
| Molecule type | Small molecule |
| CAS | 2078-54-8 |
| UNII | YI7VU623SF |
| DrugBank ID | DB00818 |
Pharmacology
| Summary | Propofol enhances inhibitory neurotransmission by positively modulating GABA‑A receptor activity, primarily through beta‑2 and beta‑3 subunits. This interaction produces rapid hypnotic and sedative effects consistent with its use in anesthesia and in managing refractory status epilepticus. Additional activity at selected sodium channel subtypes may contribute to its overall CNS‑depressant profile. |
|---|---|
| Mechanism of action | The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors. |
| Pharmacodynamics | Propofol is a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly with minimal excitation, usually within 40 seconds from the start of an injection (the time for one arm-brain circulation). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Gamma-aminobutyric acid receptor subunit beta-2 | Humans | potentiator |
| Gamma-aminobutyric acid receptor subunit beta-3 | Humans | potentiator |
| GABA(A) Receptor | Humans | positive allosteric modulator |
ADME / PK
| Absorption | Rapid - time to onset of unconsciousness is 15-30 seconds, due to rapid distribution from plasma to the CNS. Distribution is so rapid that peak plasma concentrations cannot be readily measured. Duration of action is 5-10 minutes. |
|---|---|
| Half-life | Initial distribution phase t<sub>1/2α</sub>=1.8-9.5 minutes. Second redistirubtion phase t<sub>1/2β</sub>=21-70 minutes. Terminal elimination phase t<sub>1/2γ</sub>=1.5-31 hours. |
| Protein binding | 95 to 99%, primarily to serum albumin and hemoglobin |
| Metabolism | Hepatically metabolized mainly by glucuronidation at the C1-hydroxyl. Hydroxylation of the benzene ring to 4-hydroxypropofol may also occur via CYP2B6 and 2C9 with subsequent conjugation to sulfuric and/or glucuronic acid. Hydroxypropofol has approximately 1/3 of hypnotic activity of propofol. |
| Route of elimination | It is chiefly eliminated by hepatic conjugation to inactive metabolites which are excreted by the kidney. |
| Volume of distribution | * 60 L/kg [healthy adults] |
| Clearance | * 23 - 50 mL/kg/min * 1.6 - 3.4 L/min [70 Kg adults] |
Formulation & handling
- Propofol is a highly lipophilic small molecule requiring intravenous delivery, formulated as an oil‑in‑water emulsion due to very low aqueous solubility.
- The emulsion system demands strict microbial control and limited hang time because it supports microbial growth and is sensitive to oxidation.
- Handling typically requires protection from light and avoidance of excessive agitation to maintain emulsion integrity and prevent phase separation.
Regulatory status
| Lifecycle | Most Canadian protection lapsed in 2015, indicating a mature and fully generic market, while U.S. exclusivity largely ended the same year except for a remaining patent expiring in mid‑2025. Overall, the product is in a late lifecycle phase across both markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Propofol is supplied by multiple manufacturers and packagers, indicating a mature market with no single originator dominating current production. Branded and unbranded versions are established in the US and Canada, reflecting broad regional availability. Most listed patents have expired, with one remaining US patent ending in 2025, supporting the presence of existing generic competition and potential for further entrants. |
|---|
Safety
| Toxicity | Overdosage may increase pharmacologic and adverse effects or cause death. <p>IV LD<sub>50</sub>=53 mg/kg (mice), 42 mg/kg (rats). Oral LD<sub>50</sub> (as a solution in soybean oil)=1230 mg/kg (mice), 600 mg/kg (rats)</p> |
|---|
- High acute toxicity demonstrated by low IV LD50 values in rodents
- Limit exposure to prevent pharmacologic CNS‑depressant effects and potential lethal outcomes
- Oral and parenteral toxicity profiles indicate a need for controlled handling conditions to avoid accidental ingestion or injection during manufacturing or formulation steps
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Propofol is a type of Intravenous anesthetics
Intravenous anesthetics are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in medical procedures that require general anesthesia. These potent compounds are administered intravenously to induce a controlled state of unconsciousness, allowing patients to undergo surgeries or other invasive procedures without pain or discomfort.
One of the primary benefits of intravenous anesthetics is their rapid onset of action. These APIs quickly enter the bloodstream upon injection, facilitating a swift and predictable induction of anesthesia. Additionally, their potency allows for precise control of the depth of anesthesia, ensuring patient safety throughout the procedure.
Commonly used intravenous anesthetics include propofol, etomidate, and barbiturates. Propofol, for instance, is a short-acting agent that offers smooth and rapid induction and recovery, making it ideal for outpatient surgeries. Etomidate, on the other hand, provides hemodynamic stability and is commonly used in patients with cardiovascular conditions.
The use of intravenous anesthetics requires expertise and careful monitoring due to their potential side effects, such as respiratory depression and cardiovascular instability. However, their controlled and reversible nature allows for a tailored anesthesia experience, minimizing the risk of complications and ensuring patient comfort.
In summary, intravenous anesthetics are crucial pharmaceutical APIs used in anesthesia practice. Their rapid onset, precise control, and reversible effects make them essential tools for anesthesiologists, enabling safe and effective management of patients undergoing various medical procedures.
Propofol (Intravenous 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.
Propofol API manufacturers & distributors
Compare qualified Propofol API suppliers worldwide. We currently have 10 companies offering Propofol API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Dongkook Pharma | Producer | South Korea | South Korea | CoA, JDMF | 6 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Euticals | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 48 products |
| Harman Finochem | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF | 34 products |
| Porton Fine Chem. | Producer | China | China | CEP, CoA | 4 products |
| SI Group | Producer | United States | United States | CEP, CoA, FDA, USDMF | 2 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF, WC | 757 products |
| Solfyn International LLP | Distributor | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 24 products |
| Yangtze River Pharmaceuti... | Producer | China | China | CoA, FDA, GMP, ISO14001 | 34 products |
When sending a request, specify which Propofol 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 Propofol 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 Propofol API
Sourcing
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Technical
What is Propofol (CAS 2078-54-8) used for?
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Regulatory
Where is Propofol approved or in use globally?
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Pharmaoffer
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