| HS Code | 689530 |
| Product | Nicarbazin Premix Veterinary Grade API |
| Chemicalname | 4,4'-Dinitrocarbanilide compound with 4,6-dimethyl-2-pyrimidinol (1:1) |
| Casnumber | 330-95-0 |
| Molecularformula | C19H18N6O6 |
| Molecularweight | 426.38 g/mol |
| Appearance | Yellowish crystalline powder |
| Meltingpoint | 265°C - 275°C (decomposition) |
| Solubility | Practically insoluble in water and ethanol; soluble in dimethylformamide and concentrated sulfuric acid |
| Assay | 97.0% - 103.0% on dried basis |
| Storage | Protect from light and moisture; store in a cool, dry, well-ventilated place |
| Dosageformcompatibility | Tablets, injections, capsules, powders, granules, premix, solutions |
As an accredited Nicarbazin 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 | Packaged in 25 kg multilayer laminated bags or fiber drums with sealed inner liners, ensuring stability and safety for veterinary use. |
| Container Loading (20′ FCL) | One 20′ FCL of Nicarbazin Premix Veterinary Grade API, suitable for tablets, injections, capsules, powders, granules, premixes, and solutions. |
| Shipping | Nicarbazin Premix Veterinary Grade API is shipped in sealed, moisture-resistant containers to preserve potency and stability. Transport complies with international hazardous material regulations, with clear labeling and documentation. Shipments are temperature-controlled to prevent degradation, and handling precautions protect against inhalation or skin contact, ensuring safe delivery for downstream pharmaceutical manufacturing. |
| Storage | Store Nicarbazin Premix Veterinary Grade API in a cool, dry, well-ventilated area, away from direct sunlight, moisture, heat, and incompatible materials. Keep containers tightly sealed when not in use. Avoid generating dust; use appropriate personal protective equipment. Ensure storage complies with local regulations and is inaccessible to children and unauthorized personnel. |
| Shelf Life | Shelf life: 24 months when stored in original sealed container, protected from moisture, heat, and light. |
A low-dose nicarbazin premix is not a simple dilution; it is a dry micro-ingredient system in which the active complex must remain homogeneously distributed down to the final broiler feed concentration of 27.2–45.4 g/ton authorized under 21 CFR 558.366. The equimolar complex of 4,4'-dinitrocarbanilide and 2-hydroxy-4,6-dimethylpyrimidine is typically applied as a 0.5–5.0% w/w intermediate on calcium carbonate, rice hull or precipitated silica carriers. Because the final feed dose is in the low-ppm range, the practical segregation boundary is not the assay mean but the coefficient of variation across 10–20 consecutive samples withdrawn from a working mixer and from bagging off-take points; concentrate CV values above 5% routinely translate into final feed CV values above 10% after transfer through bucket elevators and drag conveyors. Compliance documentation for this sector is anchored to 21 CFR 558.366 for the US market and to the EU feed-additive authorization under Regulation (EC) No 1831/2003 where the premix is registered as a coccidiostat. Finished premix assay is performed by HPLC against the current USP Nicarbazin monograph, with the DNC:HDP molar ratio controlled at 1:1 and water content determined by Karl Fischer titration, generally held below 5 wt% to limit microbial growth and particle agglomeration.
| Premix concentration (w/w) | Addition rate (kg/tonne complete feed) | Nicarbazin delivered (g/tonne) | Target mixer CV |
|---|---|---|---|
| 0.5% | 8.0 | 40 | ≤5% |
| 1.0% | 4.0 | 40 | ≤5% |
| 2.5% | 1.6 | 40 | ≤5% |
| 5.0% | 0.8 | 40 | ≤5% |
The production line for this powder form typically uses a ribbon blender or ploughshare mixer with a working volume of 500–2,000 L, fitted with an intensifier bar for deagglomeration. The API is first passed through a 60-mesh screen or pin mill to break crystalline aggregates; the measured D90 is then held within the specification established during process qualification because batch-to-batch shifts in particle size above 75 µm can elevate the angle of repose and concentrate active in fines. The sequence of addition is half the carrier, the screened nicarbazin, the remaining carrier, and finally 0.5–1.5 wt% mineral oil as a dust suppressant, mixed for 10–15 minutes until the discharge coefficient of variation is ≤5%. The resulting product is a medicated powder premix intended solely for incorporation into broiler starter, grower or finisher meal at the registered feed mill.
Granulated nicarbazin premix is specified where pneumatic conveying and micro-dosing equipment generate electrostatic fines, bridge formation or uneven delivery at feed mills operating under high relative humidity. The granulation pathway converts the same 0.5–5.0% w/w active concentration into a free-flowing dense granule with a target size fraction retained between 20-mesh and 80-mesh screens, which reduces the airborne dust fraction during bin filling and helps maintain dose uniformity when the premix is metered at rates below 1 kg/tonne. Formulation-level binders for this application are selected from low-residue carbohydrate or lignosulfonate systems, applied as an aqueous solution at 2–5 wt% of dry mix in a high-shear mixer-granulator; the wet mass is then discharged through a conical sieve before drying in a fluid bed at an inlet temperature not exceeding 60°C to avoid binder crust formation and retain granule porosity. Equipment qualification includes measurement of granule friability, Hausner ratio, and loss on drying after 20 minutes at 105°C. Industry compliance for this form remains identical to the powder form: the final feed concentration in US broiler production is 27.2–45.4 g/ton under 21 CFR 558.366, and the premix itself must not be fed directly to animals. The downstream production unit receiving the granulated premix is normally a feed mill micro-batching station with load-cell accuracy of ±0.1%; each batch record links the premix lot number, scale increment and final feed HPLC assay result to demonstrate traceability under Regulation (EC) No 183/2005 feed hygiene requirements. The terminal product is a low-dust granule used in the manufacture of medicated broiler feed, not a final feed or a water-administered product.
Steam conditioning in a broiler feed mill exposes the nicarbazin molecule to temperatures that are low relative to its decomposition point of approximately 260–265°C, but the operative risk is not thermal destruction; it is analytical recovery in pelleted and crumbled feed that is affected by segregation, abrasion, and feed sample preparation. When a 1% nicarbazin premix is metered into a 2-tonne main mixer at 4.0 kg/tonne, the target final feed activity of 40 g/ton must be verified after conditioning at 80–85°C for 30–60 seconds and extrusion through a die with a compression ratio of 8:1 to 10:1. Published data for this specific configuration is limited, so feed mills typically establish in-house recovery limits of 95–110% of label claim based on HPLC determination of the DNC moiety in pelleted samples. The downstream production sequence is regulated as a medicated feed operation under 21 CFR 558.366 and must follow the sequence: micro-batch the nicarbazin premix, blend with ground corn and soybean meal for 3–5 minutes, condition with steam, pellet at 75–85°C, cool to within 5°C of ambient, and then add post-pellet fat or enzyme liquids. Feed mills running this sequence must not use nicarbazin in laying-hen rations; label withdrawal is 5 days before slaughter, and batch flushing with a non-medicated feed is required before a non-target species line starts. The terminal product types are pelleted broiler grower feed and crumbled broiler starter feed, both carrying the same final feed concentration range and the same label restrictions.
In ionophore rotation and shuttle programs, nicarbazin is co-formulated with narasin to widen the spectrum against Eimeria tenella, E. acervulina, E. maxima and E. necatrix while reducing the selection pressure generated by continuous single-ionophore use. The approved US combination is not a simple co-blend of two independent premises; it must be manufactured and labelled under the fixed-ratio authorization in 21 CFR Part 558, with final feed activity commonly ranging from 27.2 g/ton to 45.4 g/ton for each active. The nicarbazin component and narasin operate through different anticoccidial mechanisms, and the combination is therefore not interchangeable with a nicarbazin-only premix at equal total dose. Downstream mixing is performed at the feed mill using either a dual-metering or sequential addition sequence: the narasin premix is first dispersed into the main mixer for 2 minutes, the nicarbazin premix is added, and mixing continues for another 4–6 minutes before the batch is discharged. Mortar and pestle calibration checks at the micro-batching station are required because narasin is not approved for turkeys or guinea fowl, and carryover into a non-target species line can produce toxic signs. Turkeys, guinea fowl and laying hens must be excluded from any line that runs this combination, and the label withdrawal period for broilers is 5 days before slaughter.
| Final nicarbazin (g/ton) | Final narasin (g/ton) | Regulatory/use boundary |
|---|---|---|
| 27.2 | 27.2 | Broiler starter or grower; withdrawal 5 days |
| 36.3 | 36.3 | Broiler shuttle program; not for laying hens |
| 45.4 | 45.4 | Finisher; non-target species exclusion required |
Terminal products are broiler starter, grower and finisher feeds labelled for coccidiosis prevention; the same combination may not be used in replacement pullets or breeders. Published stability studies for this specific combination premix are limited, so the responsible formulator verifies both actives by HPLC after a 60-day warehouse storage at 25°C and 60% RH to confirm physical stability and active assay.
A separate non-food pathway for nicarbazin is the fertility-control bait for feral pigeon flocks and some managed waterfowl populations. In this application, the active complex is not used as a coccidiostat and is not delivered through feed-mill equipment; it is formulated into a grain-based kibble or pellet under a label that defines the daily intake per bird and the flock-size-based feeder deployment. The typical ready-to-use bait contains nicarbazin at a nominal 0.5% w/w, and the daily ration is metered through gravity or timer-controlled feeders using the registered label's flock-size table; the label-specified grams-per-bird-day figure is not a single universal constant because feral pigeon body weight and foraging pressure vary among sites. Because this use is outside the US FDA feed-additive framework, the product is registered as an avian reproductive inhibitor under the applicable FIFRA label in the United States; jurisdictions outside the US require separate national registration. The label restrictions exclude food-producing birds and require removal of uneaten bait before periods when non-target species are present.
The production process for this bait form relies on dispersion of micronized nicarbazin into a cooked grain matrix at temperatures below 70°C to maintain particle adhesion and avoid separation of the low-dose active from the larger pellet fraction. Batch records must document active assay after pellet cooling, because the move from powder API to kibble creates the same low-dose homogeneity problem seen in feed but with a harder, larger terminal matrix; a 60-mesh or finer API input is generally required, and the finished bait is screened to remove fines that would concentrate nicarbazin in the bottom of feeder hoppers. The terminal product is a ready-to-use bait pellet for municipal and agricultural avian management programs; it is not a premix, not a tablet, and not an injectable or aqueous solution formulation. Published data for this specific configuration is limited, so each production lot is assayed by HPLC before release and the day-to-day feeding rate is adjusted from the observed flock census rather than from a fixed volumetric setting.
Competitive Nicarbazin Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Nicarbazin Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a synthetic anticoccidial complex of 4,4'-dinitrocarbanilide and 2-hydroxy-4,6-dimethylpyrimidine. The two components have molecular weights of 302.24 g/mol and 124.14 g/mol; the equimolar complex has a combined molecular weight of 426.38 g/mol and CAS 330-95-0. The unformulated active pharmaceutical ingredient is a yellow to pale-yellow crystalline powder that is practically insoluble in water under Ph. Eur. 5.11 solubility criteria and soluble in polar aprotic solvents such as dimethylformamide. Supply documentation typically distinguishes two grades: a 25% w/w feed premix on a cereal/calcium carbonate carrier and a ≥98% w/w API grade for subsequent tablet compression, capsule filling, granulation, powder blending, or suspension compounding. In broiler chickens, the primary use is prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. necatrix, and E. brunetti. U.S. authorization under 21 CFR 558.366 allows 0.01–0.02% nicarbazin in complete feed, corresponding to 100–200 mg/kg, with a 5-day preslaughter withdrawal. The product is not indicated for laying hens or breeder replacements; DNC transfer into eggs has been associated with yolk mottling, reduced hatchability, and shell depigmentation.
Release testing for the 98% API grade is performed by high-performance liquid chromatography with ultraviolet detection at 265 nm under Ph. Eur. 2.2.29. Assay acceptance is 98.0–102.0% on the dried basis. Loss on drying is not more than 1.0% by Ph. Eur. 2.2.32. Residue on ignition is not more than 0.1% by USP 281. Heavy metals as lead are controlled at not more than 20 ppm by Ph. Eur. 2.4.8. For the 25% premix, assay is expressed against label claim and typically set at 95.0–105.0%, with higher moisture allowance because of the vegetable carrier and a sieve requirement linked to final-feed homogeneity.
| Test parameter | 98% API grade | 25% w/w premix | Test method |
|---|---|---|---|
| Appearance | yellow to pale-yellow crystalline powder | yellow free-flowing powder on cereal/calcium carbonate carrier | visual |
| Assay | 98.0–102.0% dried basis | 95.0–105.0% of label claim | HPLC-UV at 265 nm, Ph. Eur. 2.2.29 |
| Loss on drying | ≤1.0% | ≤10.0% | Ph. Eur. 2.2.32 |
| Residue on ignition | ≤0.1% | not applicable | USP 281 |
| Heavy metals as lead | ≤20 ppm | ≤20 ppm | Ph. Eur. 2.4.8 |
| Particle size | D90 ≤250 µm | ≥90% through 60 mesh | Ph. Eur. 2.9.38 |
Residual solvents in the 98% API grade are controlled by headspace gas chromatography under Ph. Eur. 2.4.24, with limits assigned according to ICH Q3C for Class 2 and Class 3 solvents such as methanol, dimethylformamide, or acetone. Veterinary API manufacture is expected to follow ICH Q7 GMP; each lot must be accompanied by a certificate of analysis, and the manufacturer may be required to declare the residual solvent profile, heavy metals, and related substances to finished-product applicants. Published data for specific carrier composition of the 25% premix is limited; the certificate of analysis should therefore be treated as the controlling specification when calculating final feed inclusion or when designing a granulated or encapsulated intermediate.
Production-scale incorporation of the 25% premix into broiler feed is validated by collecting 10 samples from a ribbon or twin-shaft paddle mixer after dry and post-liquid addition phases. Samples are assayed for DNC by HPLC; a coefficient of variation below 5% is the usual in-plant release criterion. Failures above 5% CV are most frequently traced to electrostatic fines on the 98% API, bridging of the 25% premix in the micro-ingredient hopper, or inadequate cleanout of screw conveyors. Twin-shaft paddle mixers of 2–3 tonne capacity generally require 4–6 minutes dry mixing after premix addition and 2–3 minutes post-liquid mixing when edible oil is sprayed at 1–2% w/w for dust control. The addition sequence should place nicarbazin premix before soybean meal and limestone; this prevents active particles from preferentially adhering to high-lipid raw materials and causing low sidewall assay results. Segregation risk increases when the particle-size difference between premix and feed base exceeds 100 µm, and post-mix conveying should use mass-flow hoppers or short horizontal transfer rather than long pneumatic lines. Batch-to-batch variance is commonly introduced by carrier lot changes. Ground corn cob fractions with moisture above 12% or excessive fines below 250 µm alter the angle of repose and cause irregular flow from the micro-ingredient hopper. When carrier bulk density shifts by more than 0.05 g/cm³, the mixer fill volume and liquid addition rate should be revalidated.
Non-feed dosage forms derived from the 98% API grade are constrained by solubility and flow properties. Direct compression of the unmodified API is not normally feasible; dry granulation or slugging on a rotary tablet press is required before final compression with microcrystalline cellulose and croscarmellose sodium. Wet granulation may be performed with povidone K30 at 2–5% w/w and purified water, but the HDP component is weakly basic and the DNC component wets slowly; preheating the binder solution to 40–50°C improves mass uniformity. The finished granules should be dried to a loss on drying below 2% before compression to prevent sticking on tablet punches. Injectable solutions are not a recognized target-species route for nicarbazin. The compound is practically insoluble in water; a true parenteral solution would require non-aqueous vehicles such as dimethylacetamide or N-methyl-2-pyrrolidone, for which published safety data in poultry are limited. Oral suspensions prepared from the 25% premix require continuous agitation because DNC particles settle within minutes without a suspending agent. These technical boundaries explain why the premix and powder presentations dominate regulated use, while the tablets/injections/capsules designation refers to compounding-grade availability rather than demonstrated bioequivalence in each route.
Nicarbazin is not a polyether ionophore. The DNC–HDP complex is associated with mitochondrial electron-transport inhibition in apicomplexan parasites, whereas monensin, salinomycin, and narasin disrupt cation gradients across the parasite membrane. This mechanistic difference supports the use of nicarbazin in rotation or shuttle programs where field Eimeria isolates show reduced ionophore sensitivity, although published susceptibility data for specific isolates is limited and should be verified by floor-pen challenge. The dose differential is substantial: nicarbazin is typically incorporated at 125 mg/kg complete feed, while monensin in broiler feed is used at 90–110 mg/kg and salinomycin at 40–60 mg/kg. Unlike diclazuril, a benzeneacetonitrile coccidiostat used at 1 mg/kg or less, nicarbazin requires a higher mass intake; consequently, carrier homogeneity and analytical recovery in final feed have a larger influence on clinical efficacy. Amprolium differs further as a thiamine antagonist with primary activity against first-generation schizonts, while nicarbazin is active against both asexual and sexual stages of major Eimeria species. An important operational boundary is heat stress. Nicarbazin impairs thermoregulation in broilers, and field reports show increased mortality when house temperatures exceed 30°C; many integrators restrict its use to cooler months or to houses with evaporative tunnel ventilation. The product is contraindicated in laying hens and breeder replacements because of egg residues and reproductive effects, which are not observed with several ionophore programs at approved doses.
The marker residue for nicarbazin is DNC. Regulatory laboratories measure DNC in poultry muscle, liver, skin/fat, and eggs by liquid chromatography-tandem mass spectrometry using confirmatory ion ratios under Commission Decision 2002/657/EC validation criteria. Because DNC is lipophilic, depletion from skin/fat and egg yolk is slower than plasma clearance; the U.S. 5-day withdrawal period in 21 CFR 558.366 applies to broiler feed at authorized concentrations and cannot be extrapolated to other species, higher doses, or unapproved formulations. Feed mills must implement flush batches or sequencing after medicated feed to prevent carryover into withdrawal feeds; carryover above 1% of the previous batch is a common source of violative tissue residues in slaughter plants. Maximum residue limits for DNC in target tissues are established in multiple jurisdictions, but published values differ by market; exporters must verify current MRLs before arranging slaughter. The analytical method decision limit and detection capability should be determined during validation and must remain below the relevant MRL. Any extralabel use in laying flocks or breeder birds creates egg residues that are not covered by the broiler withdrawal period.
Nicarbazin premix is considered stable in mash feed and in pelleted broiler feed under standard pelleting conditions. Conditioner temperatures above 85°C for more than 60 seconds can reduce assay recovery by partial dissociation of the DNC–HDP complex or steam stripping of the HDP component; published data for specific conditioner configurations is limited, and feed mills should validate post-pelleting HPLC assay before shipping. Moisture uptake above 12% in the premix can accelerate caking and non-uniform flow in micro-ingredient systems. Storage should be in closed containers below 25°C; if floor stock is exposed to relative humidity above 60%, the material should be used promptly rather than re-dried, because drying can segregate the active complex from the carrier. Chemical incompatibility is also relevant: strongly alkaline or strongly acidic feed matrices may destabilize the complex, and blending with oxidizing agents should be avoided. For finished capsules or tablets, a loss on drying above 2% before compression can cause picking and sticking, while excessive drying below 0.5% may increase static charge and reduce flow. Packaging for the 25% premix is typically 25 kg multiwall paper bags with a polyethylene liner; the 98% API is commonly packaged in 25 kg fiber drums with double polyethylene liners. The retest interval is often set at 24 months under controlled conditions at 10–25°C and protected from light; if retest intervals differ on the certificate of analysis, that document governs. Individual manufacturing sites should confirm these boundaries through batch records and stability programs.
