| HS Code | 814041 |
| Product | Monensin Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Active Ingredient | Monensin sodium |
| Cas Number | 22373-78-0 |
| Molecular Formula | C36H61NaO11 |
| Molecular Weight | 692.84 g/mol |
| Physical Form | White to off-white crystalline powder |
| Solubility | Soluble in methanol, ethanol, acetone, chloroform and dimethyl sulfoxide; practically insoluble in water |
| Melting Point | 267-269 °C (decomposes) |
| Therapeutic Category | Anticoccidial ionophore polyether antibiotic |
| Mechanism Of Action | Cation-selective ionophore that disrupts transmembrane ion gradients, leading to coccidial and bacterial cell death |
| Target Species | Cattle, sheep, goats, pigs and poultry depending on formulation |
| Primary Indications | Prevention and control of coccidiosis; improvement of feed efficiency and weight gain |
| Premix Concentration | Typically available as 10%, 15%, 20%, 40% or 80% monensin sodium in feed premix |
| Storage Conditions | Store in tightly closed, light-resistant container in a cool, dry place away from moisture and direct sunlight |
| Shelf Life | Typically 24 months from date of manufacture under recommended storage conditions |
| Withdrawal Period | Zero to 5 days for poultry and up to 7 days for cattle depending on regulatory label |
| Safety Profile | Narrow safety margin; overdose may cause anorexia, muscular weakness, ataxia, respiratory distress and cardiac failure |
As an accredited Monensin 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 | Packed in sealed multilayer kraft bags with inner polyethylene liner, 25 kg net per bag, for veterinary pharmaceutical manufacturing use. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Monensin Premix Veterinary Grade API: packed in sealed bags/cartons on pallets, properly secured for safe transport. |
| Shipping | Monensin Premix is shipped in sealed, moisture-proof containers to preserve stability. Transport complies with hazardous goods regulations, with proper labeling and documentation. Avoid exposure to heat, humidity, and static. Use grounded equipment and protective gear during handling. Deliveries follow temperature-controlled logistics to maintain product integrity throughout transit. |
| Storage | Store Monensin Premix Veterinary Grade API (tablets, injections, capsules, powders, granules, premixes, solutions) in tightly sealed original containers in a cool, dry, well-ventilated area. Protect from light, moisture, and excessive heat. Keep away from oxidizing agents and incompatible materials. Maintain controlled room temperature, avoid freezing, and use before expiry. |
| Shelf Life | Shelf life: 24 months from manufacture when stored in original sealed container, below 25°C, protected from light and moisture. |
In broiler integrator feed mills, monensin sodium premix is handled as a medicated article rather than a commodity ingredient. The addition of a 10% w/w monensin sodium Type B premix at 1.0–1.2 kg/tonne finished feed produces 100–120 mg/kg active monensin in broiler starter and grower rations, the band most commonly used for coccidiosis suppression under FDA 21 CFR §558.355 and the EU Register of Feed Additives established under Regulation (EC) No 1831/2003. A feed mill producing medicated feed must operate under 21 CFR Part 225 or equivalent and maintain HACCP verification according to ISO 22000:2018; sampling frequency follows ISO 6497:2005. In production, the monensin premix is first diluted into a ground maize carrier with a paddle mixer achieving a coefficient of variation below 5%, then introduced via the micro-ingredient line into the main double-ribbon mixer after limestone and dicalcium phosphate have been blended but before liquid fat is applied. Steam conditioning is held at 80–85 °C for 15–30 s ahead of a 3.5 mm die pellet press; crumble rolls reduce 3.5 mm pellets to 1.0–1.5 mm crumbles for starter feeds. The terminal forms are broiler starter, grower, and finisher crumbs or pellets, with pellet durability index checked against a ≥95% PDI target. Moisture-liberating ingredients such as choline chloride are not held in direct contact with monensin premix for more than 48 h in the pre-mix bin because published kinetic data on monensin degradation under alkaline, high-moisture micro-environments is limited and current practice segregates the two streams.
For high-density beef finishing rations, monensin sodium is not top-dressed; it enters the mixing stream as a diluted Type B medicated article or mineral premix. FDA 21 CFR §558.355 permits cattle feed applications when the Type A 90 g/lb monensin sodium article is further mixed to produce finished feed; regional label allowances for beef cattle commonly express intake as 50–200 mg/head/day. Complete feed inclusion is calculated from predicted dry-matter intake and typically falls between 10 mg/kg and 40 mg/kg on a 90% dry-matter basis. The production sequence in a horizontal reel mixer begins with 20–30% of the cracked maize and all dry mineral fractions, followed by the monensin mineral premix dispersed onto the dry mineral carrier, then the remaining maize, dried distillers grains, and protein meals. Dry mixing time is 3–5 min at a rotor speed that achieves a coefficient of variation of ≤5% in tracer studies conducted according to ISO 6497:2005. Liquid molasses or stored fat is applied only after the dry mix has reached homogeneity because early liquid addition coats the monensin carrier and retards dispersion. Vertical mixer wagons used on feedlots require particular attention: dead zones at the bottom cone can retain concentrated monensin fines and create hot spots if not cleaned between batches. The terminal product classes include complete total mixed rations, pelleted beef supplement cubes at 10–25 mm diameter, and meal-type range supplements. Mixer wagons with load-cell accuracy of ±1% are used on feedlot scales to verify daily delivery against the approved intake band; batch-to-batch variance is managed by retaining a minimum of three composite samples per 50 t and assaying carrier uniformity before release.
Monensin sodium shifts ruminal fermentation toward propionate and is used in transition and lactating dairy cow rations to improve glucose economy and reduce subclinical ketosis pressure. Under FDA 21 CFR §558.355, lactating dairy cow feeds may contain monensin sodium at 11–22 g/ton of complete feed on a 90% dry-matter basis, providing approximately 150–300 mg/head/day when dry-matter intake is 13.6 kg; milk production efficiency claims are label-restricted. In the European Union, the use in dairy cows is controlled through the feed additive authorization under Regulation (EC) No 1831/2003 and residue limits established in Commission Regulation (EU) No 37/2010. Manufacture of transition dry cow and fresh cow grain mixes typically uses a 5% monensin sodium premix metered at 220–440 g/tonne into a double-ribbon mixer or paddle mixer; the premix is dry-blended with ground maize and soybean hulls before steam-flaked corn and molasses are added. Mix time is 3–4 min after the premix addition to reach a coefficient of variation of ≤5%, and the batch is then transferred by bucket elevator rather than pneumatic line to reduce particle segregation. The terminal products are fresh cow pelleted grain mixes, transition TMR concentrates, and component feeds for farm TMR preparation. Overprocessing in a horizontal mixer with a fill level above 80% can cause monensin fines to coat the mixer wall and produce low-assay areas in the subsequent batch; wall scraping between batches is critical. Published digestibility and milk fat data are specific to the label-approved feeding rate, and responses below 11 g/ton are not claimed.
Meat and dairy goat kid starters are pelleted in smaller production runs and use lower monensin sodium inclusion bands than broiler or beef feeds. Under FDA 21 CFR §558.355, confined goat feeds may use monensin sodium at 20–30 g/ton complete feed (20–30 mg/kg) for coccidiosis prevention, with a label warning against equine exposure. A feed mill producing 1–3 t batches uses a horizontal ribbon mixer with a 60-s dry pre-mix step in which monensin sodium is first blended with ground corn or soybean meal at a 1:9 ratio before being metered into the main batch. Steam conditioning is held at 70–75 °C for 10–15 s because goat kid starter formulations often contain whey powder and high lactose levels that plasticize at higher temperatures and plug the pellet die. Pellets are formed through a 3.0 mm die, then crumbled through a roller gap of 0.5–1.0 mm to produce 1.0–1.5 mm kid starter crumbles. Terminal product types include pelleted kid starters, texturized creep feeds, and mineral-containing meal supplements for small-run farm mills. If the mill also produces horse feeds, the line must be flushed with 5–10 kg of ground maize after each medicated batch, and flush material is labelled as medicated feed rather than discarded into horse lines.
Controlled-release intraruminal devices represent a non-feed route that removes daily mixing variability but demands tight control of device orifice geometry and matrix hydration. A commercial cattle device contains 32.4 g monensin sodium and releases approximately 335 mg/day for about 100 days, with zero-order release maintained by the interaction between a compressed matrix core and a rate-limiting opening in the ethylene-vinyl acetate tube. Regulatory oversight follows the veterinary medicinal product framework in the destination market; in the EU, monensin residues are assessed under Commission Regulation (EU) No 37/2010 Table 1, and manufacturing follows EudraLex Volume 4 GMP for veterinary medicinal products. The fabrication sequence for the matrix core involves blending monensin sodium with a high-molecular-weight water-swellable polymer and hydrophobic binder, dry granulation or roller compaction to a defined bulk density, and compression into cylindrical cores with a diameter tolerance of ±0.2 mm. The core is inserted into an activated polymer tube fitted with retention wings; release rate is set by exposed core surface area, polymer hydration rate, and orifice diameter rather than by feed dilution. Terminal product type is a winged continuous-release intraruminal capsule for grazing and confined cattle. Published equipment-level data for the exact polymer blend and compression force settings of the commercial device are limited; process development must therefore verify release rate in pH 6.8 buffer at 39 °C using USP apparatus 4 flow-through cell. Conventional immediate-release monensin sodium tablets are not marketed for food-producing animals, and injectable presentations are not a recognized veterinary use; accidental parenteral exposure produces severe cardiac and skeletal muscle toxicity.
Monensin sodium has low aqueous solubility and is incorporated into liquid feed supplements as a stabilized suspension rather than a true solution. Under FDA 21 CFR §558.355, liquid feed supplements are regulated as medicated feeds and require a medicated feed mill license under 21 CFR Part 225; label directions must prevent uneven intake. A typical liquid supplement formulation contains 200–400 mg/kg monensin sodium, fed at 0.5 kg/head/day to deliver 100–200 mg/head/day; consumption above 0.5 kg must be rationed via lick-wheel calibration. Production uses a two-stage dispersion process: monensin sodium is first sheared into warm soybean oil or ethoxylated castor oil at 35–45 °C using a high-shear disperser at 1,500–3,000 rpm, then metered into molasses diluted with water at 40–50 °C. An in-line rotor-stator mixer recirculates the tank contents for 20–30 min until a visual suspension remains stable over a 24-h quiescent period; viscosity is measured at 25 °C with a Brookfield viscometer spindle LV3 at 12 rpm and adjusted to 800–1,200 mPa·s to prevent sedimentation without impeding pump transfer. Terminal product types include molasses-based liquid supplement tanks, carrier suspensions for farm feed delivery, and liquid blend intermediates for feed-mill surge bins. Bulk tank recirculation lines must operate at low shear to avoid particle attrition; a gear pump is preferable to a centrifugal pump because the latter can break the suspension and deposit monensin fines at the tank bottom. True aqueous solutions for drinking water use are not a recognized route for monensin sodium; if a purchaser specifies an oral solution, the formulation must be redeveloped as a non-aqueous or surfactant-stabilized suspension with solubility data generated in the target matrix. Parenteral use is outside approved product types, and monensin sodium should not be milled or dissolved in injectable vehicles absent a specific authorized dossier.
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The veterinary active pharmaceutical ingredient described here is designated Monensin Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions. The material is a fermentation-derived polyether ionophore obtained from Streptomyces cinnamonensis and refined to a white to off-white crystalline powder. The primary chemical entity is monensin sodium, C36H61NaO11, CAS 22373-78-0, with a nominal molecular weight of 692.85 g/mol; the corresponding free acid, monensin A, is CAS 17090-79-8 with a molecular weight of 670.87 g/mol. The model designation denotes an assay-adjusted veterinary-grade API, not a finished feed or diluted commercial premix. A manufacturer-specific nominal activity code such as Vet-API-MN-90 is used for material released against a 90.0% monensin sodium content. The same crystalline substance can be classified, milled, or spray-dried to different particle-size cuts for tablets, capsules, powders, granules, low-dusting feed premixes, and non-aqueous solution development.
Compendial quality for monensin sodium is anchored to current USP and Ph. Eur. monographs, with supporting tests drawn from USP <731>, USP <921>, USP <281>, Ph. Eur. 2.2.24, and Ph. Eur. 2.2.32. Feed-use registration in cattle, poultry, and goats is subject to national approvals; monensin-containing feed is regulated in the United States under 21 CFR 558.355. Parenteral injection is not a standard labelled route for monensin in food-producing animals and is limited to research or custom veterinary formulations where local regulatory provisions permit. Route-specific differences are therefore critical: a feed-premix grade is not automatically suitable for parenteral compounding unless endotoxin, subvisible particulate, and residual solvent criteria are independently verified.
Downstream refinement of monensin sodium begins with solvent extraction of whole broth or filtered mycelia, followed by concentration, pH adjustment, crystallization, centrifugation, and vacuum drying. The extraction train removes polar fermentation metabolites, residual lipids, and protein-derived color bodies. A production-scale batch nevertheless retains milligram-level variability in crystal habit and bulk density; therefore release testing includes attributes that influence blending and tableting. The following representative control limits are applied to the bulk veterinary grade before subdivision into route-specific sublots.
| Attribute | Control limit | Test method / standard |
|---|---|---|
| Identification | Infrared absorption concordant with reference standard | USP <197>; Ph. Eur. 2.2.24 |
| Assay (monensin sodium) | 90.0–102.0% on dried basis | HPLC with post-column derivatization; USP Monensin Sodium monograph |
| Potency (premix release) | 900–1020 µg/mg monensin activity | HPLC with vanillin-sulfuric acid derivatization at 520 nm |
| Loss on drying | ≤4.0% | USP <731>; Ph. Eur. 2.2.32 |
| Water content | ≤3.0% for parenteral-destined sublots | USP <921>; Ph. Eur. 2.5.12 |
| Residue on ignition | ≤2.0% | USP <281>; Ph. Eur. 2.4.16 |
| Bulk density | 0.35–0.55 g/cm³ | USP <616>; Ph. Eur. 2.9.34 |
| Particle size D90 | ≤150 µm for direct-blend premix | Laser diffraction, ISO 13320:2020 |
| Total aerobic microbial count | ≤100 CFU/g | USP <61>; Ph. Eur. 2.6.12 |
| Bacterial endotoxins | ≤0.50 EU/mg for injectable-compounding grade | USP <85>; Ph. Eur. 2.6.14 |
| Residual methanol | ≤3000 ppm | USP <467>; ICH Q3C |
The assay method uses post-column derivatization because the monensin chromophore is weak; vanillin in acidic methanol reacts with the polyether backbone to form a red-violet adduct with absorbance from 510 nm to 540 nm. Quantification is normally performed at 520 nm. The residual solvent and endotoxin limits in the table are not universal; they are tightened or relaxed only when supported by the intended route, dose, and species-specific regulatory file.
Monensin is delivered in complete feed at low mass fractions. In poultry coccidiosis control, typical monensin concentrations in finished feed are 90–125 mg/kg; in beef and dairy rations, monensin is often used at 200–360 mg/head/day in confined production systems, with exact inclusion rates determined by registered label claims and production class. Because the active mass fraction is small, blending is the central process risk. Field measurements on 2000 L ribbon blenders show that assay variability rises when the mixer is filled below 40% or above 70% of working volume, and when the loaded carrier has a wide particle-size span. Segregation occurs during discharge into bulk bins if a fine active fraction is not bound to the carrier by electrostatic or moisture-mediated adhesion.
For tablet and capsule intermediates, the API is commonly dry-blended with microcrystalline cellulose, lactose monohydrate, and sodium starch glycolate using geometric dilution before lubrication with magnesium stearate. A D90 of 75–150 µm is preferred for direct compression; cohesive agglomerates larger than 250 µm reduce content uniformity below the acceptance values of USP <905>. High-shear wet granulation is possible but requires careful binder selection because monensin sodium can form pastes in aqueous systems and may partition into the liquid phase during drying. When wet granulation is unavoidable, non-aqueous granulation with anhydrous ethanol or isopropanol shortens drying and reduces bead hardening.
Parenteral preparations containing monensin sodium are not interchangeable with oral feed premixes. Injectable compounding demands a separate grade with low endotoxin burden and controlled subvisible particulate matter. Use of a 0.2 µm sterilizing filter in a 316L stainless-steel filling line is typical for heat-labile formulations; if terminal autoclaving is proposed, thermal stability data must be generated because published degradation kinetics for aqueous monensin sodium under saturated steam at 121 °C are limited. Endotoxin acceptance for high-dose parenterals is typically tightened to ≤0.25 EU/mg or lower depending on the intended monensin dose per kilogram body weight. Subvisible particle counts are evaluated by USP <788>. Solutions for injection require non-aqueous or complexing vehicles because monensin free acid has poor aqueous solubility and can precipitate when pH falls below 8. Equine exposure is a significant safety incompatibility; monensin is not used in horse feed or parenteral products because accidental ingestion of low milligram quantities is associated with severe myocardial toxicity.
Thermogravimetric analysis of monensin sodium typically shows initial decomposition above 200 °C under nitrogen, but processing degradation can occur at much lower temperatures when the API is dissolved or suspended in moist excipient matrices. Fluid-bed drying of low-dose monensin granules is generally conducted at inlet air 55–65 °C and stopped at product moisture 2–4% to limit chemical loss and granule friability. Tray-drying above 70 °C has been associated with increased related substances in some wet-granulated batches, although published data across all granulation media is limited. For this reason, dry granulation by roller compaction or direct compression is preferred for tablets and capsules. When powders are packaged for feed premix intermediates, moisture ingress above 60% relative humidity can accelerate crystal bridging; bulk packaging therefore uses double polyethylene liners inside foil-laminated bags or fibre drums with desiccant.
The table below summarises the critical route-dependent quality parameters that separate the bulk veterinary grade from specific finished form requirements.
| Dosage form | Applicability | Critical control parameter | Reference method / standard |
|---|---|---|---|
| Feed premix | Primary registered use in poultry, cattle, and goats | Assay 90.0–102.0%, particle size D90 ≤150 µm, low dusting | USP <731>; ISO 13320 |
| Tablet / capsule | Suitable as dry-blend or dry-granulated intermediate | Content uniformity, compactability, bulk density 0.35–0.55 g/cm³ | USP <905>; USP <616> |
| Powder / granule | Intermediate for oral administration | Loss on drying ≤4.0%, sieve-cut consistency | USP <731>; USP <786> |
| Injection | Limited; non-standard route | Endotoxin ≤0.50 EU/mg, subvisible particles, residual solvents | USP <85>; USP <788>; ICH Q3C |
| Solution | pH-dependent; primarily non-aqueous development | Clarity, pH, free-acid precipitation at low pH | Ph. Eur. 2.2.3; USP <791> |
Monensin is frequently compared with salinomycin, narasin, and lasalocid, but substitution is not stoichiometric. Monensin sodium complexes monovalent cations with a selectivity order Na⁺ > K⁺; lasalocid, in contrast, also transports divalent cations and organic amines. The difference alters compatibility with certain mineral supplements: high dietary calcium does not saturate monensin activity in the same manner as lasalocid. In final feed formulations, monensin is typically used at 90–125 mg/kg for poultry coccidiosis prevention, whereas salinomycin and narasin are registered at slightly different inclusion ranges and host-safety margins. Monensin has a narrow therapeutic index in horses and should never be mixed into equine feeds; cross-contamination in multi-species milling facilities must be controlled by flush batches and batch-to-batch line cleaning. Differences from non-ionophore coccidiostats are even larger: monensin is not a synthetic chemical anticoccidial and does not share the same resistance-management rotation interval with triazine or nitromethylfuryl compounds.
Bulk monensin sodium veterinary API is commonly packed under nitrogen in double low-density polyethylene liners placed inside aluminium-laminated fibre drums. Storage is maintained at ≤25 °C and relative humidity below 60%; unopened shelf-life is assigned from stability data obtained under ICH Q1A(R2) conditions. For feed-premix customers, sublots are prepared by controlled milling and blending onto calcium carbonate or rice-hull carriers to a specified activity concentration, typically 10% or 20% monensin, before shipment. The carrier-loaded premix should not be stored in direct sunlight or mixed with bentonite-based binders without compatibility testing, because ion exchange on clay surfaces can reduce extractable monensin in feed matrices.