| HS Code | 830879 |
| Product Name | Methoxyflurane Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Chemical Name | 2,2-dichloro-1,1-difluoroethyl methyl ether |
| Cas Number | 76-38-0 |
| Molecular Formula | C3H4Cl2F2O |
| Molecular Weight | 164.97 g/mol |
| Structural Formula | CHCl2-CF2-O-CH3 |
| Grade | Veterinary Grade |
| Physical State | Liquid |
| Color | Colorless |
| Odor | Characteristic ethereal odor |
| Solubility | Slightly soluble in water; miscible with ethanol, ether, chloroform, and oils |
| Melting Point | -35 °C |
| Boiling Point | 104.7 °C |
| Density | 1.426 g/cm3 at 20 °C |
| Vapor Pressure | 22.5 mmHg at 20 °C |
| Refractive Index | 1.385 at 20 °C |
| Purity | ≥99.0% (Veterinary Grade) |
| Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Storage | Keep container tightly closed in a cool, dry, well-ventilated area protected from light |
As an accredited Methoxyflurane 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 | Methoxyflurane Veterinary Grade API supplied in 250 mL amber glass bottles, sealed under nitrogen with tamper-evident closures for stability. |
| Container Loading (20′ FCL) | A 20′ FCL shipment of Methoxyflurane veterinary-grade API, safely loaded in tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Shipment requires compliance with hazardous materials regulations. Methoxyflurane must be packaged in airtight, UN-approved containers, protected from heat, light, and ignition sources. Include proper hazard labeling, documentation, and temperature-controlled transport. Ensure secure segregation from incompatible substances to maintain stability and safety across all dosage forms. |
| Storage | Store Methoxyflurane Veterinary Grade API in a tightly sealed, original container, protected from light and moisture. Keep in a cool, dry, well-ventilated area away from heat, sparks, and open flames. Store between 15–25°C unless otherwise specified. Avoid contact with air and oxidizing agents. Keep out of reach of children and unauthorized personnel. |
| Shelf Life | Shelf life is the duration Methoxyflurane veterinary API remains stable and effective under defined storage conditions for each dosage form. |
Methoxyflurane veterinary grade API is supplied as a clear, colourless, volatile halogenated ether liquid with a published boiling point of approximately 104 °C and vapour pressure below 5 kPa at 20 °C. The liquid state and vapour-phase administration route exclude direct incorporation into tablets, capsules, powders, granules, premix, and aqueous injectable solutions without introducing stability and dose-uniformity deviations that are not resolved in veterinary pharmacopoeial monographs for this substance. Downstream processing therefore centres on inhaler reservoir filling, vapour-specific bottle repackaging, draw-over vapour delivery, and non-aqueous liquid handling under nitrogen. The scenarios below reflect the actual landed veterinary sectors in which methoxyflurane is used as an inhaled analgesic or anaesthetic; solid-dose and injectable claims are not included because published data for those configurations is limited or absent.
In veterinary emergency and trauma triage, the API is filled into single-use handheld inhaler devices for canine and feline procedural analgesia. Compliance for the finished device is assessed under ISO 8835-4:2004 for vapour delivery devices, with API residual solvent control aligned to VICH GL18 and manufacturing records maintained under FDA 21 CFR Part 211 current good manufacturing practice. Formulation addition is not expressed as a solid disintegrant or diluent ratio; the methoxyflurane liquid is charged at 3 mL per inhaler wick, and the reported delivered inspired concentration for analgesia is maintained in the range 0.2% v/v to 0.8% v/v depending on patient ventilation and ambient temperature. Downstream production involves nitrogen-blanketed filling of the volatile liquid onto a high-surface-area polypropylene wick, insertion into a cylindrical aluminium body, crimping of an activated charcoal-loaded exhalation chamber, and leak testing under negative pressure. The terminal finished product is a single-use inhaler kit with a mouthpiece and an activated charcoal adsorption chamber, packaged in a sealed foil laminate to limit evaporative loss. Prolonged maintenance with this agent is constrained by the known fluoride-ion nephrotoxicity profile, so procedural use is typically limited to short-duration analgesia rather than long surgical maintenance.
For adult equine patients, methoxyflurane is used in standing chemical restraint and field sedation, where anaesthetic depth must remain below recumbency thresholds. The primary equipment standard is ISO 80601-2-13:2011 for anaesthetic workstations, while the vapour delivery device is validated to ISO 8835-4:2004; residual solvent monitoring is conducted under VICH GL18. The formulation addition ratio is set by vapour output rather than bulk dilution: reported standing sedation protocols use delivered concentrations between 0.05% v/v and 0.3% v/v in oxygen at fresh gas flow rates from 1 L/min to 3 L/min. At concentrations above 0.3% v/v, ataxia and loss of standing posture are observed, so delivered concentration must be read continuously from a calibrated temperature-compensated plenum vaporizer. Downstream production for this sector includes filling of high-purity methoxyflurane into 250 mL or 500 mL amber glass vapour-specific bottles fitted with keyed filler systems to prevent cross-fill error, followed by batch assay of non-volatile residue and moisture below monograph thresholds. The terminal product is a vapour-specific reservoir bottle used exclusively with methoxyflurane-calibrated veterinary vaporizers; no solid or injectable form is produced for this indication.
For rodent minor-surgical protocols in contract research vivaria, methoxyflurane is delivered through calibrated active-scavenging systems to maintain a surgical plane while limiting cumulative organ exposure. Compliance is tied to ISO 8835-4:2004 for delivery device performance and to institutional animal care standards that require waste gas scavenging; API identity and purity are controlled under the current USP-NF methoxyflurane monograph and residual solvent guidance in VICH GL18. The formulation addition ratio is controlled strictly by vapour concentration: induction chambers are charged with 1.0% v/v to 1.5% v/v methoxyflurane in oxygen, whereas maintenance during minor procedures is reduced to 0.2% v/v to 0.6% v/v in non-rebreathing circuits. Downstream processing in the laboratory setting requires low-permeation polytetrafluoroethylene-lined tubing and minimum dead-space connectors to reduce vapour absorption into polymeric components, with active exhaust at 15 to 20 air changes per hour passing through activated charcoal canisters before release. The terminal product is an anaesthetic induction chamber/vaporizer kit supplied as a non-sterile gas delivery system, not a finished drug dosage form. Published data for rodent-specific methoxyflurane pharmacokinetics under modern IACUC protocols is limited, so dose refinement is confirmed by righting-reflex loss and pedal withdrawal rather than fixed posology.
Table 1 summarises reported vapour-concentration windows across representative veterinary use sectors. Site-specific vaporizer calibration and species-specific minimum alveolar concentration determinations override these ranges.
| Species / Procedure class | Reported delivered concentration | Primary compliance reference |
| Canine / feline procedural analgesia | 0.2% v/v to 0.8% v/v | ISO 8835-4:2004 |
| Equine standing sedation | 0.05% v/v to 0.3% v/v | ISO 80601-2-13:2011 |
| Rodent minor surgery | 0.2% v/v to 0.6% v/v | ISO 8835-4:2004 |
| Wildlife field immobilisation | 0.1% v/v to 0.5% v/v | VICH GL18 |
| Avian / exotic maintenance | 0.2% v/v to 0.7% v/v | ISO 80601-2-13:2011 |
Compounding pharmacies repackaging methoxyflurane API for veterinary hospital use must address the liquid’s high vapour pressure and solubility in common elastomers. The governing standards for non-sterile compounding include USP 795 and, where applicable, regional veterinary compounding rules; container-closure compatibility is assessed against the API’s monographed purity limits. Formulation addition is performed as undiluted liquid fill at 100% API; no excipient dilution is used because the vapour delivery calibration depends on the unmodified saturated vapour pressure of the pure substance. Headspace is minimised to less than 5% of container volume, and fill volume is commonly 5 mL or 10 mL in glass ampoules or perfluoroalkoxy-lined bottles. Downstream processing includes filtration through a 0.22 µm polytetrafluoroethylene membrane under nitrogen pressure, transfer into pre-dried borosilicate glass or perfluoroalkoxy containers, and closure with polytetrafluoroethylene-faced butyl septa to reduce evaporative loss and plasticizer leaching from slower-aging elastomers. The terminal product type is a vapour-specific liquid reservoir or ampoule for vaporizer refill, not a standard tablet or capsule. Any requested solid-dose compounding is rejected on physical stability and dose-uniformity grounds because methoxyflurane does not form a stable solid matrix under ordinary pharmaceutical processing conditions.
Remote wildlife immobilisation programmes use draw-over vapour delivery because compressed medical oxygen is often unavailable in the field. The compliance framework for the API in this setting is VICH GL18 for residual solvents and ISO 8835-4:2004 for vapour delivery device output; field hardware is routinely tested against the manufacturer’s calibration certificate rather than a full anaesthetic workstation standard. The addition ratio is expressed as liquid charge in self-fill or pre-filled portable draw-over devices: 3 mL or 5 mL of undiluted API is loaded into a temperature-stabilised wick chamber, producing inspired concentrations in the 0.1% v/v to 0.5% v/v range for small- to medium-sized mammals when ambient air is used as the carrier gas. Downstream production for this sector emphasises low-temperature operability, because methoxyflurane vapour delivery in draw-over systems is temperature-dependent; cold-start performance at 5 °C is reported to be lower than at 20 °C, requiring pre-warmed wick housings before use. The terminal product is a field draw-over inhaler kit with a low-resistance one-way valve and an activated charcoal passive scavenging canister. Published data for specific wildlife species is limited, and delivered concentration must be titrated against withdrawal reflexes and respiratory rate rather than fixed species-specific tables.
Avian and exotic animal anaesthesia demands low dead-space circuits and tight vapour concentration control because of small tidal volumes and high minute ventilation relative to body mass. The principal standard for delivery equipment is ISO 80601-2-13:2011, supplemented by ISO 8835-4:2004 for the vaporizer; API residual solvent and purity control follow VICH GL18 and the USP-NF methoxyflurane monograph. The formulation addition ratio is controlled at the vaporizer: reported maintenance settings for birds are between 0.2% v/v and 0.7% v/v, with fresh gas flows as low as 500 mL/min in Ayres T-piece or modified Jackson non-rebreathing systems; higher concentrations produce rapid respiratory depression in small patients. Downstream production of the gas delivery components involves use of low-compliance, low-permeation tubing with internal diameter below 4 mm to minimise mechanical dead space, and fitting with a specifically sized avian facemask or chamber. The terminal product is a paediatric/exotic mask-and-circuit gas delivery system paired with a precision vaporizer and active scavenging. Because methoxyflurane is absorbed into standard PVC and latex components, only fluoropolymer or polyethylene-lined circuit materials are used; otherwise delayed release from tubing causes unintended post-procedure re-sedation and unpredictable emergence times.
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Methoxyflurane Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied as a clear, colourless, mobile liquid under the bulk material designation MFL-VET-API. The active substance is 2,2-dichloro-1,1-difluoroethyl methyl ether, CAS 76-38-0, with molecular formula C3H4Cl2F2O and relative molecular mass 164.97 g/mol. The material is manufactured for downstream veterinary pharmaceutical manufacturing and compounding operations requiring a pharmacopoeial-grade volatile anaesthetic API. Standard pack configurations include fluorinated high-density polyethylene drums of 10 L, 25 L, and 210 L; the 25 L container is designated MFL-VET-API-025L, and the 210 L container is designated MFL-VET-API-210L. Each drum is sealed under nitrogen headspace and fitted with a fluoropolymer gasketed closure.
The liquid exhibits a boiling point of 104.6 °C at 101.325 kPa, a vapour pressure of 22.5 mm Hg at 20 °C, and a density of approximately 1.42 g/mL at 25 °C. It is sparingly soluble in water and freely miscible with ethanol, acetone, and chlorinated solvents. The saturated vapour concentration at 20 °C is approximately 3% by volume; this places an upper limit on output for passive wick-type vaporisers unless supplemental heat is applied to the wick chamber. The anhydrous material is stabilised against oxidative degradation with butylated hydroxytoluene at a typical release concentration of 0.01% w/w. Oxidative degradation is accelerated by light, copper, and strong alkali; these incompatibilities must be controlled in transfer lines, container closures, and compounding equipment.
Release and shelf-life testing is performed by gas chromatography with flame ionisation detection and compendial general methods. The following parameters are normally reported on a certificate of analysis; the registered specification for a finished veterinary medicinal product may include additional tests for degradation products or delivery characteristics.
| Parameter | Method / Standard | Release Limit |
|---|---|---|
| Assay of methoxyflurane | GC-FID, USP monograph | 98.0–102.0% w/w |
| Related substances | USP <621> chromatography | total impurities ≤2.0%; unspecified individual ≤0.10% |
| Water | Karl Fischer, USP <921> | ≤0.1% w/w |
| Residual solvents | USP <467>, ICH Q3C | Class 1 solvents not detected; Class 2 solvents within option 1 limits |
| Stabiliser content | HPLC-UV | 0.008–0.012% w/w butylated hydroxytoluene, when stated |
| Identification | IR absorption, USP <197> | concordant with reference spectrum |
Stability in unopened original containers is typically supported by real-time data at 25 °C/60% RH and accelerated data at 40 °C/75% RH; retest periods should not exceed the compendial or supplier-supported shelf life. Storage should be maintained between 15 °C and 30 °C, protected from light. Containers should be re-sealed under inert gas after sampling. Repeated partial withdrawal from a single drum can increase water uptake and volatile loss; a pressure-balancing inerting manifold is recommended for production-scale use.
In non-aqueous solutions intended for vaporiser filling or veterinary compounding, methoxyflurane is filtered through a 0.45 µm hydrophobic membrane and filled into amber Type I glass bottles or fluoropolymer-lined aluminium canisters. Fill-volume tolerances for sealed glass bottles must allow for vapour-phase expansion. Leak testing is conducted under partial vacuum according to the container-closure validation protocol. Because the active substance is prone to evaporative loss, gravimetric verification of fill weight is performed at the start, middle, and end of each filling campaign; accepted variance is usually set at ±2% of target fill weight unless the marketing authorisation specifies a tighter limit.
Powder and granule intermediates are prepared by spraying the liquid API onto microcrystalline cellulose, colloidal silicon dioxide, or mesoporous silica under a nitrogen stream at a product temperature of ≤20 °C. High-shear wet granulation with aqueous binders is generally unsuitable because the active substance may volatilise during tray drying or fluid-bed drying above 30 °C. Granules produced by non-aqueous solvent granulation should be dried under reduced pressure at ≤25 °C to a loss on drying of ≤2.0% w/w. Homogeneity of the adsorbed API should be verified by sampling the top, middle, and bottom of the blender; an in-process alert limit of ±5% of theoretical concentration is commonly applied.
Tablet compression of methoxyflurane-containing granules requires a low-speed rotary tablet press fitted with an enclosed feed frame and dust extraction. Relative humidity in the compression suite should be kept below 30% RH to prevent moisture-induced hydrolysis and sticking. Hardness, friability, and disintegration should be tested using USP <1217>, USP <1216>, and USP <701> as applicable. Capsule filling is performed on a dosator or tamping-pin machine with a cooled powder hopper to reduce volatilisation; moisture-sensitive capsule shells should be pre-dried and filled immediately after loading. Published data for solid oral dosage forms containing methoxyflurane is limited; feasibility batches are required before scale-up.
Injectable dosage forms are not established in major veterinary pharmacopoeial monographs. An anhydrous oil-based or non-aqueous solvent system would be required; aqueous parenterals are impractical because methoxyflurane is sparingly soluble in water and undergoes hydrolysis in contact with free water at elevated pH. Steam sterilisation is incompatible with the low boiling point, so sterilising filtration through a 0.22 µm hydrophobic membrane is the only practical terminal treatment for a non-aqueous liquid formulation, provided membrane integrity is verified by bubble point. Sterility assurance must follow Ph. Eur. 5.1.1, endotoxin testing Ph. Eur. 2.6.14, and leachable evaluation according to the container-closure system. Because no compendial injection monograph exists, any injectable use must be supported by a veterinary prescription or a registered product in the relevant jurisdiction.
Compared with isoflurane and sevoflurane, methoxyflurane has a markedly higher blood:gas partition coefficient of approximately 12, which delays equilibration between alveolar gas and central nervous tissue and produces slow induction and prolonged recovery unless anaesthetic depth is actively managed. Its minimum alveolar concentration in dogs is approximately 0.2% by volume, lower than isoflurane at 1.3%, sevoflurane at 2.4%, and halothane at 0.9%. The low saturated vapour pressure of methoxyflurane limits the maximum inhaled concentration at room temperature to roughly 3%; this is nevertheless sufficient for anaesthesia because of the low minimum alveolar concentration. Methoxyflurane also provides more pronounced somatic analgesia and muscle relaxation at subanaesthetic concentrations than modern volatile agents, but it undergoes extensive hepatic metabolism, with published estimates of 50–75% of the absorbed dose being metabolised to inorganic fluoride. This creates a dose-dependent risk of renal tubular injury that is not present to the same extent with isoflurane or sevoflurane.
| Property | Methoxyflurane | Isoflurane | Sevoflurane | Halothane |
|---|---|---|---|---|
| Boiling point at 101.325 kPa | 104.6 °C | 48.5 °C | 58.5 °C | 50.2 °C |
| Vapour pressure at 20 °C | 22.5 mm Hg | 238 mm Hg | 160 mm Hg | 243 mm Hg |
| Minimum alveolar concentration in dogs | 0.2% | 1.3% | 2.4% | 0.9% |
| Blood:gas partition coefficient | 12 | 1.4 | 0.69 | 2.3 |
| Approximate hepatic metabolism | 50–75% | <0.2% | 5% | 15–20% |
In production-scale vaporiser filling and bulk transfer, the lower vapour pressure of methoxyflurane reduces evaporative loss relative to isoflurane, but its higher lipid solubility increases the cleaning burden on stainless steel, silicone elastomer, and perfluoroelastomer transfer lines. Cleaning validation should include swab and rinse sampling for active substance and stabiliser; a typical swab limit is set at 10 ppm of methoxyflurane in the next batch, calculated from permitted daily exposure and equipment surface area. The product should not be combined with amine-based additives or strongly alkaline excipients because dehalogenation can generate fluoride ions and acidic degradation products that accelerate container corrosion.
During compounding of premixes for feed or oral administration, the API is added to a non-aqueous carrier or adsorbed onto a dry diluent. Mixing is performed in stainless steel ribbon blenders or ploughshare mixers under closed vacuum-rated covers to minimise worker exposure. Homogeneity testing of the premix should follow the sampling scheme in the registered veterinary product specification or Ph. Eur. 2.9.40 where a single-dose unit claim is made; an acceptance criterion of 90.0–110.0% of declared potency with a relative standard deviation of not more than 5.0% is commonly applied. Because methoxyflurane can migrate from the premix carrier during storage, retain samples should be placed in sealed aluminium foil pouches with desiccant and stored at 25 °C for the intended period of use.
Occupational exposure during manufacture should be controlled by closed transfer, local exhaust ventilation, and continuous photoionisation detection in the compounding suite. Methoxyflurane exposure limits should be confirmed in the relevant jurisdiction because published occupational exposure thresholds vary. Handling of opened containers is limited to qualified personnel wearing chemical-resistant gloves and tight-fitting safety goggles. Spill control uses inert absorbent such as vermiculite, with disposal under hazardous waste provisions for halogenated solvents.
Manufacture, release, and distribution follow ICH Q7, 21 CFR 210/211, and EudraLex Volume 4 Part II as applicable to active substances and finished veterinary medicinal products. Certificates of analysis should include residual solvent data according to ICH Q3C and USP <467>, elemental impurities according to USP <232> and ICH Q3D, and a nitrosamine risk evaluation in line with current veterinary regulatory guidance. The product should not be released without identification by infrared absorption, chromatographic retention time, and physical appearance against the current pharmacopoeial monograph.
Batch-to-batch variability is controlled by stabiliser content, water value, and related substances profile. Production-scale failure modes encountered with methoxyflurane include container leakage, moisture ingress during repeated sampling, and underfill due to vapour displacement in automated filling lines. These failure modes are addressed through gravimetric fill verification, container-integrity testing by vacuum decay, and moisture audit testing at first opening. The operational boundary for routine handling is therefore defined by closed-nitrogen transfer, moisture exclusion, and avoidance of elevated temperatures above 30 °C in open systems.
