| HS Code | 268828 |
| Product | Dimetridazole Veterinary Grade API |
| Chemicalname | 1,2-dimethyl-5-nitroimidazole |
| Casnumber | 551-92-8 |
| Molecularformula | C5H7N3O2 |
| Molecularweight | 141.13 g/mol |
| Appearance | White to pale yellow crystalline powder |
| Meltingpoint | 138-141°C |
| Solubility | Slightly soluble in water; soluble in acetone, chloroform, ethanol and dilute mineral acids |
| Relatedsubstances | Meets veterinary pharmacopoeia requirements |
| Assayondriedbasis | 98.0% to 101.0% |
| Storage | Keep in well-closed containers, protected from light |
| Intendeddosageforms | Tablets, injections, capsules, powders, granules, premix and solutions |
As an accredited Dimetridazole 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 | Dimetridazole Veterinary Grade API in 25 kg double-polythene-lined fiber drums. For tablets, injections, capsules, powders, granules, premix, solutions. |
| Container Loading (20′ FCL) | One 20-foot FCL loaded with sealed drums/bags of Dimetridazole veterinary API, palletized and secured for safe transport. |
| Shipping | Dimetridazole Veterinary Grade API ships in sealed, tamper-evident drums or bags, protected from moisture and light. Handling requires PPE and strict adherence to veterinary pharmaceutical regulations. Transport follows hazardous material guidelines, ensuring safe, temperature-controlled delivery to manufacturing facilities worldwide. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature, protected from light, moisture, and direct sunlight. Keep containers tightly closed and sealed when not in use. Avoid contact with strong oxidizers or acids. Ensure strict segregation from food and animal feed. Follow local regulations for safe handling and disposal. |
| Shelf Life | Shelf life is typically 24 months from manufacture when stored in a cool, dry, dark place in tightly sealed containers. |
In feed-mill receiving areas where dimetridazole veterinary-grade API enters a downstream medicated premix line, the first processing decision is not assay release but the pre-blend carrier sequence, because direct addition of micronised API into a ribbon blender against a low-density corn cob carrier creates segregation paths that cannot be corrected by extended blend time alone. The API is pre-screened through 500 μm mesh and geometrically diluted with a carrier such as lactose monohydrate or corn cob meal before being transferred to a 300 kg ribbon blender; this step limits assay variability arising from dead zones at the blender ends and from dust entrainment during top-loading. A typical intermediate premix is formulated at 200 g/kg (20.0% w/w) dimetridazole with colloidal silicon dioxide at 5 g/kg as flow aid and carrier q.s. to 1 kg; when 1.0 kg of this premix is incorporated into 1000 kg finished feed, the final concentration reaches 200 mg/kg, and the working range in registered poultry programs is 150–200 mg/kg. After blending for 12 min, the batch is discharged through a 500 μm sieve into multiwall paper bags with an inner polyethylene liner; moisture is held at ≤ 0.5% by Ph. Eur. 2.2.32, and packaging is performed at < 55% RH to prevent hygroscopic caking. Terminal product type is a medicated premix powder or granular intermediate for feed mill incorporation.
Compliance for this premix configuration is anchored to assay by Ph. Eur. 2.2.29 with release limits 98.0–102.0% on dried basis, microbial enumeration and specified organisms by Ph. Eur. 2.6.12/2.6.13, elemental impurities by ICH Q3D, and API GMP by ICH Q7. Jurisdictional limits are critical: EU Regulation No 37/2010 does not establish a maximum residue limit for dimetridazole in food-producing species, and 21 CFR 530.41 prohibits extralabel use of nitroimidazoles in food animals in the United States; therefore this premix scenario is operable only where a national registration explicitly permits the target food-producing species and defines a withdrawal period. Production-scale failure mode is batch-to-batch segregation when the API is not pre-diluted or when the blender is filled above 70% of working volume; the required corrective action is a two-stage geometric dilution and post-mix sampling from 10 defined points before discharge.
Wet granulation of a 250 mg/g water-soluble powder requires the granulating fluid to be acidified before introduction of the API, because neutral pH produces incomplete dissolution and leaves a non-uniform active fraction after drying. A registered drinking-water formulation may contain dimetridazole 250 g/kg, anhydrous citric acid 120 g/kg, povidone K30 20 g/kg, and lactose monohydrate q.s. to 1 kg; after reconstitution of 100 g powder in 10 L water, the concentrate is diluted into the medicated drinking water line at the prescribed final dose. Granulation is performed in a fluid-bed dryer with top-spray at inlet air 60–65 °C, product temperature 35–40 °C, and final loss on drying ≤ 1.5% by Ph. Eur. 2.2.32; the dried granulate is passed through 710 μm and 150 μm sieves to retain the 150–710 μm target fraction. Release testing includes dissolution by Ph. Eur. 2.9.3 in 900 mL water at 37 °C with a specification of Q = 80% in 30 min, assay by Ph. Eur. 2.2.29, microbial limits by Ph. Eur. 2.6.12/2.6.13, and residual solvents by ICH Q3C. The terminal product is a water-soluble powder for reconstitution into an oral solution; this presentation is typically restricted to non-food species or to jurisdictions where water medication for food-producing species remains expressly authorised.
The decision to terminally sterilise a 100 mg/mL dimetridazole injection at 121 °C for 15 min forces the formulation outside the simple aqueous zone, because the API is sparingly soluble at neutral pH and may precipitate if the pH drifts above 6.0 during buffer hold or after autoclave cooling. A typical parenteral presentation contains dimetridazole 100 g, propylene glycol 400 g, benzyl alcohol 20 g, citric acid monohydrate to pH 4.5–5.5, and water for injection q.s. to 1 L. The solution is compounded in a closed stainless steel vessel with nitrogen sparging, pre-filtered through 0.45 μm and sterile-filtered through 0.22 μm polyethersulfone filters, filled into 100 mL Type I glass vials, and loaded into a steam autoclave for terminal sterilisation. The terminal product is a sterile injectable solution for prescription use in non-food species or in jurisdictions where a parenteral veterinary medicine containing dimetridazole is specifically registered. Operational boundary: the solution is incompatible with alkaline rinse media and should not be held at pH > 6.0 for more than 4 h; published data for this specific configuration is limited.
| Test parameter | Standard code | Specification anchor |
|---|---|---|
| Sterility | Ph. Eur. 2.6.1 | No growth after 14 days |
| Bacterial endotoxins | Ph. Eur. 2.6.14 | Limit defined by marketing authorisation |
| Particulate contamination | Ph. Eur. 2.9.19 | Sub-visible particle counts per monograph |
| Assay | Ph. Eur. 2.2.29 | 95.0–105.0% of label claim |
| pH | Ph. Eur. 2.2.3 | 4.5–5.5 |
Tablet manufacturing for dimetridazole products in non-food species such as racing pigeons and ornamental birds requires direct compression rather than wet granulation, because the heat and moisture exposure in a fluid-bed or high-shear wet granulation step can reduce assay and increase unspecified degradant peak area. A 105 mg strength tablet with total mass 350 mg may contain microcrystalline cellulose 50.0% w/w, crospovidone 5.0% w/w, colloidal silicon dioxide 0.5% w/w, and magnesium stearate 0.5% w/w; the API is pre-screened through 180 μm mesh and blended for 10 min in a bin blender before compression on a rotary tablet press. Hardness is set at 50–80 N, friability is controlled at ≤ 1.0% by Ph. Eur. 2.9.7, and disintegration is ≤ 15 min in water at 37 °C by Ph. Eur. 2.9.1. Uniformity of mass is tested by Ph. Eur. 2.9.5, content uniformity by Ph. Eur. 2.9.6 or Ph. Eur. 2.9.40, and assay by Ph. Eur. 2.2.29. The terminal product is an immediate-release tablet for prescription administration in non-food species; in food-producing animals, the same prohibition under 21 CFR 530.41 and the absence of a Union maximum residue limit apply.
Low-dose dimetridazole capsule filling at 50 mg API per 200 mg fill weight in a size 3 hard gelatin capsule requires particle size control and frequent fill weight verification, because the API crystals tend to adhere to stainless steel contact surfaces and produce drift during extended tamping pin or dosator runs. The formulation addition ratio is 25.0% w/w dimetridazole, anhydrous lactose 74.0% w/w, and magnesium stearate 1.0% w/w; the API and lactose are co-screened through 250 μm mesh and blended for 8 min in a bin blender before encapsulation. Process verification includes fill weight checks at 15-min intervals, empty capsule moisture at 13–16% to prevent splitting or shrivelling, and metal detection with ferrous, non-ferrous, and stainless steel test pieces at 1.5 mm. Compliance anchors include uniformity of mass by Ph. Eur. 2.9.5, uniformity of dosage units by Ph. Eur. 2.9.40 with acceptance value AV ≤ 15.0, dissolution by Ph. Eur. 2.9.3 where registered, and assay by Ph. Eur. 2.2.29. The terminal product is a hard gelatin capsule for non-food species; food-producing species are excluded in the same manner as the premix and tablet scenarios.
Dry granulation by roller compactor is selected over wet massing for oral granules containing 200 mg/g dimetridazole when downstream users require a dust-free, free-flowing intermediate that can be metered into feed, dosed into water, or filled into sachets for oral administration. The API is mixed with microcrystalline cellulose 300 g/kg, croscarmellose sodium 50 g/kg, and colloidal silicon dioxide 5 g/kg; the blend is compacted at roller pressure 4–6 MPa and screened through 1000 μm mesh to retain a granule fraction between 250 μm and 1000 μm. The addition ratio in the final granule is 200 mg/g (20.0% w/w), and the granules are packed into 25 kg drums or unit-dose sachets. Compliance anchors for non-sterile granules include loss on drying by Ph. Eur. 2.2.32 with limit ≤ 1.5%, microbial enumeration and specified organisms by Ph. Eur. 2.6.12/2.6.13, assay by Ph. Eur. 2.2.29, and elemental impurities by ICH Q3D. The terminal product is an oral granule intermediate for dose titration in non-food species or in registered food-producing species where national withdrawal period controls specifically permit it. Operational boundary: recompaction of fines above 30% of batch mass should be avoided because repeated compaction increases granule hardness and reduces dissolution rate; published data for this specific configuration is limited.
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Dimetridazole veterinary-grade API is a 1,2-dimethyl-5-nitroimidazole derivative with CAS registry number 551-92-8, molecular formula C5H7N3O2, and molecular weight 141.13 g/mol. The active substance is supplied as a white to pale yellow crystalline powder or granular premix and is offered in three physical grades: a standard crystalline grade having a d90 typically below 150 µm, a micronized grade with a d90 below 25 µm for aqueous suspension and injectable co-solvent processing, and a granular premix grade with a target retention of 80% between 250 µm and 710 µm. Supply-chain designations DMZ-VET-S, DMZ-VET-M, and DMZ-VET-G correspond to the standard, micronized, and granular premix grades respectively. The release specification is based on an assay on the dried basis of 98.0–101.0% and a melting range of 138–141 °C. The API is intended for tablets, injections, capsules, powders, granules, premix feeds, and solutions where national regulatory authorisation exists. Compared with metronidazole, dimetridazole lacks the hydroxyethyl side chain; this structural difference lowers aqueous solubility, raises the melting point, and alters susceptibility patterns among anaerobic protozoa, requiring different excipient strategies in finished dosage forms.
Because several pharmacopoeial monographs for dimetridazole have been archived, release specifications are usually derived from manufacturer methods and legacy veterinary monographs. A typical specification set for the non-sterile oral and premix grades includes the parameters shown below. Parenteral grade additional controls are addressed separately because they require bacterial endotoxin and particulate matter testing.
| Parameter | Acceptance criterion | Method |
|---|---|---|
| Appearance | white to pale yellow crystalline powder | visual inspection |
| Identification | retention time within ±0.2 min of reference; infrared spectrum concordant | HPLC with UV detection at 310 nm; ATR-FTIR |
| Assay on dried basis | 98.0–101.0% | HPLC area normalisation |
| Loss on drying | ≤0.5% after 105 °C for 2 h | oven drying |
| Melting range | 138–141 °C | capillary method |
| Total related substances | ≤1.0% | HPLC |
| Residue on ignition | ≤0.1% | muffle furnace 600 °C |
| Heavy metals | ≤10 ppm | ICP-MS |
| Particle size, micronized grade | d90 ≤25 µm; d50 8–15 µm | laser diffraction |
| Bulk density | 0.45–0.65 g/cm³ | USP <616> Method I |
| Tapped density | 0.60–0.80 g/cm³ | USP <616> Method II |
| Residual solvents | conforms to ICH Q3C Option 1 limits | headspace GC |
The specification above is a starting point; residual solvent profiles vary with the recrystallisation solvent and should be verified by headspace gas chromatography against the intended monograph or marketing authorisation. The micronized grade is not interchangeable with the standard grade without revalidation of blend uniformity because particle size reduction changes both electrostatic charging and the surface-to-mass ratio.
Dry blending of the standard crystalline grade with colloidal silicon dioxide at 0.5–1.0% w/w and a low-dusting diluent is used to reduce cohesiveness in capsules and powders. Segregation becomes process-limiting when the active-to-excipient particle size ratio exceeds approximately 4:1; in low-dose premixes, direct blending is therefore replaced by wet granulation or adsorption onto a carrier. In a 100 kg ribbon blender, blend uniformity should be verified by sampling at ten points, with a coefficient of variation not exceeding 5.0%. Published data for this specific configuration is limited; pilot-scale confirmation under the intended feed matrix and packaging conditions is required before routine manufacture.
Particle size distribution governs both blend homogeneity and segregation risk on mineral or vegetable carriers. The granular premix grade is designed for addition to ground maize, wheat middlings, or calcium carbonate at historical final-feed inclusion rates of 0.0125% to 0.05%. At these concentrations, a 1 kg finished feed sample may contain only 125–500 mg of active; therefore oil lubrication at 1–2% w/w or binder agglomeration is needed to stabilise the active on the carrier. Fluidised-bed agglomeration of micronized dimetridazole onto lactose monohydrate with povidone K30 at 1.5–2.5% binder solids reduces dusting, but the inlet air temperature should be maintained at 50–60 °C to remain safely below the melting range of the API. Sieve analysis of the granulated material at 75 µm, 150 µm, and 250 µm controls fines generation; excess fines below 75 µm should not exceed 10% of the batch because electrostatic dust increases cross-contamination risk during transfer and packaging. The crystalline material is brittle under high-shear milling, and micronisation can generate charged particles that adhere to stainless steel contact surfaces unless relative humidity is held at 40–50% and equipment grounding is used.
Tablet and capsule manufacture uses wet granulation or roll-compaction when the active exceeds 10% of the core weight. Direct compression of the unprocessed crystals may produce capped tablets because the API exhibits limited plastic deformation. On a 10-station rotary press, a precompression force of 2–4 kN and a main compression force of 8–14 kN are typical starting points for a 200 mg core containing 25 mg dimetridazole. Friability is assessed according to USP <1216> with acceptance of not more than 1.0% weight loss after 100 rotations. Capsule filling requires granule flow with a Carr index below 25%; the bulk and tapped density limits in the specification table are intended to maintain a Hausner ratio between 1.20 and 1.30. Immediate-release tablet disintegration is tested in 0.1 M hydrochloric acid at 37 °C, with an acceptance of 15 min for uncoated cores. Dissolution testing in 900 mL of 0.1 M hydrochloric acid using USP Apparatus II at 50 rpm is used to compare formulation variants; published data for a compendial dissolution monograph is limited.
Injectable presentation of dimetridazole is constrained by the low aqueous solubility of the free base, reported as approximately 2.4 g/L at 25 °C. The molecule behaves as a weak base; dissolution increases in acidified vehicles through protonation of the imidazole ring. A developmental injectable vehicle may combine propylene glycol at 20–40% v/v, ethanol at 5–10% v/v, and water for injection, adjusted with hydrochloric acid to pH 3.5–4.5. The low pH maintains the active in solution but can hydrolyse ester-based co-solvents; benzyl alcohol at 1–2% v/v is used only in multidose preparations where the target species and route permit it. Terminal sterilisation at 121 °C for 15 min is not uniformly applicable because nitroimidazoles can undergo pH-dependent degradation at elevated temperature. Sterile filtration through a 0.22 µm PVDF membrane is preferred for heat-labile presentations, with a 0.45 µm prefilter to reduce membrane load. Parenteral grade dimetridazole should carry a bacterial endotoxin limit not exceeding 0.5 EU/mg and be tested according to USP <85>; particulate matter acceptance follows USP <788> for large-volume parenterals or USP <789> for small-volume parenterals. Photostability should be assessed according to ICH Q1B; dilute aqueous solutions are highly sensitive to ultraviolet light, and amber glass primary packaging is used when the product is exposed to light during storage or administration.
Water-soluble powders and oral solutions for drinking water application require rapid reconstitution and resistance to precipitation in hard water. The free base distributes poorly into water above pH 7.0; acidification with citric acid to pH 3.0–3.5 and inclusion of a wetting agent at 0.1–0.5% w/w improves dissolution. Published data for reconstitution in field water of varying carbonate hardness is limited; formulation trials should include water at 250 ppm and 500 ppm calcium carbonate hardness to confirm that the target dose remains in solution for 24 h in the drinking water distribution system. Effervescent granules based on sodium bicarbonate and citric acid must be protected from moisture because carbon dioxide release in the presence of free water can pressurise bulk packaging. Solutions prepared with simple syrup or sorbitol carriers require antimicrobial preservation according to the intended storage period; sodium benzoate at 0.1% w/v is commonly evaluated under challenge testing, but compatibility with acidified vehicles must be confirmed.
Control of low-dose premix and solution feed formulations requires an extraction and HPLC method with adequate sensitivity. Acidified aqueous extraction with a C18 column and detection at 310 nm provides a limit of quantitation below 0.1 mg/kg in finished feed when the extraction volume and injection volume are optimised. Recovery from feed matrices can be affected by mineral carriers and oil binders; method validation should cover spike levels at 50%, 100%, and 150% of the labelled concentration. Mass confirmation of positive samples is performed by LC-MS/MS, because some natural feed components may interfere with ultraviolet detection at low concentrations.
Dimetridazole differs from metronidazole and ronidazole in the substitution pattern on the imidazole ring. These structural features affect solubility, absorption, and the range of susceptible anaerobic protozoa. The table summarises the principal physicochemical and regulatory distinctions.
| Property | Dimetridazole | Metronidazole | Ronidazole |
|---|---|---|---|
| Substituent | 1,2-dimethyl-5-nitroimidazole | 1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole | 1-methyl-5-nitroimidazole-2-methyl carbamate |
| Aqueous solubility at 25 °C | 2.4 g/L | 10.0 g/L | published data limited |
| Melting range | 138–141 °C | 159–163 °C | 168–171 °C |
| Primary veterinary targets | Histomonas meleagridis, Trichomonas gallinae | Giardia, Trichomonas, anaerobic bacteria | Tritrichomonas foetus, Trichomonas gallinae |
| Food-species regulatory status | Prohibited in EU Table 2 of Regulation (EU) No 37/2010; US extralabel prohibition under 21 CFR 530.41 | Prohibited extralabel in food animals in US; not authorised in EU food species | Not authorised for food-producing species; extralabel restriction may apply |
Clinical interchange among nitroimidazoles cannot be based on equivalent milligram dosing. Dimetridazole has historically been associated with histomoniasis and avian trichomoniasis, while metronidazole is used for giardiasis and anaerobic bacterial infections in companion animals. Ronidazole is used in feline tritrichomoniasis, but its narrow safety margin in cats requires accurate compounding and avoidance of extended-release formulations. Published data for direct comparative efficacy is limited, and treatment selection should follow approved labelling or national prescribing policy for the target species.
Process transfer and storage boundaries derive from the nitroimidazole redox chemistry. Dimetridazole is incompatible with strong reducing agents, which can convert the nitro group to reactive intermediates, and with strongly alkaline media above pH 8.0, where crystalline degradation can occur at elevated temperature. Bulk powder should be stored in sealed, light-resistant containers at controlled room temperature; repeated opening of non-barrier bags at relative humidity above 60% may increase moisture uptake and reduce flow. Milling and micronisation should incorporate dust collection, because airborne nitroimidazole dust presents an occupational exposure hazard and cross-contamination risk in multiproduct facilities. Cleaning validation should use HPLC with a limit of detection below 0.1 ppm for equipment rinse samples when the next product is a non-nitroimidazole animal drug. These boundaries determine the suitability of the API for conventional tablet, capsule, injection, powder, granule, premix, and solution processes.
