| HS Code | 454671 |
| Product Name | Monensin Veterinary Grade API |
| Applicable Dosage Forms | Tablets; Injections; Capsules; Powders; Granules; Premix; Solutions |
| Chemical Name | Monensin sodium |
| Molecular Formula | C36H61NaO11 |
| Molecular Weight | 692.85 g/mol |
| Cas Number | 22373-78-0 |
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in methanol, ethanol, acetone, ethyl acetate and chloroform; practically insoluble in water |
| Melting Range | 263-285 °C (decomposes) |
| Loss On Drying | ≤ 5.0% |
| Assay | ≥ 90.0% on dried basis (HPLC) |
| Heavy Metals | ≤ 20 ppm |
| Residual Solvents | Meets ICH Q3C limits |
| Storage Conditions | Store in tightly sealed containers, protected from light and moisture, below 25 °C |
| Pharmacological Class | Ionophore polyether antibiotic; anticoccidial and growth-promoting agent |
As an accredited Monensin 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 | Monensin Veterinary Grade API is packaged in sealed, light-resistant drums to ensure stability; available in 25 kg quantities. |
| Container Loading (20′ FCL) | 20′ FCL container loaded with Monensin Veterinary Grade API in sealed drums/cartons on pallets, securely braced, ventilated, and sealed for safe transport. |
| Shipping | Our shipping ensures compliant, secure transport of Monensin Veterinary Grade API in temperature-controlled, sealed containers. We adhere to international regulations, using labeled, tamper-evident packaging to prevent cross-contamination. Real-time tracking and documentation guarantee safe, on-time delivery for all downstream formulations. |
| Storage | Store Monensin Veterinary Grade API in a cool, dry, well-ventilated area, protected from light and moisture. Keep containers tightly closed and sealed when not in use. Avoid exposure to excessive heat, ignition sources, or oxidizing agents. Maintain controlled room temperature (20–25°C) with low humidity. Follow manufacturer’s guidelines for stability and expiration to ensure product potency and safety. |
| Shelf Life | Shelf life is typically 24 months when stored in original, tightly closed containers, protected from light and moisture. |
In feed-mill premix operations, monensin sodium is processed as a geometric dilution because direct addition of API to a final batch at gram-per-tonne levels produces unacceptable assay skew and segregation risk. The API is first pre-milled through a screen mill fitted with a 0.5 mm round-holed screen to break dense aggregates, then blended with a carrier of ground corn cobs, calcium carbonate, or rice hulls in a horizontal ribbon mixer of 500–2,000 kg working capacity. The first dilution is performed in a bin blender: 1 part monensin sodium activity is combined with 9 parts carrier and mixed for 10 minutes at 15 rpm. This preblend is transferred to the main mixer through a split butterfly valve to minimize aerosol release. Main blending continues for 20–30 minutes until assay results from 10 sampling points meet a relative standard deviation not exceeding 5.0%. Mineral oil is sprayed at 1–2 wt% during the final mixing phase to fix API particles to the carrier and reduce electrostatic dust drift. Finished premix concentrations are batch-sized to deliver 90–110 ppm monensin in broiler complete feed or 5–30 g/ton for growing cattle under 21 CFR 558.355. Dedicated equipment is mandatory; monensin sodium is highly toxic to equines and cross-contamination from a single batch must be prevented through validated cleaning, sealed transfer, and separate storage. End products include broiler coccidiostat feeds, feedlot cattle efficiency feeds, and dairy transition rations. Sampling and acceptance testing follow ISO 6497 and the medicated feed CGMP principles of 21 CFR 225.
| Species / Production Class | Published Inclusion Range | Reference Framework |
|---|---|---|
| Broiler chickens | 90–110 mg/kg complete feed | 21 CFR 558.355, local registrations |
| Growing cattle | 5–30 g/ton of 90% dry matter | 21 CFR 558.355 |
| Dairy cows | 11–22 g/ton dry matter | 21 CFR 558.355 |
| Goats | 10–30 g/ton complete feed | Country-approval labels |
Oral powder formulations for calves, lambs, and goats contain monensin sodium dispersed in lactose monohydrate, dried skim milk, or calcium carbonate. The dry blend is sieved through a 500 µm stainless-steel screen before tumble mixing in a V-blender at 12–18 rpm for 15–25 minutes. Potency targets of 20 mg/g and 60 mg/g are adjusted for scoop-based dosing in the field. Moisture is held below 2.0% to limit hydrolysis of the ionophore ring. Packaging in aluminium foil laminate sachets with desiccant protects the powder at ambient relative humidity above 65%. End product: calf and lamb oral coccidiostat powder for administration in milk replacer or top-dressed onto starter feed.
Granules are produced by wet granulation when dust control and flowability in automatic oral dosing machines justify the additional process step. A dry blend containing monensin sodium, maize starch, lactose, and 5 wt% hydroxypropyl methylcellulose is granulated in a high-shear mixer. Impeller speed is set between 150 and 300 rpm, chopper speed between 1,500 and 3,000 rpm, and granulation time between 4 and 8 minutes. Water or a 10% w/w povidone solution is added until a wet mass with endpoint torque within 20% of baseline is formed. The wet mass is extruded through a 0.8–1.2 mm screen and spheronized at 600–900 rpm. Drying is performed in a fluid-bed dryer with inlet air at 50–60°C to a loss on drying below 1.5%. Dried granules are separated through 200 and 850 µm sieves. Dissolution is evaluated in USP <711> Apparatus II at 50 rpm using phosphate buffer pH 6.8; acceptance is not less than 75% monensin released at 45 minutes. Equipment settings must be confirmed against the selected binder viscosity; published data for this specific monensin granulation configuration is limited. The granule form is packed into sachets for group treatment of lambs. This form reduces operator dust exposure compared with unagglomerated powder and improves dose uniformity in field mixing.
Tablets and rumen boluses are formulated from the granulated intermediate to avoid direct-compression segregation and unacceptable content uniformity drift. For oral tablets, the granule is blended with microcrystalline cellulose 20 wt%, sodium starch glycolate 2 wt%, colloidal silicon dioxide 0.5 wt%, and magnesium stearate 0.75 wt%. Compression is carried out on a rotary tablet press with 10–16 stations to hardness 80–120 N. Friability is checked according to USP <1216>; the limit is below 1.0%. Tablet potency is typically 100 mg monensin activity per unit. For rumen boluses, the granule is combined with ethylcellulose and polyethylene oxide and compressed into a larger cylindrical die. Erosion-controlled release is tested in simulated rumen fluid at 39°C; release duration is adjusted to 12–48 hours. Direct compression is avoided because monensin sodium has poor flow and low bulk density; high-shear granulation is mandatory for content uniformity. End products: oral tablets for calf coccidiosis and long-acting rumen boluses for cattle.
Because daily oral dosing creates labour bottlenecks in large dairy herds, hard gelatin capsules filled with monensin sodium pellets are used for single-dose intra-ruminal delivery. Pellet cores are made by extrusion-spheronization with microcrystalline cellulose 40 wt% and lactose. The pellets are coated with ethyl cellulose in a Wurster fluid-bed coater at inlet temperature 50–60°C and spray rate 5–10 g/min. Coated pellets are filled into size 12 veterinary capsules. Release testing in buffered rumen fluid pH 6.4 shows an initial release of approximately 20% by 6 hours and 80% by 24 hours. Capsules are administered with a balling gun to reduce esophageal injury and ensure the capsule remains in the reticulorumen. Formulation must avoid pellet swelling before administration; capsules are therefore stored below 25°C and protected from moisture. End product: controlled-release monensin capsule for transition dairy cows.
In small ruminant drenching programmes, monensin sodium is compounded as a non-aqueous oral solution because the ionophore has low water solubility and acid sensitivity. The vehicle contains propylene glycol, polysorbate 80, benzyl alcohol, and a citrate buffer adjusted to pH 6.0–7.5. A concentrate is prepared at 6–12% w/v monensin activity. The solution is clarified through a 1 µm polypropylene cartridge filter and filled into HDPE bottles. Low-shear mixing is maintained during compounding to limit air entrainment and oxidative degradation. Storage is below 25°C in light-protected containers. Drench syringes are calibrated per body weight according to approved local label; dose calculation errors are a known risk factor in field use. End product: oral drench for lambs and calves.
Monensin sodium injection is not established as a routine veterinary product in major markets, and published data for this specific configuration is limited. The sodium salt has low aqueous solubility; parenteral solvents such as polyethylene glycol 400, propylene glycol, or dimethylacetamide are required for experimental formulations. These vehicles may produce hemolysis and injection-site necrosis. The narrow therapeutic index of monensin increases the risk of cardiac and skeletal muscle toxicity if systemic exposure overshoots the intended range. Aseptic preparation of an experimental injectable requires sterilizing-grade filtration through a 0.22 µm membrane or gamma irradiation of the API before filling in an ISO 5 clean zone. Terminal steam sterilization is unsuitable due to heat sensitivity. The absence of approved injectable monensin products means that any development programme must generate its own pharmacokinetic and local tolerance data under veterinary regulatory guidance. End product: experimental injectable, generally avoided in favour of oral and intraruminal delivery.
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Monensin sodium crystalline API, assigned CAS 22373-78-0 and empirical formula C36H61NaO11, relative molecular mass 692.85 g/mol, is the unformulated ionophoric polyether active substance used for veterinary tablets, capsules, non-aqueous injections, oral solutions, powders, granules, and medicated feed premixes. The product model corresponds to the pharmacopoeial-grade sodium salt of monensin A, recovered from controlled fermentation of Streptomyces cinnamonensis by solvent extraction and crystallization. It appears as a white to almost white, hygroscopic crystalline powder. The material is freely soluble in methanol and chloroform, sparingly soluble in ethanol, and practically insoluble in water; this solubility profile determines the formulation route for each dosage form. The USP Monensin Sodium monograph controls assay at 90.0–102.0% on the dried basis. Identity is confirmed by infrared absorption against a reference spectrum and by HPLC retention time. Orthogonal controls include residual solvents by USP <467>, elemental impurities by USP <232>/<233> aligned with ICH Q3D, microbial limits by USP <61>/<62> for nonsterile oral dosage forms, water content by USP <921>, and particle size by USP <429> as a supplier-defined specification. Unlike lasalocid and salinomycin, monensin sodium exhibits narrow Na⁺-selective ionophoric behaviour, and in the United States its medicated feed uses are regulated under FDA 21 CFR 558.355.
Because pharmacopoeial monographs do not set a single harmonised particle-size limit for monensin sodium, the certificate of analysis is matched to the intended manufacturing step. Compliance parameters are summarized below.
| Parameter | Method / Standard | Acceptance or Purpose |
|---|---|---|
| Assay | HPLC, USP Monensin Sodium | 90.0–102.0% on dried basis |
| Identification | Infrared absorption, USP <197> | Matches reference spectrum |
| Residual solvents | USP <467> | Class 2 and Class 3 solvents within stated limits |
| Elemental impurities | USP <232>/<233>, ICH Q3D | Route-specific limits for veterinary oral or parenteral use |
| Microbial limits | USP <61>/<62> | Nonsterile oral drug product limits |
| Water content | Karl Fischer, USP <921> | Supplier specification; moisture protection required |
| Particle size | Laser diffraction, USP <429> | Supplier specification matched to dosage form |
Moisture protection is the central stability control for the unformulated API. The material is packaged in double food-grade polyethylene liners inside a sealed aluminum-laminated bag, and storage areas are maintained at controlled room temperature and below 60% RH. Dispensing is performed in closed transfer booths under negative pressure because the powder is aeratable and becomes a cross-contamination hazard. Open containers are returned to moisture-proof closure immediately after use, because hygroscopic uptake can cause aggregation, assay drift, and non-uniform distribution during subsequent blending.
Tablet manufacture of monensin sodium is constrained by low drug loading, hygroscopicity, and the hydrolytic sensitivity of the polyether lactone. Dry blending with roller compaction is preferred; direct compression is feasible only when the API charge is small and the excipient matrix has adequate flow. Wet granulation introduces water activity and is avoided unless the granulating fluid is non-aqueous. If wet granulation is used, drying in a fluid-bed dryer or vacuum dryer at product temperature not exceeding 50 °C protects assay. Content uniformity is evaluated under USP <905>, and dissolution is assessed under USP <711> with a surfactant-containing medium because of the aqueous insolubility of the API.
Tablet excipients generally include microcrystalline cellulose, anhydrous lactose or dibasic calcium phosphate, croscarmellose sodium, and 0.5 wt% magnesium stearate. The API is first premixed with a portion of the filler for 5–10 min in a low-shear blender to prevent segregation before addition of disintegrant and lubricant. Capsule filling uses tamping pin or dosator machines; the powder blend is held below 45% RH to avoid sticking and weight variation. Published production-scale data for monensin sodium tablet and capsule formulations are limited; process parameters must be validated for the specific turret speed range, punch dimensions, and filling equipment used.
Powder and granule forms are produced by spray-coating or granulation onto lactose, sucrose, or corn cob carriers. If the resulting granule D50 is below 180 µm, dust generation increases and containment becomes critical; if D50 exceeds 800 µm, segregation in final feed or dry blend is probable. These boundaries are process-specific and are confirmed by blender uniformity studies using a validated HPLC method. Granulated intermediates may be milled to 250–425 µm for controlled blending with feed carriers; no pharmacopoeial D50 harmonisation exists for this grade.
Solution-based dosage forms require a co-solvent system. Oral drenches and solutions for ruminants commonly use propylene glycol, ethanol, or polyethylene glycol 400 as primary vehicles; aqueous dilution is possible only within a narrow cosolvent and pH range. The ionophore is acid-labile, so solution pH is buffered in the neutral to mildly alkaline range; precipitation of the free acid occurs if pH falls below the carboxylic acid pKa. Forced-degradation studies at pH 3.0, pH 10.0, and 80 °C for short exposure define the solution stability window. Light protection is applied because polyether ionophores can be photolabile in dilute solution.
Injectable monensin sodium is restricted by a narrow therapeutic index and local tissue intolerance. The API is not generally approved as a conventional aqueous parenteral in food-producing species; any injectable prototype must show no precipitation on dilution with plasma, sterility under USP <71>, bacterial endotoxin compliance under USP <85>, and particulate matter control under USP <788>. Terminal steam sterilization may destroy the ionophore; sterilizing filtration through a 0.22 µm membrane is used for a non-aqueous vehicle. The same solubility constraints apply to capsules and tablets prepared with liquid components; a non-aqueous granulating agent can be used to produce granules without introducing water.
Medicated premix manufacture is the dominant use of monensin sodium veterinary-grade API. Under FDA 21 CFR 558.355, approved complete feed use levels are species-dependent; broiler chicken feed for coccidiosis prevention commonly falls in the range 90–110 g/ton, and feedlot cattle rations for feed efficiency and coccidiosis control may use 5–30 g/ton, depending on the specific label. These are regulatory ranges and require dilution of a type A medicated article in validated mixing equipment. The API is normally pre-blended onto a dry carrier such as ground corn cob, soybean hulls, or rice hulls at carrier moisture not exceeding 12%. Horizontal ribbon mixers or paddle mixers with capacities from 500 L to 2,000 L are common; after blending, a homogeneity study is performed with multiple sampling points using HPLC. A coefficient of variation below 5% is commonly used as an in-house release criterion, although no harmonised CV limit exists. Because monensin sodium is highly toxic to equines, cross-contamination prevention is a licensing requirement; dedicated lines, validated wash-in-place procedures, and separate storage are necessary.
Powders for direct oral use are diluted with lactose or mineral carriers and frequently packed in unit-dose sachets; the same blending and retention-sampling principles apply. Granules for feed admixture are usually non-dusty and free-flowing to allow accurate metering into a type C complete feed.
Monensin sodium is a monovalent polyether ionophore with Na⁺ selectivity greater than K⁺; salinomycin shows the opposite selectivity, and lasalocid is broader, complexing divalent and organic cations. These differences are not merely analytical: monensin in the rumen inhibits Gram-positive bacteria, increases propionate molar proportion, and reduces methane per unit of feed intake, while lasalocid and salinomycin have different bacterial susceptibility patterns and dose-response profiles. Therefore monensin sodium cannot be replaced by lasalocid sodium or salinomycin sodium at equal inclusion rates without a new veterinary drug filing.
The API is also distinct from synthetic non-ionophoric anticoccidials such as nicarbazin and decoquinate. Monensin sodium is fermentation-derived, so its impurity profile includes fermentation-related ionophore fractions; the USP monograph and HPLC methods resolve monensin A from related components. Finished feed analysis requires extraction, solid-phase cleanup, and HPLC with post-column derivatisation or mass spectrometric confirmation. The acceptance of monensin sodium in final premix or feed is determined by label claim and the FDA 21 CFR 558.355 medicated feed rules, not by harmonised human pharmaceutical standards. Manufacturers should retain the certificate of analysis, moisture-barrier packaging documentation, and cleaning-validation records for each batch because veterinary GMP inspections focus on cross-contamination and potency homogeneity.
