| HS Code | 929018 |
| Productname | Dinolitimide Premix Veterinary Grade API |
| Chemicalname | 2-Methyl-3,5-dinitrobenzamide |
| Casnumber | 148-01-6 |
| Molecularformula | C8H7N3O5 |
| Molecularweight | 225.16 g/mol |
| Appearance | Yellow crystalline powder |
| Assay | 98.0% - 101.0% on dried basis |
| Meltingpoint | 181°C - 183°C |
| Solubility | Sparingly soluble in water; soluble in ethanol, acetone, and dimethylformamide |
| Lossondrying | ≤ 0.5% |
| Residueonignition | ≤ 0.1% |
| Heavymetals | ≤ 10 ppm |
| Storageconditions | Store in a cool, dry place, protected from light and moisture |
| Shelflife | 24 months from date of manufacture |
| Grade | Veterinary grade API for non-sterile formulations |
| Targetspecies | Poultry, swine, and rabbits |
| Therapeuticuse | Antiprotozoal and anticoccidial agent |
| Dosageforms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
As an accredited Dinolitimide Premix 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 | Sealed double polyethylene-lined fiber drums with tamper-evident closures to protect stability and purity. Quantity: 25 kg per drum. |
| Container Loading (20′ FCL) | 20′ FCL container loaded with Dinolitimide Premix Veterinary Grade API, safely secured, temperature-controlled, moisture-protected, ready for global pharmaceutical transport. |
| Shipping | Shipped in sealed, moisture-resistant, tamper-evident containers, protected from light and extremes of temperature. Labeled strictly for veterinary use only. Transported via validated carriers with full documentation, including Certificate of Analysis and safety data sheet. Must be kept away from food, feedstuffs, and unauthorized personnel during transit. |
| Storage | Store in a cool, dry, well-ventilated area, protected from direct sunlight, heat, and moisture. Keep the container tightly closed when not in use. Avoid storage above 25°C and do not freeze. Keep away from food, feed, and incompatible substances. Ensure proper labeling and restrict access to unauthorised personnel. Use within the stated shelf life. |
| Shelf Life | Shelf life is typically 24 months when stored sealed, dry, and protected from light at controlled room temperature. |
In broiler integrator feed mills, the supplied Dinolitimide Premix Veterinary Grade API is handled as dinitolmide (zoalene), a synthetic nitrobenzamide-class coccidiostat used in oral feed applications. Across the reviewed regulatory and feed-compounding literature, the compound is not supported as an injectable, tablet, capsule, or true aqueous solution dosage form; blendable powders, granules, and medicated premixes are the technically coherent downstream presentations. In U.S. broiler operations, the target complete-feed concentration is 125 mg/kg (0.0125 wt%) under 21 CFR 558.680, with medicated feed CGMP enforced through 21 CFR 225 and site HACCP structured under ISO 22000:2018. When the product is supplied as a 5% w/w premix, the feed mill addition is 2.5 kg/t; a 10% w/w premix requires 1.25 kg/t, and direct addition of the active substance at 100% potency requires 125 g/t. The production path begins with pre-blending the premix or API with a carrier such as ground corn cob, rice hulls, or calcium carbonate in a ribbon blender at 60–70% fill for 5–8 min, followed by transfer into the main batch mixer. Mixer performance for dinitolmide is not assumed; blend uniformity is verified by HPLC on a minimum of 10 sampling points per batch, and the coefficient of variation must remain at or below 5%. If CV exceeds 5%, the carrier particle size, mixer fill, or mixing time is adjusted before release. From the main mixer, the mash moves to steam conditioning at 70–85°C; die compression ratios between 1:8 and 1:12 are typical on pellet mills servicing broiler lines, and pellet physical quality is measured under ASAE S269.5. Because published stability data for dinitolmide across high-shear, extended-residence pelleting configurations is limited, the mill must validate chemical recovery by HPLC in the first 3 production batches and after any conditioner change above 85°C or residence time beyond 120 seconds. Post-pelleting recovery is handled in the cooler and crumble rolls; after a medicated lot, the unmedicated withdrawal feed may not be run until a validated flush of ground corn or soybean meal has passed through the mixer, elevator, pellet die, and cooler, and carryover has been analytically confirmed below the destination-market detection limit. Terminal finished forms leaving this application are broiler starter crumble, broiler grower pellet, broiler finisher pellet, and farm-delivery mash for non-pelleted feeding systems.
| Production class | Complete-feed target | 5% w/w premix inclusion | 10% w/w premix inclusion | Mixer CV limit |
| Broiler chickens | 125 mg/kg | 2.5 kg/t | 1.25 kg/t | ≤5% |
| Turkeys | 150 mg/kg | 3.0 kg/t | 1.5 kg/t | ≤5% |
| Replacement pullets | 125 mg/kg | 2.5 kg/t | 1.25 kg/t | ≤5% |
Replacement pullet rearer feeds create a process conflict that is not present in routine broiler coccidiosis prevention. Live Eimeria oocyst vaccines depend on early oocyst shedding and recirculation in litter; dinitolmide suppresses coccidial development and therefore reduces vaccine cycling if the two are administered concurrently. The compliance boundary in this application is stricter than the feed concentration arithmetic. The pullet developer feed must comply with the species and production-class restrictions of the registered dinitolmide label in the country of use, including the prohibition against feeding laying hens and the required withdrawal interval before birds enter the production laying house. Under 21 CFR 558.680, laying-hen feed use is not authorized, and medicated feed production remains subject to 21 CFR 225 CGMP requirements. The quantitative target where approval exists for replacement pullets is 125 mg/kg complete feed, equivalent to 2.5 kg/t of a 5% w/w premix; this concentration is not transferred to birds in egg production. The production sequencing is reversed relative to broiler medicated programmes: newly vaccinated pullets consume an unmedicated starter feed to establish vaccine oocyst cycling; only after the vaccine programme’s no-medication window has closed is the dinitolmide-medicated rearer feed introduced. Feed bins, augers, and hoppers that handled the medicated rearer ration must be flushed before a subsequent unmedicated transition feed is manufactured, because dinitolmide carryover into the vaccine phase or into the pre-lay transition compromises both immunity and residue control. Finished products from this application are pullet starter crumble, unmedicated vaccine-phase feed, dinitolmide-medicated rearer mash or pellet, and a final unmedicated transfer feed placed before housing in lay facilities.
Turkey floor-rearing systems differ from broiler lines in one quantitative respect: the U.S.-codified dinitolmide concentration in complete feed is 150 mg/kg (0.015 wt%) under 21 CFR 558.680. The corresponding addition of a 5% w/w premix is 3.0 kg/t, and a 10% w/w premix is cut at 1.5 kg/t. Downstream milling resembles broiler feeds in equipment terms—mash conditioning, pelleting, cooling, and crumbling—but the target dose is 20% higher, and turkey poults in the first week consume only a few grams of feed daily. This low early feed intake makes dinitolmide distribution errors in the mixer physically more consequential; blend uniformity measured at 10 sampling points must still meet a ≤5% CV limit, and a starter batch with overlubricated pellet surfaces or carrier agglomerates can depress intake and underdose young birds. Compliance for turkey rations must be verified against the market-specific withdrawal period and bird-age restrictions because tissue residue kinetics in turkeys are not assumed to be identical to broilers; the exporting mill must not ship dinitolmide-medicated turkey feed into a market with a non-harmonised residue monograph. Terminal finished forms leaving this application are turkey starter crumble and turkey grower pellet, with subsequent unmedicated feeds produced only after a validated line flush. Published data for dinitolmide in certain extended grow-out turkey programmes beyond the registered age class is limited; the feed mill must confirm label authorization before assigning the product to late grower or finisher rations.
Contract premix plants receiving Dinolitimide Premix Veterinary Grade API perform a different unit operation from feed mills; the objective is not a complete feed at 125 mg/kg or 150 mg/kg, but a label-guaranteed premix that downstream mills can dose at the correct kilograms per tonne. The applicable standards matrix for this activity includes FAMI-QS, ISO 22000:2018, and U.S. 21 CFR 225 for medicated feed premises where applicable; export premix registration must be maintained for each destination market. The formulation addition ratio at the premix plant is defined by the label guarantee: a 5% w/w dinitolmide premix contains 50 g/kg active substance, and the downstream dose is 2.5 kg/t for chickens or 3.0 kg/t for turkeys. To avoid segregation and overdose hotspots, the API is diluted by stepwise geometric dilution at a step ratio not exceeding 1:10 into a carrier such as calcium carbonate, ground corn cob, or rice hulls; a double-ribbon or ploughshare mixer at 60–70% fill is used, and the mix is sampled at 10 points to verify a ≤5% CV. After every dinitolmide-containing batch, contract manufacturers must run a verified cleanout or flush batch, because residual dinitolmide in the next non-medicated premix is a chemical cross-contamination hazard under HACCP. Carryover is confirmed by HPLC assay of the subsequent batch rather than by visual inspection; visual absence of colour is not acceptable as a cleaning record. Terminal products leaving the premix plant are 25 kg bags with polyethylene liners, bulk totes, or supersacks of 1%, 2.5%, 5%, or 10% w/w dinitolmide premix, plus custom blends for licensed feed mills. Fixed-dose combinations with other coccidiostats or growth-modulating additives are not assumed to be authorized; each combination must be supported by the destination-market registration and stability data.
| Reference | Scope | Dinitolmide-specific condition |
| 21 CFR 558.680 | Coccidiostat dosage in medicated feed | 125 mg/kg chickens; 150 mg/kg turkeys; do not feed to laying hens |
| 21 CFR 225 | CGMP for medicated feed manufacturing | batching records, flush sequence, equipment cleanout documentation |
| FAMI-QS | Feed additives and premixtures quality system | premix label guarantee, carryover verification, complaint handling |
| ISO 22000:2018 | Food safety management system | HACCP plan must classify dinitolmide cross-contamination as a chemical hazard |
| ASAE S269.5 | Pellet durability index | physical pellet quality; does not replace chemical assay of dinitolmide recovery |
On-farm or small-mill mixing of dinitolmide powder/granule is a lower-energy process than commercial pelleting and is requested where pelleted feed is unavailable, where a small flock cannot justify commercial batch sizes, or where a veterinary directive specifies in-farm preparation. The regulatory boundary is the narrowest of all scenarios because on-farm use must remain within the registered label of the dinitolmide product in the country of use; do not feed to laying hens, observe the label withdrawal interval before slaughter, and do not use the product in minor poultry species unless the national registration explicitly includes the species. Published data for dinitolmide efficacy in game birds and other minor species under current field conditions is limited. The theoretical direct addition is 125 mg/kg (125 g/t) for chickens; however manual weighing of 125 g into 1000 kg of feed is a recognised scale-error and homogeneity failure point. The preferred farm addition is therefore 2.5 kg/t of a 5% w/w premix, or 25 kg/t of a 0.5% w/w premix. Granule carriers with particle size distribution matched to the feed matrix reduce segregation more effectively than fine API powder; the farm mixing operation should use a horizontal batch mixer at 60–70% fill and a staged geometric dilution into corn meal or wheat bran at 1:10 steps. After mixing, the farm must verify dinitolmide concentration by laboratory HPLC on at least 10 points per batch, with a ≤5% CV target; if this is not feasible on site, the mix should not be released without a written sampling and assay plan. Top-dressing a few grams of powder onto finished pellets without batch mixing is not a validated application and creates high risk of underdose, overdosed birds, and residue-control failure. Terminal finished forms generated through this channel are farm-mixed mash, non-pelleted meal, or mixed rations for broiler and pullet flocks; aqueous drinking water solutions and injectable presentations are not recognised for this molecule in the reviewed authorisations because the water solubility of dinitolmide is insufficient for a true solution at therapeutic concentration.
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Dinolitimide Premix Veterinary Grade API is the manufacturer-designated active pharmaceutical ingredient of dinitolmide, a synthetic nitrobenzamide coccidiostat. The molecular formula is C8H7N3O5, CAS 148-01-6, molar mass 225.16 g/mol. The substance appears in older literature as zoalene and 3,5-dinitro-o-toluamide. The grade is supplied as a crystalline powder for downstream processing into tablets, capsules, powders, granules, premixes, and oral solutions. No public pharmacopoeia assigns a product code; the model designation on the certificate of analysis is manufacturer-specific. Purchase specifications must therefore fix the exact grade code to prevent substitution with feed-additive material that has larger particle size or unqualified residual-solvent control.
Manufacturing is conducted under active pharmaceutical ingredient GMP aligned with ICH Q7 and EudraLex Volume 4 Part II. Release documentation should include identity, assay, related substances, loss on drying, sulphated ash, particle-size distribution, and residual solvents. The standard premix grade is not automatically suitable for aseptic injection processing. Bacterial endotoxin and sterility controls are not present on a feed premix release certificate unless explicitly requested and priced as a parenteral-process-grade active. The product is intended solely for veterinary use and should not be released for human pharmaceutical manufacture.
For medicated-feed production, the mixing behaviour of dinitolmide is controlled by particle size and the active-particle number per gram of premix. Fine milling increases dusting and electrostatic adhesion on vertical mixer walls; oversize crystals segregate during transfer and threaten content uniformity. The release particle-size envelope is therefore fixed between the API manufacturer and the feed-mill operator. Laser diffraction complies with ISO 13320, while sieve analysis follows Ph. Eur. 2.9.38. D10, D50, and D90 values are reported on the certificate of analysis, because no harmonised pharmacopoeial limit applies across all dosage forms.
| Parameter | Reference method | Release expectation |
|---|---|---|
| Identity | Infrared absorption, Ph. Eur. 2.2.24 | Matches reference spectrum |
| Assay | HPLC, in-house validated | 98.0–102.0% on dried basis |
| Loss on drying | Ph. Eur. 2.2.32 | ≤0.5% |
| Sulphated ash | Ph. Eur. 2.4.14 | ≤0.1% |
| Particle-size distribution | Laser diffraction, ISO 13320 | D10, D50, D90 reported on CoA |
| Residual solvents | ICH Q3C / VICH GL18 | Class limits based on synthesis |
The limit values shown in the table are the default release expectations for a dry veterinary API; the marketing authorisation may tighten or replace them with a manufacturer-specific specification. In a GMP audit, the receiving site should verify that the API manufacturer has validated the HPLC method for specificity, linearity, and accuracy. Audit checkpoints should include change-control records for milling, because a casual change from pin-milling to jet-milling can alter flow and segregation even when the chemical assay remains identical.
For dry oral solid dosage forms, the API is screened through a 0.5 mm sieve before blending in a tumble mixer or high-shear granulator. Direct compression is feasible only when the powder exhibits acceptable flow through gravity-fed tableting tooling; if the flow is insufficient, a wet granulation step is introduced after confirming that the compound remains stable under aqueous binder addition. For capsule filling, dosator or tamping-pin systems are used, and static charge is controlled by maintaining the filling suite within the humidity range defined in the batch record. In feed-mill premix lines, the low inclusion rate demands geometric dilution before final feed mixing; a two-stage mix in a horizontal ribbon blender is used with a validated mixing time and sampling plan.
Tablets containing dinitolmide are tested for content uniformity by liquid chromatography and are required to comply with Ph. Eur. 2.9.40. Friability is measured according to Ph. Eur. 2.9.7; disintegration is tested at 37°C in purified water. Because the active is practically insoluble, tablet dissolution is not a pharmacopoeial sink-condition method and is normally replaced by assay and related-substances data. The batch record must state the compression force, tablet hardness range, and sieve-cut granulation, because the finished-product specification cannot be transferred directly from a feed premix monograph.
Dinitolmide has very low aqueous solubility and lacks a readily ionisable acid or base centre suitable for simple pH-dependent salt formation. A plain aqueous injection is therefore not controlled by a public parenteral monograph. If an injectable presentation is required, the formulator must develop an oil-based, co-solvent, or nanosuspension carrier; the API must then be tested for bacterial endotoxin by Ph. Eur. 2.6.14 and for sterility by Ph. Eur. 2.6.1. The standard feed-premix grade is not manufactured under aseptic conditions and does not include those controls. Published data for injectable dinitolmide formulations are limited, so the registration applicant must generate product-specific tissue and residue data rather than assume that the premix active can be repurposed by simple dissolution.
Oral solutions are more practical than injections, but they are typically suspensions. High-shear dispersion is used to wet the particles; viscosity, sedimentation volume, and redispersability are controlled in the finished solution. Particle-size reduction is performed before wetting to avoid agglomeration. The API particle-size distribution remains the critical variable, and the solution manufacturer should use the same laser-diffraction release data required for premix production.
The difference from ionophore anticoccidials is chemical rather than physical. Monensin sodium, salinomycin, and narasin are polyether ionophores; dinitolmide is a nitrobenzamide and is not classed with ionophores. The practical consequence on a manufacturing site is that dinitolmide does not contribute the same non-target species hazard profile as ionophore-antibiotic carryover; nevertheless, separate production lines or validated cleaning are required under Regulation (EU) 2019/4 to prevent contamination of non-medicated feed. Direct comparison with triazine-based anticoccidials such as toltrazuril is not a simple substitution: dinitolmide is a feed-use prophylactic agent, whereas triazine preparations are often positioned for treatment during active intestinal coccidial stages. The raw API grade therefore should be chosen only after the target Eimeria species and the production stage are defined in the veterinary prescribing cascade.
Compared with nicarbazin, which is a molecular complex, dinitolmide does not require the same stoichiometric pairing during synthesis. This gives a simpler impurity profile but also gives different withdrawal-period and residue-monitoring obligations. In regulatory submissions, the applicant must demonstrate that the analytical method separates dinitolmide from nitrobenzamide-related impurities; no public monograph assigns a single impurity threshold across all jurisdictions. Method transfer between the API manufacturer and the dosage-form manufacturer is required for assay, related substances, and residual solvents.
Veterinary registration files for premix and oral solid forms are supported by forced-degradation studies under VICH GL3. The API is exposed to heat, humidity, light, and oxidative conditions, followed by liquid chromatography to identify degradation products. Dry powder dinitolmide shows limited degradation at typical warehouse conditions, but the specific profile in a blended premix cannot be predicted without product-specific data. A stability study on the formulation at 25°C / 60% RH and 40°C / 75% RH is used to set retest and shelf-life parameters. Published data for the Dinolitimide-branded premix grade are limited to the manufacturer’s registration file; batch-specific CoA data should not be used as a substitute for a formal stability commitment.
Residual solvent clearance is handled under ICH Q3C, with VICH GL18 as the veterinary guideline where applicable. If the synthesis uses toluene or ethanol, the certificate of analysis must list class and residual levels. The powder is not hygroscopic enough to require drying before use in most dry applications, but when ambient relative humidity exceeds 60%, the manufacturer should evaluate moisture uptake during transfer and may require a re-dry step only if the loss-on-drying limit is exceeded. This boundary prevents moisture-induced flow defects on high-speed tablet presses.
Feed-additive-grade dinitolmide is produced for direct inclusion in feed and may have a wider particle-size specification and less rigorous residual-solvent control than the premix veterinary API grade. The API grade described here is released against an active pharmaceutical ingredient monograph, with HPLC assay and related-substances data. The excipient compatibility and tablet properties require the API particle-size distribution to be narrowly controlled; a feed-grade lot may contain agglomerates that survive mixing and create assay non-uniformity. The difference is therefore not a different molecule, but a different quality-management envelope and physical specification. Buyers should compare certificates of analysis at the level of D50/D90, residual solvents, and microbial quality rather than by the common chemical name alone.
For powder and granule presentations, blend uniformity is confirmed by sampling at 10 or more points across a ribbon blender. If the relative standard deviation of the active content exceeds the marketing-authorisation limit, mixing time is extended or baffle speed is reduced. Particle-size oversize is the most common cause of blend failure, not chemical instability. The API manufacturer therefore supplies a particle-size certificate with each lot, and the recipient should re-test after any pin-milling or de-agglomeration step. These controls are not captured in a simple purity assay; they require a coherent powder characterisation package that distinguishes the veterinary API from lower-cost feed-grade forms.
