| HS Code | 973792 |
| Chemical Name | 2,6-Diisopropylphenol |
| Cas Number | 2078-54-8 |
| Molecular Formula | C12H18O |
| Molecular Weight | 178.27 g/mol |
| Appearance | Clear colorless to slightly yellowish viscous liquid |
| Solubility | Practically insoluble in water; soluble in ethanol, acetone, chloroform, and lipid vehicles |
| Melting Point | 18 °C |
| Boiling Point | 256 °C |
| Density | 0.962 g/cm3 at 20 °C |
| Pka | 11.0 |
| Logp | 3.79 |
| Storage Conditions | Keep tightly closed, protected from light, in a cool place under inert gas |
| Stability | Sensitive to air and light; oxidation can occur if improperly stored |
| Assay | 98.0% to 102.0% on anhydrous basis |
| Refractive Index | 1.520 at 20 °C |
As an accredited Propofol Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Propofol Veterinary Grade API is packed in sealed, light-protected containers with tamper-evident closures, supplied as 25 kg per drum for stability. |
| Container Loading (20′ FCL) | One 20-foot FCL containing palletized, securely packed drums/cartons of Propofol Veterinary Grade API, ready for safe transport and storage. |
| Shipping | Propofol Veterinary Grade API requires temperature-controlled, light-protected shipping to maintain stability. Pack in sealed, inert containers with absorbents; label as pharmaceutical API. Use qualified cold-chain couriers for international/domestic transport. Include MSDS and handling documentation. Avoid excessive vibration or freezing, and ensure prompt release at destination. |
| Storage | Store Propofol Veterinary Grade API in a cool, dry, well-ventilated area, ideally between 15–25°C, protected from light, moisture, and oxygen. Keep the container tightly sealed when not in use. Avoid heat, sparks, and incompatible materials. For formulated products, follow specific labeled storage guidance to maintain stability and sterility. |
| Shelf Life | Shelf life is 24 months when stored as directed, in sealed containers, protected from light and moisture. |
An application for propofol veterinary grade API that carries downstream processing obligations is the manufacture of sterile lipid injectable emulsions for intravenous induction in dogs and cats. Propofol is poorly water-soluble, with an aqueous solubility of less than 0.15 mg/mL at 25°C and a log P of approximately 3.8, so the API is dissolved in a soybean oil phase rather than an aqueous vehicle. For manufacturers, a propofol oil-phase stock solution in refined soybean oil at a concentration of 10 mg/mL is a true solution but not a finished dosage form; it becomes an injectable only after addition of the aqueous phase and high-pressure homogenization with lecithin. The oil phase is heated to 60–70°C and mixed with egg lecithin under low-shear agitation before being combined with an aqueous phase containing glycerol and disodium edetate; subsequent rotor-stator homogenization at 8,000–12,000 rpm produces a coarse pre-emulsion that is passed through a microfluidizer at 10,000–15,000 psi. Terminal autoclaving at 121°C for 15 min is used because a sterilising-grade 0.22 µm filter would retain the emulsion droplets and destroy the product. The filled vial is a Type I borosilicate glass container sealed with a bromobutyl stopper and aluminium cap. Mean droplet diameter is controlled to below 500 nm under USP <729>, and the PFAT5 value is maintained below 0.05%; any rise above this threshold indicates coalescence that can produce pulmonary embolism in small-breed dogs. Filling is performed in a classified cleanroom environment under EU GMP Annex 1 for a terminally sterilised product, and each batch is tested for sterility by USP <71> and bacterial endotoxins by USP <85>. Because the emulsion contains no antimicrobial preservative, opened vials are treated as single-use and residual contents are discarded within 6 h after needle access in veterinary hospital practice; this is an operational boundary that every downstream purchasing specification must state.
Equine field anesthesia protocols use propofol as an IV induction agent and as a constant-rate infusion in non-food horses. The clinical application is not limited by the API’s hypnotic potency but by emulsion stability in disposable syringe drivers and long extension sets. Syringe drivers should have a mechanical accuracy of at least ±2% at low infusion rates because maintenance doses of 0.2–0.3 mg/kg/min require precise flow control in a 500 kg horse; a 50 mL or 60 mL syringe filled from a freshly spiked vial is connected through a low dead-volume extension set with a priming volume below 0.5 mL to reduce delayed delivery when switching from induction to maintenance. Free fatty acid release from hydrolysed egg lecithin is accelerated by extended dwell time at ambient operating theatre temperatures; therefore infusion syringes prepared for total intravenous anesthesia should not be held beyond 6 h, and any visual creaming or oiling is treated as a batch failure. Cardiorespiratory monitoring during equine total intravenous anesthesia includes invasive arterial pressure for true hypotension detection because propofol causes dose-dependent decreases in systemic vascular resistance; published dose schedules for propofol induction in horses typically fall in the range of 2–2.5 mg/kg after alpha-2 agonist premedication, with maintenance infusions of 0.2–0.3 mg/kg/min adjusted to surgical stimulus. Horses have a documented risk of excitement or paddling if the emulsion is administered too rapidly or if environmental noise is high; this is an application-specific failure mode not observed with thiopental at equivalent depths. Feed-producing horses intended for human consumption must be excluded under residue safety rules.
In porcine, bovine, ovine, caprine and poultry production, the application assessment ends at regulatory residue safety, not formulation viscosity or premix homogeneity. No maximum residue limit has been established for propofol in edible tissues under Commission Regulation (EU) No 37/2010, and the compound is not approved by the US FDA for use in food-producing animals. A premix, oral powder, granule, tablet, capsule or drinking-water solution intended for swine, cattle, sheep, goats, poultry or farmed fish therefore lacks the residue safety basis required under Regulation (EU) 2019/6 or 21 CFR 530.41 for extralabel use. Even if a manufacturer can physically adsorb propofol onto a carrier to form a free-flowing powder, that manufacturing achievement is irrelevant to market access because the risk assessment for human consumption of residual propofol has not been completed. The operational boundary is absolute: do not assign propofol API batches to feed premix or oral dosage projects for food-producing animals. In equine practice, the same restriction applies to horses that have entered the food chain; a permanent veterinary record of non-food status is required before total intravenous anesthesia or interval induction is performed. This segment is intentionally brief because the application is closed by regulatory incompatibility rather than formulation physics.
Propofol is a hindered phenolic liquid at ambient temperature; its melting point is 19°C, and its neat API viscosity is high enough that direct compression with microcrystalline cellulose or lactose is not a predictable unit operation. Tablet and capsule projects therefore require either liquid-fill hard capsules using a gel-sealed band or adsorption of the liquid propofol onto a solid carrier such as colloidal silicon dioxide, calcium silicate, or silicified microcrystalline cellulose before blending with a filler and lubricant. The adsorption step must be performed under nitrogen to limit oxidative discoloration, and the carrier-to-API ratio is usually determined by the oil absorption number of the selected silicate; if the ratio is insufficient, the blend becomes sticky and will fail die-filling during compression. No registered oral propofol tablet or capsule exists in the EU or US veterinary markets, and oral administration in dogs is known to exhibit negligible systemic bioavailability because of extensive first-pass hepatic clearance by glucuronidation and hydroxylation. A request for propofol granules or oral powder should therefore be classified as a non-standard compounded or laboratory research presentation; the manufacturer must verify that the recipient does not intend food-producing species and that the formulation is not promoted as a therapeutic oral veterinary product. Published data for this specific configuration is limited, and any stability claim for an oral propofol powder must be generated on a batch-specific basis under ICH climate condition 25°C/60% RH and 40°C/75% RH rather than extrapolated from injectable emulsion stability.
Because laboratory animal anesthesia requires intravenous access and strict aseptic technique, propofol veterinary grade API is used only as a sterile injectable emulsion, not as an oral solution or suspension. Propofol is administered to rabbits, ferrets, and non-human primates for short, recoverable procedures; in small rodents, tail-vein cannulation limits routine use, and the compound is not suitable for intraperitoneal depot administration because the lipid vehicle delays absorption unpredictably. The emulsion is drawn into an ISO 7886-1 sterile single-use syringe and delivered through an extension set with a priming volume below 0.5 mL; accidental bolus delivery from a high dead-volume line can exceed the intended sedation window and produce apnea, so syringe-driver-controlled infusion is preferred over hand injection. Filling of the sterile emulsion for laboratory use must meet the same USP <729> droplet limits as veterinary clinical products because pulmonary fat embolism is a terminal endpoint concern in small animals with high vascular surface-to-volume ratios. Any pharmacy that attempts to dissolve propofol in water for injection will produce a two-phase liquid that fails the sub-visible particle test of USP <788>; the API has a pKa near 11 and water solubility below 0.15 mg/mL. Aqueous lipid-free solutions containing modified cyclodextrins are investigational and are not interchangeable with the registered lipid emulsion; their toxicology profile in veterinary species is not established. This application is therefore limited to specialised research facilities with aseptic compounding capability and ready access to emergency airway equipment.
For zoological and exotic medicine, propofol is employed in short-duration procedures where inhalation anesthesia is technically impractical; however, the downstream formulation remains the lipid emulsion and not a tablet, granule or premix. Avian and reptile patients require vascular access for propofol because intramuscular injection is not a reliable induction route, and the lipid emulsion may cause injection-site reactions if extravasation occurs. The API concentration is normally prepared as a 10 mg/mL emulsion, and lower concentrations must not be produced by simple dilution with saline because electrolyte concentrations above the emulsion’s critical flocculation threshold cause droplet aggregation. Mixing with other injectable drugs is limited to those with documented compatibility in lipid emulsions; addition of acidic drug solutions can reduce the zeta potential of the egg lecithin interface and lead to creaming. In large exotic mammals, continuous-rate infusion protocols must be monitored for hyperlipaemia when the infusion exceeds 3 h or when plasma becomes visibly lipaemic; serum triglyceride elevations vary by species and fasted baseline readings should be established before infusion. Since the product is unpreserved, any multidose use in zoological settings must follow the same 6 h discard rule, and prepared syringes are labelled with the spiking time to prevent delayed administration of oxidised emulsion.
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Propofol veterinary-grade API is supplied as 2,6-diisopropylphenol, CAS 2078-54-8, molecular formula C12H18O, molar mass 178.27 g mol⁻¹. At controlled room temperature it is a clear, colorless to pale yellow liquid with a reported melting point near 18 °C, boiling point approximately 256 °C at atmospheric pressure, and log P near 3.8. The product is not a single commercial “model” in the sense of a finished dosage form; the article identifier is the lot-specific manufacturer grade code on the certificate of analysis, aligned to the current pharmacopeial monograph for propofol and the vendor specification sheet. It is an unformulated active pharmaceutical ingredient intended for licensed veterinary dosage manufacturing—sterile oil-in-water emulsion for intravenous injection, solutions, and, where technically justified, powders, granules, premixes, tablets, and capsules. The material is not sterile and is not a ready-to-administer injection; it must be compounded, sterilized, filled, and batch-released under an authorized quality system.
For an API that may enter sterile parenteral manufacture, the release panel must be broader than a simple assay. The following matrix lists test categories required or referenced for the neat substance; the supplier’s specification and the receiving site’s quality unit must assign actual values and limit ranges for each drug product dose.
| Attribute | Method or standard reference | Use in release and stability control |
|---|---|---|
| Assay | USP <621> HPLC, current propofol monograph | Mass balance after storage, thermal processing, and reprocessing |
| Related substances | USP <621> peak area normalization | Monitoring of oxidative quinone derivatives and alkylated phenols |
| Residual solvents | USP <467> | Synthetic solvent control from isopropylation and purification |
| Water content | USP <921> Karl Fischer | Hydrolytic stability and solid-dosage processing behavior |
| Bacterial endotoxins | USP <85> | Parenteral-dose endotoxin budget for sterile emulsion manufacture |
| Clarity and appearance | Current pharmacopeial monograph visual check | Color shift after light, oxygen, or trace metal exposure |
From a parenteral perspective, the bacterial endotoxin limit is not a single API number; it is derived from the maximum intended dose per kilogram and the route of administration under USP <85> or Ph. Eur. 2.6.14. The API should be low-bioburden, and any reprocessing or blending must not increase oxidative related substances. HPLC related-substances monitoring by USP <621> is necessary because propofol is susceptible to oxidative coupling and quinone formation in the presence of oxygen, light, or transition metal ions.
Where a tablet, capsule, powder, granule, or premix dosage form is under development, the liquid nature of propofol at ambient temperature governs the operation. Direct addition of neat liquid to a high-shear granulator without a carrier produces uneven distribution and binder-like agglomeration. A common processing route is adsorption onto a porous, low-moisture carrier such as silicified microcrystalline cellulose or colloidal silicon dioxide; the carrier ratio must be established by oil absorption capacity and not by simple weight percent. A free-flowing powder is characterized by USP <1174> flowability methods; a Carr index greater than 25 or a Hausner ratio above 1.25 indicates that granule flow is inadequate for high-speed tablet compression. In hard capsules, liquid-filled capsules may be preferable because the API remains a liquid under ordinary ambient conditions; powder-filled capsules require a homogeneous adsorbate. Content uniformity should be assessed by USP <905> and dissolution, if meaningful, by USP <711>. Oral propofol is subject to substantial first-pass metabolism, and published data for solid oral propofol in target veterinary species is limited; therefore, oral powders and premixes are typically not interchangeable with injectable anesthesia without a clear pharmacokinetic justification.
For sterile injectable emulsions, the API is dissolved in an oil phase containing refined soybean oil or an equivalent medium-chain/long-chain triglyceride, while an aqueous phase contains egg lecithin, glycerol, and water for injection. A primary coarse emulsion is formed in a rotor-stator high-shear mixer; the mixture is then passed through a two-stage high-pressure homogenizer. Production-scale units typically operate with a first-stage pressure between 500 bar and 1500 bar and a second-stage pressure near 50–150 bar. The outlet stream must be cooled to maintain bulk temperature below 30 °C during recirculation because shear heating and residence time can accelerate lipid oxidation. Nitrogen sparging of the aqueous and oil phases is used to reduce dissolved oxygen; a common control point is dissolved oxygen below 0.5 mg L⁻¹ before homogenization. Droplet size is evaluated by laser diffraction or dynamic light scattering using USP <429>; for injectable oil-in-water emulsions, a typical target is mean droplet diameter below 0.5 µm and D(v,0.9) below 1 µm. The final acceptance criterion must be derived from the authorized finished product specification, because batch size, homogenizer type, and lecithin lot can shift the distribution. Filtration is usually a pre-filtration or clarification step through a 0.45 µm membrane; terminal moist-heat sterilization is typically performed at 121 °C for 15 min using validated load patterns. Sterilizing-grade 0.22 µm filtration of a coarse emulsion is not generally used as the sole sterilization step because droplet size and viscosity can compromise filter capacity; the selected sterilization method must be supported by an appropriate sterility assurance level and microbial validation data.
Emulsion viscosity and pump shear remain process-limiting variables. At propofol concentrations near 10 mg mL⁻¹, the finished emulsion viscosity is close to that of water; however, high-pressure homogenizer recirculation can produce air entrainment if the tank return line is not submerged. Bulk density of the API, approximately 0.955 g cm⁻³, is close to that of soybean oil, so mixing during oil-phase preparation is not governed by severe density stratification; dissolving propofol in the oil phase before phase mixing avoids the high local pH that could deprotonate the phenol and alter partitioning. Homogenization pressure must be increased gradually; an immediate pressure spike can shear phospholipid layers and increase the coarse droplet fraction. In-process droplet size by USP <429> should be measured after the second pass and at the end of recirculation, because overprocessing can reduce droplet size but can also raise the peroxide value. A peroxide value check on the oil phase before and after homogenization provides a low-cost instability marker; values above the supplier limit indicate oxidative stress requiring lower dissolved oxygen or reduced residence time.
Because propofol is a phenolic liquid, storage of the API and its intermediate products requires oxygen and light exclusion. Bulk API is typically packaged in amber glass or fluoropolymer/HDPE containers under nitrogen and stored at controlled room temperature 15–25 °C. Solidification near 18 °C is a physical rather than chemical event; the container should be warmed to 20–25 °C in a temperature-controlled chamber before transfer. Localized heating above 40 °C should be avoided, and direct contact with copper or iron surfaces must be excluded because trace metal ions accelerate oxidative degradation. In aqueous emulsion systems, the chelator edetate disodium is used in some licensed formulations at 0.005% w/v to retard metal-catalyzed oxidation; compatibility with the target species and marketing authorization must be verified. The neat API should not be stored in contact with oxidizing agents, and repeated opening of bulk containers should be limited to avoid headspace oxygen ingress. Oxidative degradation is monitored by related-substances HPLC, with particular attention to quinone-derived impurities appearing after light or heat exposure.
For non-parenteral powders and premixes, residual oxygen in packaging is controlled by nitrogen flushing; oxygen scavengers may be used provided the scavenger material does not contact the product and is compatible with feed or drug-product regulations. Light exposure should be minimized during tabletting because the adsorbed state increases surface area and may accelerate photo-oxidation if a protective film or coating is absent. The maximum allowable hold time from API container opening to final package sealing must be established at the receiving site under the intended room humidity and lighting; published data for site-specific hold times is limited and cannot be transferred between equipment without a risk assessment.
On production-scale batches, the main failure mode is not propofol assay loss but emulsion destabilization and oxygen-related impurity growth. Homogenizer wear can release metal fines; the equipment should be passivated 316L-grade stainless steel, and filter integrity tests should be included after each campaign. Egg lecithin and soybean oil lots vary in phospholipid profile and free fatty acid content; these shifts can alter droplet surface charge and viscosity even when the propofol API lot remains within assay specification. Tighten raw-material acceptance for phospholipid content and acid value through supplier COA review. The API itself should be protected from repeated solidification–remelting cycles because solidification and remelting may create localized concentration gradients if the container is not mixed after liquefaction. Cleaning from stainless steel tanks and transfer lines requires an alcohol-based solvent such as isopropyl alcohol followed by aqueous detergent; water alone is insufficient because propofol has low aqueous solubility, generally below 1 mg mL⁻¹ at room temperature. Rinse verification should be by HPLC or a validated cleaning limit consistent with the next product’s permitted daily exposure.
For premixes intended for oral administration or feed incorporation in food-producing species, the API must be stable in the feed matrix and the withdrawal period must be established by residue studies; propofol is not generally approved for feed-based anesthesia because its oral pharmacokinetics and first-pass clearance are incompatible with reliable induction. Use of propofol premix in medicated feed should be explicitly justified by the target species label or investigational protocol and is not appropriate by default. The difference from a soluble powder or effervescent granule product is that ordinary dry granulation and compression cannot be performed until the liquid API is adsorbed and the carrier system is qualified for content uniformity and stability.
Veterinary-grade propofol shares the same chemical identity as human-grade propofol, but the two are not automatically interchangeable in a regulatory submission. Human-use API may require a Certificate of Suitability, a US Drug Master File, or equivalent national authorization following ICH Q7 and EU GMP Part II. Veterinary use may follow the same GMP framework, but the application pathway, target-species residue and withdrawal requirements, and labeling sit under veterinary medicinal product regulations. The receiving site must map the vendor’s quality system to the intended filing; a veterinary API lot cannot be assigned a human pharmacopeial release by relabeling alone.
Compared with other anesthetic APIs, propofol differs in both physical form and formulation route. Thiopental sodium is a lyophilized barbiturate salt requiring reconstitution, whereas propofol is a liquid phenolic drug that must be emulsified for stable intravenous administration. Alfaxalone is a neuroactive steroid formulated in some veterinary injectables with a cyclodextrin-based solubilizing system, while propofol requires a phospholipid-stabilized oil-in-water emulsion. Clinically, propofol is a short-acting central nervous system depressant acting at GABAA receptors; it provides no analgesic effect, and its toxicological signature includes dose-dependent respiratory depression and hypotension. The API cannot guarantee these clinical behaviors unless the finished dosage form is manufactured with controlled droplet size, low oxygen, and appropriate sterility assurance. In companion-animal and food-producing species, the route, dose, tissue withdrawal, and species-specific toxicity must be established by the applicant; the API specification alone is not a clinical safety statement.
