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Fenthion Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    • Product Name: Fenthion Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
    • Factroy Site: Yudu County, Ganzhou, Jiangxi, China
    • Price Inquiry: admin@ascent-chem.com
    • Manufacturer: Ascent Petrochem Holdings Co., Limited
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    Specifications
    HS Code 661486
    Product Name Fenthion Veterinary Grade API
    Chemical Name O,O-Dimethyl O-(3-methyl-4-methylthiophenyl) phosphorothioate
    Cas Number 55-38-9
    Molecular Formula C10H15O3PS2
    Molecular Weight 278.33 g/mol
    Appearance Colorless to light yellow oily liquid
    Purity ≥ 98.0%
    Solubility Soluble in most organic solvents; practically insoluble in water
    Compatibility With Dosage Forms Tablets, injections, capsules, powders, granules, premix, and solutions
    Storage Conditions Store in tightly closed containers in a cool, dry place protected from light
    Shelf Life 24 months when stored under recommended conditions
    Pharmacological Classification Organophosphorus ectoparasiticide
    Mechanism Of Action Acetylcholinesterase inhibitor
    Veterinary Indications Control of fleas, ticks, lice, and other external parasites in animals

    As an accredited Fenthion 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 & Storage
    Packing Fenthion Veterinary Grade API available in 25 kg sealed drums, suitable for tablets, injections, capsules, powders, granules, premix, and solutions.
    Container Loading (20′ FCL) 20′ FCL loading of Fenthion veterinary grade API, safely packed in sealed containers for tablets, injections, capsules, powders, granules, premix, and solutions.
    Shipping Fenthion Veterinary Grade API is shipped in UN-certified, sealed containers to prevent leakage and contamination. Shipments require hazardous material labeling, Safety Data Sheets, and compliance with international transport regulations. Avoid moisture, heat, and direct sunlight. Use dedicated cargo space with proper ventilation for safe handling.
    Storage Store Fenthion Veterinary Grade API in a tightly sealed, original container in a cool, dry, well-ventilated area. Protect from direct sunlight, excessive heat, moisture, and ignition sources. Avoid freezing for solutions/injections. Keep away from incompatible materials, food, and animal feed. Use appropriate PPE when handling. Ensure container is adequately labelled and secured.
    Shelf Life Shelf life: 24 months from manufacture date when stored in original, tightly closed container below 30°C, protected from light and moisture.
    Application of Fenthion Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    Fenthion Veterinary Grade API is supplied for downstream veterinary formulation work; however, the tablet, injectable, and capsule presentations listed in the raw-material scope do not correspond to established fenthion administration routes in the published regulatory record. The application scenarios below therefore cover only load-bearing formulation routes for which industrial processing parameters, quality-control standards, and terminal product formats are available. Each scenario treats a separate downstream manufacturing environment and avoids duplicative general statements.

    Anhydrous solvent architecture for companion-animal spot-on fenthion formulations

    Fenthion Veterinary Grade API is a low-melting organothiophosphate with limited water solubility; therefore non-aqueous cutaneous solutions are prepared by dissolving the liquid active directly into an anhydrous solvent system composed of a medium-chain glycol ether and a high-boiling pyrrolidone or ester co-solvent. The finished product is a single-dose or small-volume multidose solution applied to the dorsal midline of dogs and cats for control of flea and tick infestations. Regulatory dossiers for this presentation fall under EU Regulation 2019/6 and, where the product is registered as a pesticide/ectoparasiticide in certain jurisdictions, FAO/WHO pesticide specification procedures. Analytical release testing typically references VICH GL1 for method validation and VICH GL18 for residual solvent limits; residual ethylene oxide from any sterilized primary packaging is assessed against Ph. Eur. 5.1.4. The active loading in commercially encountered spot-on systems is generally expressed as a percentage weight per volume; published compendial monographs do not establish a single harmonized strength, and a specific addition ratio must be fixed by the marketing-authorization holder using dermal absorption and target animal safety data. Where formulation studies are performed, fenthion concentrations of 5.0%–10.0% w/v are encountered in solvent-based pipette products; this range is not a regulatory monograph value and must not be used as an off-label compounding instruction. Downstream processing uses stainless-steel mixing vessels with bottom-mounted propeller agitation under nitrogen blanketing, followed by 0.45 µm membrane filtration and automated filling into polypropylene pipette shells. Water content is maintained below 0.1% w/w because trace moisture accelerates hydrolytic degradation of the fenthion molecule and can produce cloud-point shifts in the solvent matrix. The terminal product type is a single-dose monodose pipette or a 50 mL–100 mL multidose bottle with a metering dropper.

    When dermal absorption becomes the rate-limiting step in cattle pour-on products

    Pour-on formulations are prepared as medium-viscosity liquid systems designed to spread along the backline of cattle after application from a dosing gun. The critical process target is not merely solution clarity but the creation of a residence time on the hair and skin that permits transdermal flux sufficient to control Hypoderma spp. larvae and lice. Dossiers submitted under EU Regulation 2019/6 require residue depletion studies under VICH GL46; toxicological assessment of residues in food-producing species is assessed in accordance with Commission Regulation (EU) 2018/470 and related MRL classifications. Fenthion concentrations in registered pour-on formulations are species-specific and are fixed by the withdrawal period; no uniform formula exists. Published label and formulary data for fenthion pour-on products is limited; when formulation-batch development is authorized, active loadings in the range of 3.0% w/v–10.0% w/v have been described in external technical bulletins, but these values are not a compendial specification. Downstream production involves weighing the liquid API into a jacketed stainless-steel reactor, adding a low-volatility ester/alcohol solvent system, and maintaining a jacket temperature of 25°C–35°C while mixing at 100–150 rpm. The solution may be thickened with a polymeric acrylic rheology modifier to achieve a viscosity of 50–200 mPa·s measured by Brookfield viscometer at 25°C with spindle LV-2 at 12 rpm. Filled into HDPE or fluorinated HDPE dosing containers; terminal product is a 500 mL–5 L pour-on canister with calibrated applicator.

    In plunge dip and high-volume spray operations, fenthion is not handled as a finished low-concentration solution; it enters the formulation chain as an emulsifiable concentrate that is diluted with water at the farm or in a contract application unit. Emulsifiable concentrates are prepared by dissolving fenthion in an aromatic or paraffinic solvent blend together with an anionic/nonionic emulsifier package selected to produce spontaneous emulsification and stable oil-in-water emulsion upon dilution into hard water. The industry compliance framework for this presentation is split between veterinary medicinal product regulations and pesticide specification systems: EU Regulation 2019/6 applies when the product is authorized as a veterinary medicine; in countries where dip/spray products are registered as agricultural or public-health pesticides, WHO/FAO Joint Meeting on Pesticide Specifications guidance and CIPAC MT36.3 emulsion stability protocols are used. Fenthion addition in the concentrate is not standardized across all registrations; published label data for fenthion veterinary dip concentrates is limited. For formulation screening, active contents from 250 g/L to 500 g/L have been cited in supplier technical documentation, but the working dip must be diluted per national label and is typically in the range of 0.025%–0.05% w/v active ingredient. Production of the concentrate uses a high-shear disperser operating at 3,000–5,000 rpm for emulsifier predissolution, followed by low-energy static blending in a closed reactor to avoid volatile solvent loss. The pH of the finished concentrate is adjusted with a small quantity of buffering acid to pH 4.0–5.5 before filling into lacquer-lined steel or HDPE drums. Alkaline neutralizing agents and amine-based detergent residues must be excluded from process lines because pH elevation above 7.0 accelerates hydrolytic cleavage. Terminal products are 1 L–200 L dip concentrates and 5 L–20 L farm-pack spray concentrates.

    What limits wettable-powder flowability in back-rubber and dust-bag stations?

    Wettable powders and dust products for self-treatment stations require a dry carrier that accepts liquid fenthion without forming pastes or agglomerates. Because the active ingredient is a viscous liquid at ambient temperature, adsorption onto precipitated silica, attapulgite clay, or calcium silicate is performed before blending with anticaking agents and dispersants. The final dust or wettable powder must maintain free-flow properties at ambient humidity and resist cake formation in 25 kg valve bags during warehouse storage. Bulk storage of the carrier is pre-dried when ambient RH exceeds 60% to prevent caking in valve bags. Compliance for these solid presentation formats follows EU Regulation 2019/6 when the product is a veterinary medicine, and WHO/FAO dustable powder or wettable powder specifications where registered as a pesticide. CIPAC MT168 for dry flowability and CIPAC MT59 for suspensibility are used to assess batch consistency. Fenthion concentration in finished dusts is species- and site-specific; published label data for fenthion dust-bag products remains limited. Typical active loadings in dust formulations encountered in international trade are 1.0%–3.0% w/w, while wettable-powder concentrates may carry higher loadings of 25.0% w/w–40.0% w/w for dilution before spraying. Downstream blending utilizes a ribbon mixer or a low-shear ploughshare mixer with a sprayed-on liquid admixture system; the fenthion is warmed to 35°C–40°C to lower viscosity and sprayed through twin-fluid nozzles onto the carrier at 2–4 bar atomizing pressure. Final particle-size control by air-jet milling or sieve classification maintains a median particle size D50 of 5 µm–15 µm for wettable powders and D50 of 20 µm–50 µm for dust-bag products. Terminal product types include 10 kg–25 kg water-soluble sachets, shaker cans, and dust-bag refill cartridges.

    Formulation routeGoverning standard / regulationTest method designationMeasured parameter
    Non-aqueous spot-on solutionEU Regulation 2019/6; VICH GL18; Ph. Eur. 5.1.4Karl Fischer titrationwater content; dynamic viscosity
    Pour-on solutionEU Regulation 2019/6; VICH GL46Residue depletion studydermal absorption; withdrawal period
    Emulsifiable concentrateWHO/FAO JMPS; CIPAC MT36.3Emulsion stability testcream separation after 2 h
    Wettable powder / dust premixCIPAC MT59; CIPAC MT168suspensibility; dry flowsuspensibility; flow time
    Polymer matrix collar / ear tagASTM D638-14; ISO 1133-1:2022tensile test; melt flow testtensile strength; melt volume-flow rate
    Granular larvicideCIPAC MT170; CIPAC MT168dry sieve; flowparticle size; flow time

    Because a liquid active ingredient migrates through plasticised vinyl at a rate governed by solubility coefficient and matrix free volume, fenthion-loaded collars and ear tags demand compounding temperatures below the onset of organophosphate decomposition. In polyvinyl chloride resin, dry blending of fenthion with dioctyl phthalate or diisooctyl phthalate plasticizer, epoxidized soybean oil co-stabilizer, and calcium-zinc stearate is followed by twin-screw extrusion with segmented barrel zones having an L/D ratio of 40:1 and melt temperatures between 155°C and 175°C. A melt cooler and strand pelletizer produce compound pellets with active loading commonly 5.0%–10.0% w/w; the exact ratio is dictated by target release rate, collar surface area, and species-specific safety assessment under VICH GL21. Compliance dossiers cite EU Regulation 2019/6, FDA 21 CFR 211, and ASTM D638-14 Type IV tensile testing for mechanical integrity of the extruded strip. Production-scale equipment behavior shows that barrel zone temperatures above 180°C cause discoloration and a rapid drop in ester content; processing lines therefore include gravimetric feeders with loss-in-weight control to avoid formulation drift exceeding ±2% of target active loading. The extrudate is slit into strips, punched with buckle holes, and thermally edge-sealed. Terminal product types are continuous polymer strips with reflective outer layers and cattle ear tags with a minimum service life of 8–16 weeks.

    Granular fly-control matrices in manure-rich housing and feedlot runoff areas

    Granular fenthion products are designed for broadcast application to manure packs, drainage areas, and other substrates where filth flies complete larval development. The formulation must resist premature release during storage but disintegrate into moisture films after application. Fenthion is impregnated onto pre-formed carriers such as corn cob granules, expanded clay, or montmorillonite clay at addition rates determined by national pesticide registration. Published data for this specific configuration is limited; where fenthion granular formulations are available, active concentrations of 1.0% w/w–2.0% w/w are common in the finished granule, while manufacturing premix granules may be produced at higher loadings for controlled dilution. Compliance for this non-animal-contact use falls under pesticide registration frameworks rather than veterinary medicine; analytical verification uses CIPAC MT170 for dry sieve analysis and CIPAC MT168 for flowability. Downstream manufacturing uses a rotary drum impregnator or fluid-bed granulator; fenthion liquid is metered at 0.5 L/min–2.0 L/min onto the carrier bed under continuous temperature monitoring. The granules are dried at 40°C–50°C to final moisture below 1.0% w/w, sieved to a target particle size of 0.5 mm–2.0 mm, and packed in 25 kg woven polyethylene bags. Terminal product types are agricultural-use granules and livestock premise granules.

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    Certification & Compliance
    More Introduction

    Fenthion Veterinary Grade API is the O,O-dimethyl O-(3-methyl-4-methylthiophenyl) phosphorothioate intermediate used in the manufacture of approved ectoparasiticidal dosage forms. The compound is identified by CAS 55-38-9 and has the molecular formula C₁₀H₁₅O₃PS₂ with a relative molecular mass of 278.33 g mol⁻¹. Technical-grade material is a pale yellow to brown oily liquid with water solubility of approximately 2 mg L⁻¹ at 20 °C and an octanol-water partition coefficient log P of approximately 4.84. These properties define downstream formulation constraints for tablets, injections, capsules, powders, granules, premix, and solutions: the API is lipophilic, poorly water-soluble, and susceptible to alkaline hydrolysis. Published compendial monographs specific to fenthion veterinary API are limited; industrial certificates of analysis commonly apply a validated reversed-phase HPLC assay, loss on drying by USP <731>, and Karl Fischer water determination by USP <921> Method Ia.

    What Limits Direct Aqueous Conversion of Fenthion Veterinary API?

    Direct aqueous conversion without co-solvent is constrained by the solubility value and hydrolysis behavior. The molecule remains comparatively stable in mildly acidic media but hydrolyzes at pH above 7.0, with degradation controlled by pH, temperature, and buffer concentration. Production-scale preparation of liquid veterinary formulations therefore uses propylene glycol, glyceryl triacetate, or approved nonionic surfactant systems to maintain homogeneity. Water-based injection solutions are not generally feasible without a mixed solvent system because phase separation occurs at the target concentration. In a 500 L stainless-steel jacketed vessel fitted with turbine agitation at 40–60 rpm, the API is usually pre-dissolved in the solvent fraction before addition to the aqueous phase to avoid high-shear droplet rupture and phase inversion. Amine-buffered vehicles are contraindicated because nucleophilic amine buffers accelerate phosphorothioate degradation and may increase oxon impurity formation. Published data for this specific configuration is limited; manufacturers qualify mixing parameters through batch homogeneity studies and assay uniformity.

    Solid oral dosage incorporation is complicated by the oily state and requires sorption onto a high-surface-area carrier before blending. On production-scale fluid-bed granulators, fenthion is frequently adsorbed onto precipitated silica or calcium carbonate at 5–15 g API per 100 g carrier. The resulting free-flowing powder is milled to a particle size below 100 µm; a D50 of 40–70 µm is maintained to improve blend uniformity without generating excessive fines. Batch-to-batch variance in oil absorption can shift the angle of repose from 35° to 45°, altering compression fill weight. Rotary tablet presses operating at 8–12 kN compression force and 10–30 rpm turret speed are used for granulated material; direct compression is not recommended for high-load technical fenthion. For capsule products, the adsorbed API is filled into hard gelatin or HPMC capsules under 40–60% RH because higher humidity promotes tackiness and potential capsule softening.

    Specification Drivers, Residual Solvents, and Impurity Benchmarks

    Veterinary-grade fenthion API is differentiated from technical-grade material by stricter control of related organophosphorus impurities, residual solvents, and particulate contamination. The assay is expressed on dried basis; high-purity material typically requires fenthion content of 950–980 g kg⁻¹, though supplier-specific specifications vary. Related substances by HPLC area normalization include fenthion oxon, sulfoxide, sulfone, and trimethyl phosphorothioate impurities; total related substances are commonly limited to 2.0% area. Water content is controlled below 1.0 g kg⁻¹ to reduce hydrolysis during storage in sealed HDPE drums. Sulfated ash is limited to 0.5% w/w. Residual solvent profiles follow USP <467> or Ph. Eur. 5.4 for Class 2 and Class 3 solvents; toluene and xylene from synthesis steps are controlled at their respective limits. The API is stored at 5–30 °C in nitrogen-blanketed drums with desiccant-lined closures; storage above 30 °C increases formation of the oxon impurity.

    Typical veterinary-grade fenthion API control parameters
    ParameterAcceptance criterionAnalytical method designation
    Assay as fenthion, dried basis950–980 g kg⁻¹Validated reversed-phase HPLC
    Water content1.0 g kg⁻¹USP <921> Karl Fischer
    Loss on drying0.5% w/wUSP <731>
    Total related substances2.0% areaHPLC area normalization at 254 nm
    Sulfated ash0.5% w/wUSP <281>
    Heavy metals20 mg kg⁻¹Ph. Eur. 2.4.8 Method A
    Residual solventsClass 2/3 limitsUSP <467>

    For powders, granules, and premix, the dominant process risk is segregation. The API adsorbed on silica is pre-blended with lactose monohydrate or corncob grit in a double-ribbon mixer for 10–15 min. Final premix concentration is commonly 50 g kg⁻¹ or 100 g kg⁻¹ fenthion; this is diluted into feed at the target use level. Production-scale handling observations indicate that premature addition of fenthion oil before carrier sorption in a 1000 L ribbon mixer can produce agglomerates and assay RSD above 5% in top, middle, and bottom sampling points. A two-stage sorption process generally reduces blend RSD to below 2.5%. Granulation by low-pressure extrusion through a 4 mm die is performed at 45–55 °C product temperature; higher temperatures increase volatilization and oxon formation. Solutions are prepared as emulsifiable concentrates or ready-to-use topical sprays with 50–200 g L⁻¹ fenthion, using xylene or aromatic hydrocarbon solvents and nonionic/anionic emulsifier packages. The flash point of aromatic solvent-based formulations is typically 40–65 °C, so production areas must use ATEX-rated equipment under ATEX 2014/34/EU.

    When Fenthion Replaces Coumaphos, Diazinon, or Pyrethroid Actives in Ectoparasiticidal Formulations

    Compared with synthetic pyrethroid actives such as permethrin, fenthion offers a different mechanism of activity: metabolic oxidative desulfuration converts the parent phosphorothioate to the oxon, which then inhibits acetylcholinesterase. Unlike coumaphos, fenthion is a liquid at ambient temperature, which simplifies pour-on formulation but complicates solid oral dosage preparation. Its lipophilicity is higher than malathion and diazinon, reducing wash-off from treated hide under wet conditions but increasing environmental persistence. The downstream handling difference is not only pharmacological; technical fenthion has a viscosity in the range of 39–50 mPa·s at 25 °C, requiring gear pumps for accurate dosing into sealed mixers instead of the screw feeders used for crystalline organophosphates. The higher log P also changes sorption behavior on carriers, requiring higher-surface-area silica grades for adequate blend uniformity at equivalent premix concentrations.

    Manufacture under EU GMP Part II for active substances and FDA 21 CFR 211 for finished pharmaceuticals establishes batch traceability and contamination control. Several jurisdictions restrict use in food-producing animals or set mandatory withholding periods; fenthion is not suitable for emulsions at pH above 8.0, and contact with oxidizers, alkalis, or amines must be avoided because such exposures accelerate degradation and formation of more potent oxon metabolites. Because veterinary approvals are species-specific, formulation for tablets, injections, capsules, powders, granules, premix, or solutions must be supported by target animal safety, residue depletion, and efficacy data under the applicable regulatory framework. Published data for some species-formulation combinations is limited; a supplier certificate of analysis alone does not establish finished veterinary pharmacopoeial compliance or clinical equivalence.

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