| HS Code | 371567 |
| Chemical Name | 2,2-dichlorovinyl dimethyl phosphate (Dichlorvos, DDVP) |
| Molecular Formula | C4H7Cl2O4P |
| Molecular Weight | 220.98 g/mol |
| Cas Number | 62-73-7 |
| Appearance | Colorless to pale yellow clear liquid |
| Assay | ≥98.0% (veterinary grade) |
| Solubility | Sparingly soluble in water (approx. 8 g/L at 20°C); miscible with most organic solvents such as alcohols, ketones, aromatic and chlorinated hydrocarbons |
| Melting Point | -60°C |
| Boiling Point | 234°C at 760 mmHg (with decomposition); 140°C at 20 mmHg |
| Density | 1.415 g/cm3 at 25°C |
| Stability | Stable under normal conditions; hydrolyzes rapidly in alkaline media and slowly in neutral aqueous media; degraded by strong bases and UV light |
| Storage Conditions | Store in a cool, dry, well-ventilated area in tightly sealed, light-resistant containers; avoid moisture, alkali, and food/feed contamination |
As an accredited Dichlorvos (DDVP) 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 | Packaged in 25 kg sealed drums with tamper-evident closure, labeled for veterinary use, ensuring safe handling and stability. |
| Container Loading (20′ FCL) | 20′ FCL safely loaded with sealed drums/bags of DDVP API, stable, dry, ventilated, segregated from food/feed. |
| Shipping | Dichlorvos (DDVP) Veterinary Grade API ships in sealed, UN-approved containers, clearly labeled for hazardous materials. Transport complies with international regulations (IATA/IMDG/ADR) to prevent leakage or exposure. Handling requires protective equipment and cool, dry, ventilated conditions. Documentation includes Safety Data Sheets and certificates of analysis to ensure safe, compliant delivery worldwide. |
| Storage | Store Dichlorvos (DDVP) Veterinary Grade API in tightly sealed, original containers in a cool, dry, well-ventilated area, away from direct sunlight, heat, moisture, and open flames. Keep separate from food, feed, and incompatible materials like strong oxidizers or alkalis. Ensure the storage area is securely labeled, locked, and accessible only to authorized personnel. |
| Shelf Life | Shelf Life: 24 months from manufacture when stored in tightly closed original containers in a cool, dry place. |
In swine anthelmintic premix manufacture, dichlorvos is first adsorbed onto fumed silica at a 1:1 ratio by low-shear ribbon blending before introduction into the main carrier, since the API is a volatile organophosphate liquid with poor stability in alkaline environments. A stabiliser package of anhydrous citric acid and sodium dihydrogen phosphate is incorporated to maintain the granulation mass below pH 4.0; aqueous wet granulation is therefore replaced by a dry dispersion process or non-aqueous granulation using isopropanol. Production-scale horizontal ploughshare mixers with high-speed choppers operating at 3,000 rpm for 120 s are used to disperse API-loaded silica agglomerates through maize starch and lactose monohydrate. The finished premix is commonly standardised to 50 g/kg (5% w/w) dichlorvos and diluted at the feed mill or farm to 300–500 mg/kg complete feed, equivalent under typical intake to a single treatment window of 24–48 h. Blend uniformity is assessed at 10 sampling positions with a relative standard deviation not exceeding 5.0% according to Ph. Eur. 2.9.40; batch release also includes testing for residual solvents under VICH GL18 and elemental impurities under ICH Q3D. The terminal product is packed in 25 kg paper sacks with a polyethylene inner liner and labelled for discontinuous use only, because prolonged intake at these concentrations reduces plasma cholinesterase activity below 50% of baseline in treated pigs. In jurisdictions where the use in food-producing species remains authorised, withdrawal periods must be aligned with national residue depletion data; where no maximum residue limit is in force, the premix is restricted to non-food or environmental applications.
When unit dose falls below 25 mg, the formulation route for canine capsules and tablets must begin with geometric dilution because dichlorvos is not a dry crystalline powder suitable for direct compression. The API is first adsorbed onto colloidal silicon dioxide at a 1:10 ratio, then blended with microcrystalline cellulose and lactose monohydrate in a 1:10 second-stage dilution using a V-blender operating at 25 rpm for 20 min. Hard gelatin capsule fill weight is calibrated to 180–220 mg in size 3 shells, while tablet compression uses 8 mm round flat-faced tooling with a target hardness of 4–7 kp and friability below 1.0% per Ph. Eur. 2.9.7. Dissolution testing is carried out in 0.1 N HCl at 37 ± 0.5°C with paddle speed 50 rpm; the acceptance criterion is Q ≥ 80% at 45 min under USP <711>. The primary batch failure mode observed on commercial filling lines is migration of the liquid API into the gelatin shell when the powder blend is held outside controlled conditions; bulk blend holding time is therefore limited to 8 h, and the filling suite is maintained at 18–22°C with relative humidity not above 40%. Terminal product is packaged in PVC/aluminium blister packs with a desiccant sachet and labelled for companion-animal use only, since the low therapeutic index of dichlorvos makes food-producing species an unsuitable target. Pre-drying of the capsule shells at 45°C for 2 h is specified when ambient relative humidity exceeds 60%, and humidity indicator cards are included in bulk containers to verify packaging-line conditions.
| Dosage form | Target DDVP concentration | Critical equipment | Critical process control | Test standard |
|---|---|---|---|---|
| Swine feed premix granules | 50 g/kg (5% w/w) | Ploughshare mixer with high-speed chopper | Blend uniformity RSD ≤ 5% | Ph. Eur. 2.9.40 |
| Canine capsules | 10–25 mg per capsule | V-blender; automatic capsule filler | Bulk blend hold time ≤ 8 h | USP <711> |
| Equine oral pellets | 100 g/kg (10% w/w) | Twin-screw extruder; spheronizer | Barrel temperature ≤ 35°C | Ph. Eur. 2.9.12 |
| Injectable solution | Non-aqueous vehicle; water ≤ 0.5% w/w | Aseptic filling line; 0.22 µm PVDF filter | pH 4.0–5.0; nitrogen overlay | Ph. Eur. 2.6.1 |
| Poultry house solution | 20–50% w/w | Cold fogger; flat-fan hydraulic sprayer | Droplet VMD 20–40 µm | GC-FPD surface residue analysis |
Equine anthelmintic granules containing DDVP are manufactured by extrusion-spheronization rather than simple mesh granulation because the finished pellet must survive mastication and release the active organophosphate in the stomach. The granulation fluid is a non-aqueous binder solution of polyvinylpyrrolidone in isopropanol, added to a mixture of DDVP adsorbed on silica, oat hull fibre, and sodium starch glycolate. Extruder screen orifice diameter is 1.2 mm, spheronization speed is 800 rpm for 90 s, and drying is performed in a fluid-bed dryer at inlet air 40°C until loss on drying is ≤ 3.0%. The target concentration is 100 g/kg (10% w/w) dichlorvos, allowing a top-dress dose of 20 mg/kg bodyweight for strongyle and bot control based on historical equine anthelmintic use. Particle size is validated by sieve analysis according to Ph. Eur. 2.9.12; not less than 90% of the fraction is retained between 0.5 mm and 1.6 mm, and fines below 0.15 mm are limited to 5% to reduce dust exposure during handling. The terminal product is packed in high-density polyethylene tubs with induction-sealed foil lids, and the label states that the granules must not be mixed into sweet feed for more than 24 h. The major production bottleneck observed on commercial lines is die blockage caused by API-softened binder when screw temperature exceeds 35°C; barrel cooling with 10–15°C chilled water is therefore used continuously, and extruder torque is monitored as an early indicator of moisture variation in the feed blend.
Parenteral DDVP remains a narrow-indication presentation because the molecule undergoes rapid hydrolysis at pH above 5.5, and aqueous formulations are therefore unsuitable for routine sterile filling. For non-aqueous injectable solutions, the vehicle is typically propylene glycol or a mixture of glycofurol and dimethylacetamide; water content is controlled below 0.5% w/w by Karl Fischer titration at every bulk stage. Sterile filtration is carried out through 0.22 µm PVDF membranes at 20–25°C, and the solution is filled under nitrogen overlay into Type I amber glass ampoules to limit oxidative degradation. Pharmacopoeial testing includes visible particulate matter, sterility by membrane filtration according to Ph. Eur. 2.6.1, and related substances by HPLC with a single maximum impurity limit of 0.1% w/w for dichlorvos dimer or trimethyl phosphate. Terminal moist-heat sterilisation at 121°C for 15 min is generally avoided because it accelerates hydrolytic degradation and raises the related-substances profile; aseptic processing is therefore the default route. Residual solvent limits are applied under ICH Q3C, and the pH of the finished vehicle is adjusted to 4.0–5.0 with a non-aqueous acid buffer. The clinical limitation is the narrow cholinergic margin, and published data for this specific parenteral configuration is limited; any injectable product must be justified by species-specific pharmacokinetic data, and the label must state that accidental overdosage can produce cholinergic signs within 1–3 h because the API redistributes rapidly from plasma into tissues. The product must not be co-administered with other organophosphates, carbamates, or depolarising neuromuscular blockers.
In tunnel-ventilated poultry houses, DDVP solutions are applied as a space spray or residual barrier treatment for fly control where national biocidal product registrations permit. The concentrate is formulated at 20–50% w/w dichlorvos in an aromatic solvent or glycol ether carrier, with emulsifiers selected to produce a stable milky emulsion at 1:200 dilution in hard water up to 500 ppm calcium carbonate. Application equipment includes cold foggers with droplet volume median diameter between 20 µm and 40 µm and hydraulic compression sprayers with flat-fan nozzles calibrated to deliver 0.5–1.0 L of diluted product per 100 m² of wall surface or litter. Surface deposits are sampled by swabbing 100 cm² areas and analysed by gas chromatography with flame photometric detection; residual cholinesterase-inhibiting activity persists for 24–72 h under dry conditions but drops sharply when litter pH exceeds 8 or relative humidity exceeds 80%. The terminal product is packaged in 1 L and 5 L high-density polyethylene jerry cans with child-resistant closures, and the label includes a re-entry interval of 12 h for personnel and 24 h for birds under common national biocidal rules. The solution must not be applied directly to animals, feed, or drinking water, and it is incompatible with alkaline detergents because hydrolysis releases chloral and dimethyl phosphate degradation products. Published data for long-term surface persistence in deep-litter systems is limited, so the spray programme should be validated by repeated surface swabs rather than by visual fly count alone.
Because DDVP is active at milligram-level inclusion and is a cholinesterase inhibitor, multi-species feed mills require dedicated or validated clean-down procedures after production of any DDVP-containing premix. The compound is incompatible with alkaline carriers such as calcium carbonate and with moisture-releasing excipients; pre-drying of carriers at 105°C for 2 h is specified when ambient relative humidity exceeds 60%. Terminal powder premixes are mixed in double-cone blenders at 60% fill volume for 15 min, and cross-contamination limits in subsequent non-target feed are set at ≤ 0.5 mg/kg DDVP, verified by liquid chromatography-tandem mass spectrometry with a limit of quantification of 0.05 mg/kg. Cleaning validation uses swab recovery studies with an accepted recovery of ≤ 70% after correction, and the analytical method must be shown to be free from matrix interference in the presence of common feed antioxidants. The final powder is required to have a Hausner ratio of 1.25 or less; batches failing this flowability test are rejected from packaging lines because bridging in the filler hopper causes weight variation. The primary batch failure mode in dry weather is electrostatic adhesion of DDVP-loaded silica to stainless steel surfaces, which is controlled by maintaining relative humidity at 45–55% in the blending suite and by using conductive antistatic flooring. Terminal product is filled into valve-type paper sacks with batch-specific line clearance certificates, and the label prohibits simultaneous handling of DDVP premixes with aminoglycoside or pyrethroid concentrates due to the combined cholinergic and neurological risk during dust generation.
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Dichlorvos (DDVP) veterinary grade API is the 2,2-dichlorovinyl dimethyl phosphate active substance supplied for incorporation into tablets, injections, capsules, powders, granules, premixes, and solutions. The molecule carries CAS registry number 62-73-7, molecular formula C4H7Cl2O4P, and molecular weight 220.98 g/mol. At standard ambient conditions it is a mobile, colorless to pale-yellow liquid with density approximately 1.415 g/cm³ at 25 °C and a reported vapour pressure of 1.2 × 10⁻² mm Hg at 25 °C. The API is a direct-acting organophosphate cholinesterase inhibitor used in licensed veterinary medicinal products for the control of susceptible internal and external parasites in swine, equine, companion animal, and poultry applications where approved. Model designations are manufacturer-specific; codes such as DDVP-VET-API-100 or DDVP-VET-PREMIX-200 may be used to distinguish injectable-ready, oral-solid, and premix-compatible grades, but model codes do not replace the release specification for the intended dosage form.
Veterinary grade DDVP differs from technical insecticide material by the sum of controls applied to impurity profile, residual solvents, elemental impurities, and microbiological quality. A representative release setting for the veterinary API is an assay by gas chromatography with flame-ionization detection of 98.0–102.0% w/w on an anhydrous basis, whereas technical-grade DDVP may be sold against a minimum assay of 95.0% w/w with broad unspecified impurity attribution. Related substances including trichlorfon, 2,2-dichloroacetaldehyde, and trimethyl phosphate are limited individually to ≤0.50% by area normalization and in total to ≤1.00%. Residual solvents are controlled under ICH Q3C(R8); class 1 solvents are excluded, and class 2 solvents are limited according to the concentration limits of the guideline. Elemental impurities are controlled under ICH Q3D(R2), with acceptance limits derived from the intended route and daily dose. For injectable-grade material, bacterial endotoxin is evaluated by USP ⟨85⟩, and the product is released only when the endotoxin limit derived from the maximum labelled dose is met. Sterility is confirmed by USP ⟨71⟩ for parenteral presentations.
Manufacture of the veterinary API is expected to follow ICH Q7 or EU GMP Part II, with batch release based on a pharmacopoeial monograph where one exists and on the manufacturer’s certified specification. Because DDVP is a liquid at ambient temperature, the specification for oral solids does not include crystal form or polymorph identity; instead, the critical physical attributes are appearance, density, water content, and, after adsorption, the flow and blend properties of the carrier system.
Because the organophosphate ester linkage is base-sensitive, aqueous and semi-aqueous formulations are buffered to pH 4.0–5.5. Hydrolysis produces dimethyl phosphate and dichloroacetaldehyde; the latter can accelerate further degradation and is monitored as a degradation product in forced-degradation and stability protocols executed under ICH Q1A(R2). In solid formulations, residual moisture is controlled to ≤0.5% w/w for direct-compressible powders and to ≤1.0% w/w for some premix intermediates, with primary packaging composed of low-moisture vapour-barrier laminates and desiccant. The API is incompatible with alkaline excipients, amines, and oxidizing agents; contact with strong bases or nucleophilic buffers results in rapid assay loss and the formation of water-soluble organophosphate degradation products. Acidifying agents such as citric acid, fumaric acid, or tartaric acid may be used, but direct contact with strong acids is evaluated by forced degradation because dichloroacetaldehyde liberation can alter the impurity profile.
Parenteral DDVP formulations are confined to non-aqueous or low-aqueous vehicles because of the hydrolysis sensitivity described above. The API must meet the injectable-grade specification for endotoxin, sterility, and particulate matter; water content is limited to ≤0.5% w/w, and the finished injection is usually prepared in propylene glycol, polyethylene glycol 300–400, or glycofurol. The bulk solution is sterilized by filtration through a hydrophobic 0.22 μm membrane filter into presterilized vials, and subvisible particulate matter is controlled per USP ⟨788⟩ using the light obscuration method. Endotoxin limits are not a fixed API value; they are calculated from the maximum labelled dose and the target species, because endotoxin safety is dose-dependent and route-dependent. Production experience on small-volume parenteral lines shows that batch-to-batch viscosity variation in non-aqueous vehicles can shift filter throughput and filling accuracy; viscosity is therefore monitored at 25 °C with a cone-plate viscometer and held within a predefined range established during process qualification. Before sterile filtration, the bulk solution is checked for bioburden by membrane filtration with a limit of ≤10 CFU/100 mL; filter integrity is tested before and after use by bubble point or diffusion flow. The filling line operates under Grade A laminar airflow with Grade B background, following EU GMP Annex 1. The final product is tested for content uniformity by USP ⟨905⟩ and for related substances by a stability-indicating GC or HPLC method. Published data for specific DDVP injection formulations are limited; therefore, formulation-specific forced-degradation and compatibility studies are required before process scale-up.
In a typical manufacturing campaign for tablets and capsules, liquid DDVP is first dispersed onto a high-surface-area carrier such as precipitated silica, calcium silicate, or microcrystalline cellulose. The adsorbed concentrate is then blended with excipients in a ploughshare mixer or double-cone blender equipped with an intensifier bar. Carrier selection is based on oil absorption measured by ASTM D1483 or ISO 787-5; acceptable carriers for liquid retention typically exhibit oil absorption values in the range 200–300 mL/100 g, preventing exudation during shelf storage. Blend uniformity is assessed by assay of 10 stratified samples with acceptance limits of 90.0–110.0% label claim and relative standard deviation ≤5.0%. Tablet compression is performed at low compression force; hardness is maintained between 30 N and 70 N for immediate-release tablets, and disintegration time is limited to ≤15 min in 0.1 M hydrochloric acid or purified water according to the pharmacopoeial method. Magnesium stearate levels are limited to ≤1.0% w/w because hydrophobic lubricant can delay disintegration. Wet granulation is avoided because water accelerates hydrolysis; dry granulation by roller compaction is preferred for densifying the mixture. Capsule filling is conducted in humidity-controlled suites at relative humidity ≤30% and 18–22 °C, and hydroxypropyl methylcellulose capsules are used instead of gelatin to reduce moisture transfer.
For powders, granules, and premixes, process control is dominated by segregation, liquid migration, and moisture ingress. The liquid-loaded carrier is mixed into a dry base such as lactose monohydrate, wheat middlings, rice hulls, or calcium carbonate in a ribbon blender or paddle mixer. The carrier particle size is controlled by sieve analysis to a mean fraction of 100–500 μm; excessive fines promote segregation, while coarse carrier may reduce homogeneity. Premix production often uses a two-stage dilution: first a 1:10 intermediate premix is prepared, then diluted to the final concentration. Final premix moisture is maintained at ≤1.0% w/w, and the blend is discharged into antistatic liners to reduce dusting and electrostatic separation. Cleaning validation follows PIC/S PI 006-3 or equivalent national GMP guidance; because DDVP is a cholinesterase inhibitor, cross-contamination limits are set from permitted daily exposure on shared equipment.
| Quality attribute | Acceptance criterion | Test / standard |
|---|---|---|
| Assay, anhydrous basis | 98.0–102.0% w/w | GC-FID |
| Water content | ≤0.5% w/w injectable; ≤1.0% w/w oral solids | Karl Fischer |
| Related substances | Unspecified ≤0.20%; total ≤1.00% | GC-FID / HPLC-UV |
| Residual solvents | Class 1 excluded; Class 2 limits per ICH Q3C(R8) | Headspace GC |
| Elemental impurities | Class 1 not detected; Class 2 limits per ICH Q3D(R2) | ICP-MS |
| Bacterial endotoxins | Route-specific limit derived from dose | USP ⟨85⟩ |
| Sterility | Sterile for injectable products | USP ⟨71⟩ |
| Particulate matter | Parenteral limits | USP ⟨788⟩ |
| Dosage form | Critical process parameter | Typical control range | Test / standard |
|---|---|---|---|
| Oral solution | pH, assay, related substances | pH 4.0–5.5; assay 98.0–102.0% | Potentiometric, GC-FID |
| Injectable solution | Water content, particulate matter, sterility | ≤0.5% w/w; parenteral limits; sterile | Karl Fischer, USP ⟨788⟩, USP ⟨71⟩ |
| Tablet | Compression force, hardness, disintegration | Hardness 30–70 N; disintegration ≤15 min | Hardness tester, disintegration bath |
| Capsule | Fill humidity, shell, content uniformity | RH ≤30%; HPMC shell; 90.0–110.0% | Humidity logger, USP ⟨905⟩ |
| Powder / granule / premix | Blend uniformity, moisture, carrier particle size | RSD ≤5.0%; moisture ≤1.0% w/w; 100–500 μm | Stratified sampling, Karl Fischer, sieve analysis |
Analytical control for DDVP dosage forms requires a stability-indicating method that separates DDVP from dichloroacetaldehyde, trimethyl phosphate, and trichlorfon. Gas chromatography with a 5%-phenyl-methylpolysiloxane capillary column, 30 m length, 0.25 mm internal diameter, and 0.25 μm film thickness is one common configuration; helium is used at constant flow with a splitless injection and flame-ionization detection. The method is validated for specificity, linearity, accuracy, precision, and robustness according to ICH Q2(R1). For low-level impurity detection, liquid chromatography with tandem mass spectrometry may be applied when trichlorfon or dichloroacetaldehyde must be quantified below the flame-ionization detection limit. Process analytical technology in powder and premix lines may use near-infrared reflectance spectroscopy with a calibration model correlated to the GC assay; the model is revalidated when carrier lot or moisture content changes by more than the model’s calibration range.
Bulk liquid DDVP is stored in stainless steel or lined carbon steel drums under nitrogen, with moisture exclusion. Recommended long-duration storage is 2–8 °C; solidified or crystallized DDVP is not expected because the melting point is below ambient. Secondary packaging for solid premixes includes sealed low-density polyethylene liners with desiccant; desiccant selection is based on moisture sorption isotherm data. The API is not stored with alkalis, amines, or oxidizing agents, and is handled in closed transfer systems with local exhaust ventilation. Occupational exposure limits vary; the compound is a cholinesterase inhibitor, and industrial hygiene monitoring should follow national or ACGIH biological exposure indices for organophosphates.
Compared with trichlorfon, a phosphonate prodrug that undergoes non-enzymatic conversion to DDVP at alkaline pH, DDVP acts directly on acetylcholinesterase without metabolic activation. This difference influences delayed toxicity and species sensitivity. Compared with coumaphos or phosmet, DDVP has higher vapour pressure and shorter residual activity, reducing environmental persistence but requiring local exhaust ventilation and closed transfer in production suites. Against macrocyclic lactones such as ivermectin and moxidectin, DDVP has a narrower therapeutic index and a different parasite susceptibility profile; it is not regarded as interchangeable with endectocides. Regulatory status for DDVP veterinary use varies by jurisdiction, and published data for specific tablet, injectable, or premix formulations are limited where the product has been withdrawn from certain markets. Formulators should verify the current national pharmacopoeial monograph, the manufacturer’s certificate of analysis, and target-animal residue depletion guidance before developing any dosage form.
