| HS Code | 278469 |
| Productname | Malathion Solution Veterinary Grade API |
| Chemicalname | Diethyl 2-[(dimethoxyphosphorothioyl)sulfanyl]butanedioate |
| Casregistrynumber | 121-75-5 |
| Molecularformula | C10H19O6PS2 |
| Molecularweight | 330.36 g/mol |
| Appearance | Clear, colorless to pale amber liquid |
| Odor | Mercaptan- or garlic-like characteristic odor |
| Meltingpoint | 2.85 °C |
| Boilingpoint | 156-157 °C at 0.7 mmHg with decomposition |
| Density | 1.23 g/cm³ at 20 °C |
| Logpartitioncoefficient | 2.75 |
| Watersolubility | 145 mg/L at 20 °C |
| Organicsolubility | Soluble in alcohols, ketones, ethers, esters, and aromatic hydrocarbons |
| Assaypurity | ≥95.0% veterinary grade on dry basis |
| Stability | Stable in acidic and neutral media; hydrolyzes under strong alkaline conditions |
| Storageconditions | Store in tightly sealed, light-resistant containers in a cool, dry place below 25 °C |
| Shelflife | 24 months when stored under recommended conditions |
| Compatibledosageforms | Tablets, injections, capsules, powders, granules, premix, solutions |
As an accredited Malathion Solution 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 | Packaging: 25L HDPE drums, 200L drums, or custom quantities. Sealed containers with tamper-evident closures, labeled for veterinary API use. |
| Container Loading (20′ FCL) | One 20′ FCL container loaded with Malathion Solution veterinary grade API, packed in sealed drums, secured and labeled for safe transport. |
| Shipping | Ship as hazardous material under UN3082 (Environmentally hazardous substance, liquid, n.o.s.) in authorized, leak-proof containers. Label Class 9, marine pollutant. Keep upright, cool, dry, away from food and oxidizers. Use ground or sea freight; air limited. Include SDS, handling precautions, and spill kit. |
| Storage | Store in tightly sealed, original containers in a cool, dry, well-ventilated area away from direct sunlight, moisture, heat, and open flames. Maintain temperatures between 15–30°C. Keep away from oxidizing agents, acids, alkalis, and food/feed products. Ensure adequate ventilation and protect against physical damage to prevent leakage or contamination. |
| Shelf Life | Shelf life is typically 24 months from manufacture when stored in tight, light-resistant containers at controlled room temperature. |
Poultry dust-box formulations for Dermanyssus gallinae and Ornithonyssus sylviarum control in cage-layer and breeder houses load malathion solution onto inert mineral carriers at a target active concentration of 5.0% w/w. When the incoming veterinary-grade solution is 95.0% w/w malathion, the addition ratio is 5.26 kg of solution per 100 kg finished dust, with the balance composed of talc, calcium carbonate, and a 1.0–1.5% light mineral oil adhesion agent. Compliance for the finished dust falls under US EPA FIFRA 40 CFR Part 156 label requirements and residue limits under 40 CFR 180.111 where eggs or poultry meat may incur incidental contact, while the European Union classifies the product within Biocidal Products Regulation EU 528/2012, product type 18, requiring national authorization before placement on the market. The API itself is controlled to pharmacopoeial limits for malathion and its degradation impurities, including malaoxon and isomalathion, with residual solvent limits under ICH Q3C(R9) and VICH GL18. In production, the liquid API is first dispersed by geometric dilution into fumed silica at 2.0% w/w of the final batch to prevent agglomeration in a horizontal ribbon blender operated at 60–70% working volume and 15–20 rpm for 10–15 minutes; dust extraction must be rated for combustible mineral dusts because the carrier fraction can exceed 90% by mass. A known production bottleneck at relative humidity above 65% is moisture uptake by calcium carbonate, which shifts flowability and can cause bridging in rotary valve filling heads; pre-drying carriers to moisture below 0.2% and conditioning the blending room to 45–55% RH are commonly employed. The finished article is a 5% w/w malathion dust packaged in 12.5 kg and 25 kg bags or filled into poultry dust boxes, intended for direct application to birds and litter without food-contact surface use.
Whole-body spray concentrates for Bovicola bovis, Linognathus vituli, Solenopotes capillatus on cattle and Haematopuis suis on swine are normally supplied as 50% w/v emulsifiable concentrates. The addition ratio in the field tank is 1 part 50% EC to 99 parts water to yield 0.5% w/v active ingredient; for high-pressure cattle sprays, 0.25–0.5% w/v is typical, while swine mange sprays may use 0.5% w/v with a 5–7 day retreatment interval. Production of the EC involves dissolving malathion technical in an aromatic mineral oil fraction and pairing it with an anionic/nonionic emulsifier system at 8–12% w/v under high-shear rotor-stator mixing at 15–25 m/s tip speed; post-manufacture QC includes emulsion stability per CIPAC MT36, cold stability at 0°C, and accelerated storage at 54±2°C for 14 days. Water pH above 7.5 accelerates alkaline hydrolysis of the active, so tank water should be buffered to pH 5.0–6.5 with 0.02 M monobasic potassium phosphate; hard water above 300 mg/L CaCO₃ can destabilise the emulsion and should be softened before mixing. The terminal product is a 50% w/v malathion EC packaged in fluorinated HDPE containers of 1 gal and 2.5 gal, with a minimum re-emulsification stability of 30 minutes after dilution.
| Starting EC concentration (% w/v) | Dilution ratio (EC:water) | Final AI concentration (% w/v) | Example use window |
|---|---|---|---|
| 50 | 1:199 | 0.25 | Low-pressure cattle backline spraying |
| 50 | 1:99 | 0.5 | Whole-body adult bovine and swine spray |
| 50 | 1:49 | 1.0 | Unoccupied facility surface spray |
In companion animal topical lotion and pump-spray manufacturing, malathion solution is incorporated at a final active concentration of 0.5% w/v; for a 95.0% w/w technical incoming stream, this corresponds to 5.26 kg per 1,000 L finished lotion. The vehicle is typically a buffered hydroalcoholic system containing 20–40% w/w isopropyl alcohol and a thickening agent such as carbomer; neutralisation with triethanolamine must be avoided because elevated pH accelerates alkaline hydrolysis to malaoxon. Compliance for companion animal ectoparasiticides is split by jurisdiction: where the product is regulated as a veterinary medicinal product, VICH GL9 clinical trial data, VICH GL18 residual solvents, and pharmacopoeial API limits apply; where regulated as a pesticide, US EPA FIFRA 40 CFR 152 and EU BPR 528/2012 product type 18 govern registration. Process control relies on a high-shear homogeniser operating at 10–20 m/s tip speed for 15 minutes, followed by pH adjustment to 5.2–6.5 and viscosity stabilisation at 1,000–3,000 mPa·s. Feline applications are excluded from many registered label claims because organophosphate toxicity thresholds and grooming behaviour create a narrower safety margin; published data for this specific configuration is limited where cats are involved. The terminal product is a 0.5% w/v malathion lotion or pump spray in 100 mL and 500 mL containers, labelled for canine flea, louse, and mite control without systemic administration.
Malathion solution can be deposited onto granular carriers for house fly Musca domestica and stable fly Stomoxys calcitrans larviciding in accumulated manure and moist bedding. The addition ratio for a 2.0% w/w finished granule is 2.105 kg of 95.0% w/w technical malathion per 100 kg carrier. The production process uses a rotary coater or ribbon mixer fitted with spray bars; the liquid is diluted with a non-aqueous solvent to reduce viscosity and enhance even distribution, with bed temperature maintained below 40°C because thermal oxidation accelerates malathion degradation. Absorbency differences between attapulgite and corn cob carriers create batch-to-batch variation: attapulgite has higher oil absorption and provides more uniform loading, while corn cob may require pre-drying at 45°C for 30 minutes before spray loading to avoid clumping in the coater. Compliance is anchored to US EPA FIFRA 40 CFR Part 156 use directions for non-food agricultural premises and EU BPR 528/2012 product type 18, with surface water run-off restrictions defined at the national level. The finished article is a 2% w/w malathion granular larvicide packaged in 25 kg multi-wall bags, intended only for deep-pit manure systems, spilled feed piles, and moist bedding accumulations; broadcasting onto saturated ground or areas hydrologically connected to surface water is operationally unsound and generally excluded from registered labels.
Residual surface sprays for animal transport trailers, poultry house floors, and concrete feedlot aprons are prepared from 50% w/v EC by dilution of 1 part EC to 49 parts water, yielding a nominal 1.0% w/v active solution. The finished solution is not approved for food-contact surfaces; treated trailers should stand unoccupied and ventilated before animal re-entry, and feed troughs must be covered during application. Compliance for this use track is driven by US EPA FIFRA 40 CFR 156.10 label directions, occupational exposure limits under OSHA 29 CFR 1910.1200, and EU BPR 528/2012 product type 18 where national authorisation exists. Downstream manufacture of the ready-to-use solution uses an agitated blending tank with pH adjustment to 5.0–6.5 via 0.02 M monobasic potassium phosphate, followed by filtration through a 50 µm mesh to prevent nozzle blockage. Field spray equipment should be air-induction flat-fan nozzles operated at 2–3 bar, producing spray droplets with Dv90 ≤ 150 µm to reduce drift onto adjoining pens or pasture. The terminal package is a 1.0% w/v malathion residual surface spray in 1 gal, 5 gal, and 55 gal containers.
| Jurisdiction | Standard / regulation | Test or requirement |
|---|---|---|
| United States | 40 CFR 180.111 | Residue tolerance for malathion in food/feed contact commodities |
| United States | 40 CFR 156.10 | Label content, precautionary statements, use directions |
| European Union | EU BPR 528/2012 PT18 | Active substance approval and product authorization for insecticides/acaricides |
| Pharmaceutical GMP | 21 CFR 211 / ICH Q3C(R9) | Finished drug CGMP and residual solvents |
| VICH | VICH GL18 | Residual solvents in veterinary medicinal products |
Backrubber and oiler stations for Bos taurus and Bos indicus horn fly Haematobia irritans and lice control use oil-based concentrates rather than aqueous sprays because the wick surface must remain lipophilic and slow-drying. The addition ratio is 1 part 50% w/v EC to 24 parts mineral oil, yielding 2.0% w/v malathion in the charging fluid. The diluent is a 40–60 cSt naphthenic or paraffinic mineral oil; oil viscosity below 30 cSt causes excessive run-off from wick surfaces and above 100 cSt reduces capillary wicking in cotton wicks, leaving dry zones that do not transfer active. Manufacturing uses a low-shear paddle mixer at 30–60 rpm for 30 minutes; no heating is introduced because malathion degrades with prolonged thermal load. Moisture content is controlled below 0.1% to avoid hydrolysis and phase separation, and the blend is filtered through a 75 µm screen before filling. Compliance is governed by US EPA FIFRA 40 CFR 152 registration for the final pesticide product and 40 CFR 156.10 precautionary colour and labelling requirements; in jurisdictions where the oiler charge is treated as a veterinary pharmaceutical, 21 CFR 211 CGMP and ICH Q3C(R9) residual solvent limits apply. The terminal product is a 2.0% w/v malathion backrubber oil concentrate packaged in 1-quart and 1-gallon fluorinated HDPE containers, to be added to clean reservoir oilers only after the oiler wick has been saturated with plain mineral oil to avoid dry-wick overloading.
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Malathion Solution Veterinary Grade API is supplied as a standardised liquid concentrate of diethyl (dimethoxythiophosphorothioylthio)succinate, CAS 121-75-5, with a molecular formula C10H19O6PS2 and a relative molecular mass of 330.36. The product is offered in nominal solution strengths of 95.0% w/w and 50.0% w/w malathion in specified non-aqueous carriers; the exact model designation is assigned by the manufacturer according to carrier type and declared concentration. Typical physical properties for the 95.0% w/w solution include a density of approximately 1.23 g/cm³ at 25 °C, a refractive index of 1.4960–1.5020 at 20 °C, and a flash point above 100 °C in closed-cup testing when high-boiling carriers are used. The material is intended as the active-substance input for licensed veterinary medicinal products in tablet, injection, capsule, powder, granule, premix, and solution presentations. Unlike agricultural emulsifiable concentrates, veterinary-grade API is released with a documented impurity profile, a residual solvent statement aligned with VICH GL18 or ICH Q3C, and batch data for assay, water content, acid value, and organophosphorus-related compounds. Published data for malathion as a veterinary active substance is narrower than for agricultural applications; therefore, each formulation project should establish product-specific compatibility, recovery, and stability data.
Release specifications for veterinary-grade malathion solution should include assay by gas chromatography with flame-ionisation detection, expressed as 95.0%–102.0% w/w on the anhydrous, solvent-free basis, unless a lower declared concentration is justified in the marketing authorisation dossier. The total related organophosphorus substance limit is commonly set at not more than 2.0%, with specified impurities—malaoxon, isomalathion, and the O,O,S-trimethyl phosphorodithioate analogue—limited individually to not more than 0.5%. These thresholds are more stringent than those accepted for agricultural technical material, where solvent and emulsifier burdens may be unspecified. Veterinary API should also provide a water content of not more than 0.1% by Karl Fischer titration and a non-volatile residue consistent with the declared carrier. Residual solvents are assessed by headspace gas chromatography according to USP <467> or Ph. Eur. 2.2.28; xylene, toluene, and ethylbenzene should be absent unless declared and controlled to the permitted daily exposure limits established by VICH GL18. Because malathion is susceptible to hydrolysis and oxidation, the certificate of analysis should also report acid value and peroxide value where the carrier contains unsaturated esters.
| Parameter | Veterinary-grade solution API | Agricultural technical concentrate |
|---|---|---|
| Assay | 95.0–102.0% w/w on solvent-free basis | 90–95% technical, variable by batch |
| Water content | ≤ 0.1% | not routinely controlled |
| Related organophosphorus compounds | total ≤ 2.0%; specified impurities ≤ 0.5% | not always reported |
| Residual solvents | limited by VICH GL18 | xylene or alkylbenzene solvent may be present |
| Documentation | full certificate of analysis with impurity profile | basic certificate of analysis |
Because malathion is a liquid active substance, conversion into solid oral dosage forms depends on carrier selection and adsorption capacity. Precipitated silica with a mean particle size below 50 µm and oil absorption above 200 g/100 g is used on production-scale ribbon blenders to convert liquid malathion into free-flowing powders; the liquid-to-carrier ratio is typically between 1:1.5 and 1:4 w/w. The resulting admixture should be evaluated for angle of repose, compressibility index, and flow through a 10 mm orifice. Direct compression is generally limited by the oily nature of the adsorbed liquid; wet granulation with a binder solution of polyvinylpyrrolidone in isopropanol provides better content uniformity for tablets. The granulation endpoint should be controlled by moisture content below 2.0% and by sieve fraction above 75 µm not exceeding 30% of total mass. For capsule filling, the adsorbed powder is often blended with microcrystalline cellulose and croscarmellose sodium to reduce sticking and improve disintegration. These process parameters are not monograph requirements; they are derived from general pharmaceutical processing practice, and published data for malathion in each specific configuration is limited.
For injection formulations, malathion solution should be dissolved in a non-aqueous vehicle such as benzyl alcohol-ethyl oleate mixtures or medium-chain triglycerides. Aqueous systems are not recommended because hydrolysis to the mono-acid metabolite is rapid in neutral-to-alkaline conditions; if short-term aqueous dilution is unavoidable, the pH should be maintained between 3.0 and 5.0. Parenteral products should be evaluated for peroxide value and free fatty acid content of the oil vehicle. Terminal steam sterilisation at 121 °C for 15 min may degrade malathion; aseptic filtration or dry heat sterilisation of the vehicle before compounding is preferred. For solutions and premixes, the API may be diluted in propylene glycol or medium-chain triglyceride vehicles; the finished product should be checked for clarity at 2–8 °C and 25 °C to detect crystallisation or phase separation. For powder and granule premixes, malathion is typically sprayed onto a feed carrier such as corncob grits or lactose monohydrate in a paddle mixer; the target coefficient of variation for malathion content across 10 sampling points should be below 5.0% before release. Mixer speed, spray rate, and hold time must be controlled because uneven distribution of a liquid active substance can produce super-potent and sub-potent pockets in the finished premix.
In high-shear granulation, addition of the liquid API before the binder solution may generate tacky agglomerates that arrest impeller rotation. Production-scale high-shear mixers with impeller tip speeds above 5 m/s and chopper speeds above 1,500 rpm should be operated with the liquid API pre-adsorbed onto silica or lactose to avoid oil film formation on bowl surfaces. Residual moisture after drying should be kept below 2.0% because water accelerates hydrolysis of malathion to the mono-acid derivative. Dryer inlet air temperature should not exceed 50 °C; fluidised-bed drying of a malathion-containing granule should include gas chromatography assays at the start and end of drying to quantify volatile losses. Thermal degradation can generate malaoxon, which has substantially higher acetylcholinesterase inhibition potency than the parent compound; process validation should therefore include an assay for malaoxon in the dried granule and finished tablet, with an acceptance limit not more than 0.5% of the malathion content.
Malathion differs from other organophosphate active substances in its mammalian detoxification pathway. Unlike coumaphos, which is largely restricted to cattle and poultry applications due to its higher acute toxicity, malathion is inactivated by mammalian carboxylesterases to the mono-acid metabolite, resulting in a lower acute oral toxicity in rats, with published LD50 values generally reported in the range 1,000–5,500 mg/kg body weight depending on vehicle and strain. This therapeutic margin must not be extrapolated to cats or birds without species-specific data, because feline esterase activity is lower and avian species may be more sensitive. Compared with diazinon, malathion has a shorter environmental half-life under field conditions, but its odour profile is generally considered more acceptable in premises and dairy housing. Against arthropods, malathion requires metabolic activation to malaoxon; therefore, onset of knockdown may be slower than that of phoxim or synthetic pyrethroids. Cross-resistance to other organophosphates may be present in populations of Haematobia irritans and Psoroptes ovis; a validated susceptibility test should be performed before selecting malathion as a replacement for coumaphos or diazinon in a control programme.
| Test | Analytical technique | Reference basis |
|---|---|---|
| Assay | Gas chromatography with flame-ionisation detection | Pharmacopoeial monograph, where available |
| Related organophosphorus compounds | Gas chromatography with flame-photometric detection or liquid chromatography | Batch-specific specification |
| Residual solvents | Headspace gas chromatography | USP <467> / Ph. Eur. 2.2.28 |
| Water content | Karl Fischer titration | Ph. Eur. 2.5.12 |
| Residual solvent limits in veterinary products | Documentation review | VICH GL18 |
Storage of malathion solution API in epoxy-phenolic-lined steel drums or fluorinated polyethylene containers is preferred; unlined carbon steel is unsuitable because trace moisture and acidic hydrolysis products may generate corrosion and metal-catalysed degradation. The product should be stored at or below 25 °C in a dry, ventilated warehouse. Repeated partial withdrawal from a single container should be avoided because headspace air may introduce moisture and accelerate hydrolysis. Under these conditions, a retest interval of 12 months is commonly assigned, with extension based on annual assay, water content, and related substances data. For material transferred into smaller process containers, the holding time at ambient temperature should not exceed 72 h unless inert-gas blanketing is applied. Material from damaged containers should be tested for water content, acid value, and malaoxon before use in manufacturing.