| HS Code | 372179 |
| Chemical Name | Maduramicin ammonium |
| Cas Number | 84878-61-5 |
| Molecular Formula | C47H83NO17 |
| Molecular Weight | 934.17 g/mol |
| Appearance | White or almost white crystalline powder |
| Solubility | Soluble in methanol, ethanol, acetone, and chloroform; practically insoluble in water |
| Veterinary Grade | Complies with veterinary pharmacopoeial standards |
| Melting Point | 165°C to 169°C |
| Storage Conditions | Store in a cool, dry place in tightly closed containers, protected from light |
| Shelf Life | 24 months from date of manufacture when stored under recommended conditions |
| Dosage Form Compatibility | Suitable for formulation into tablets, injections, capsules, powders, granules, premixes, and solutions |
| Ph Stability | Stable in neutral to slightly alkaline conditions; avoid strong acidic or alkaline environments |
| Recommended Application | Anticoccidial agent for veterinary use in poultry and livestock |
| Withdrawal Period | As per local veterinary regulations; typically 5 days for poultry |
As an accredited Maduramicin 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 | Maduramicin Premix Veterinary Grade API is packed in 25 kg sealed drums with inner polythene liners, ensuring stability and safe handling. |
| Container Loading (20′ FCL) | 20' FCL loading of Maduramicin Premix veterinary API, securely packed in sealed containers, ensuring safe transport and stability for pharmaceutical formulations. |
| Shipping | Shipped in sealed, moisture-resistant, light-protected containers with proper hazard labeling. Requires compliance with international dangerous goods regulations. Keep cool, dry, and away from incompatible materials. Avoid dust generation; use appropriate PPE. Not for human or animal direct consumption—veterinary premix manufacturing use only. |
| Storage | Store Maduramicin Premix Veterinary Grade API in its original, tightly sealed container in a cool, dry, well-ventilated area, away from direct sunlight, moisture, heat, and open flames. Maintain room temperature and avoid contact with incompatible materials. Keep out of reach of children and unauthorized personnel. Ensure container is clearly labeled and protected from physical damage. |
| Shelf Life | Shelf Life: 24 months from manufacture date, when stored sealed, dry, below 30°C, protected from light and moisture. |
Maduramicin premix veterinary grade API is supplied as a dried fermentation-derived polyether ionophore ammonium salt standardised for medicated feed application only. The downstream application scope is restricted to coccidiosis control in poultry, primarily broiler chickens and turkeys, because aqueous solubility is insufficient for reliable drinking-water solution compounding and the safety margin in non-avian species is too narrow for injectable or tablet dosage forms. Compound feed mills, integrated broiler operations, and licensed veterinary premix manufacturers are the three downstream sectors that handle the API at production scale. The active moiety is consumed only as a feed-additive premix, and every downstream formulation decision must reconcile the ionophore’s narrow therapeutic index, the regulatory maximum residue constraints of the destination market, and the physical stability of the carrier system.
Broiler coccidiosis prophylaxis in vertically integrated production uses maduramicin ammonium at 4.54 g per short ton to 5.45 g per short ton of complete feed, equivalent to 5 mg/kg to 6 mg/kg, as set out in FDA 21 CFR 558.555 for broiler chickens. The Type A medicated article is approved for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. The Type A article is diluted through a sequential Type B intermediate premix and Type C complete feed mixing chain; a 10% Type A article added at 50 g to 60 g per short ton yields the final target concentration. The production process at compound feed mills meters the Type A or Type B premix through micro-ingredient weigh hoppers into a horizontal ribbon mixer or twin-shaft paddle mixer with a tested coefficient of variation below 10% and a 2-minute to 4-minute dry mix step before fat or molasses addition. Terminal finished product types include mash, crumble, and pelleted broiler starter, grower, and finisher feeds. Operational boundary: tiamulin-containing medications must not be used concurrently because polyether ionophores and tiamulin can produce severe adverse interactions; verification of tiamulin carryover is required in shared manufacturing lines. Feeding to laying hens producing eggs for human consumption is not approved in the US; label withdrawal is 5 days before slaughter.
In European Union member states, maduramicin ammonium is registered for turkeys for fattening with a maximum complete feed content of 5 mg/kg and a 5-day withdrawal period under the Regulation (EC) No 1831/2003 feed additive framework. Turkey finisher feed manufacturing routes the premix through the same pre-pelleting mixing stage used for broiler feeds, but the conditioning temperature is typically maintained below 75°C when a 1% premix is used because published data for maduramicin ammonium recovery above 80°C in high-fat turkey rations is limited. The formulation addition in a 1% premix is 500 g per metric ton of finished feed to deliver 5 mg/kg active substance. Downstream production equipment includes a double-shaft paddle mixer followed by a pellet mill with 3 mm to 4 mm die openings; post-pelleting retention samples are analyzed by HPLC with post-column derivatization and UV detection at 520 nm to confirm final assay within 90% to 110% of label claim. Terminal finished product types are pelleted turkey grower and finisher feeds, typically containing 2% to 3% added fat. Carryover control limits for maduramicin ammonium in non-target feed should be established during cleaning validation; if the subsequent batch is a withdrawal feed, flushing with ground corn and calcium carbonate is used until assay falls below the validated limit of quantification.
| Regulatory frame | Target species | Maximum complete feed level | Withdrawal interval | Reference designation |
|---|---|---|---|---|
| United States | Broiler chickens | 4.54 g/ton to 5.45 g/ton (5 mg/kg to 6 mg/kg) | 5 days | FDA 21 CFR 558.555 |
| European Union | Chickens for fattening; turkeys | 5 mg/kg complete feed | 5 days | Regulation (EC) No 1831/2003 feed additive register |
| Codex Alimentarius | Not assigned | No MRL assigned | Importing-country verification required | CAC/MRL 2 |
Shuttle programs that rotate maduramicin ammonium with synthetic coccidiostats or nicarbazin require precise batch scheduling and cleanout verification in multi-species feed mills. In a typical ionophore-to-chemical shuttle for broilers, maduramicin ammonium is incorporated at 5 mg/kg complete feed during the starter phase, and the grower phase switches to a non-ionophore molecule; the premix addition is therefore 500 g of a 1% premix per metric ton, or 50 g of a 10% Type A article per metric ton. The production process uses a micro-ingredient weigh batcher with a minimum weighed quantity of not less than 2 kg per addition to avoid mass flow error at the final weigh hopper. Terminal finished product types include medicated starter feed in crumble form and non-medicated withdrawal grower finisher feeds. Compliance is anchored to FDA 21 CFR 558.555 in US broiler applications and to the applicable national registration for shuttle use; in EU shuttle programs, the withdrawal period of 5 days remains binding before slaughter. Analytical verification of maduramicin ammonium carryover below the validated limit of quantification in the subsequent withdrawal feed should be performed by HPLC-UV or LC-MS/MS after matrix spike recovery trials documented under ISO 17025:2017.
Granulated maduramicin premix is produced from the dried API by adsorptive blending onto a carrier such as calcium carbonate, limestone, or milled soybean hulls, followed by low-pressure compaction or granulation to reduce dust and improve flow. The addition ratio for a 1% granulated premix is 500 g per metric ton of complete feed to achieve 5 mg/kg maduramicin ammonium. For a 10% granulated Type A medicated article, the corresponding addition is 50 g per metric ton. Downstream production equipment in automated mills includes loss-in-weight screw feeders and micro-ingredient weigh hoppers with a minimum batch resolution of 0.1 kg; granule particle size is typically specified between 150 µm and 710 µm to minimise segregation in the mixer and to maintain bulk density between 0.65 g/cm³ and 0.90 g/cm³. Terminal finished product types are mash and pelleted broiler feeds where low inclusion accuracy is critical for residue compliance. Compliance is audited against FDA 21 CFR 558.555, Regulation (EC) No 1831/2003 feed additive provisions, and the feed safety management requirements of ISO 22000:2018, clause 8.5 for physical contamination control. The granulated premix should be stored below 30°C and below 60% relative humidity; loss on drying specification should be confirmed before use because hygroscopic carrier shifts can alter metering density.
In export markets where a foreign trade supplier delivers maduramicin ammonium as a concentrated Type A medicated article for licensed local premix manufacturers, the regulatory status of re-packing and dilution is jurisdiction-dependent. The concentrated Type A article is commonly standardised at 45.4 g per pound (10% w/w) under FDA 21 CFR 558.555, and the downstream licensee dilutes it with calcium carbonate or rice hulls to 1% or 2% intermediate premixes. The dilution process uses a ribbon mixer with a 95% fill working capacity and a 5-minute dry blend step, followed by sieving through 850 µm to remove agglomerates before packaging into 25 kg multi-wall paper bags with inner polyethylene liners. Terminal finished product types include licensed Type B intermediate premixes and branded Type C medicated feeds distributed through local compound feed mills. Compliance documentation required for export includes the certificate of analysis issued under ISO 17025:2017, a certificate of origin, and the current Good Manufacturing Practice audit report for the manufacturing site. Because maduramicin ammonium is highly toxic to horses and dogs, labelling and segregation in warehouses must comply with the target importing-country requirement; a dedicated forklift and separated quarantine area are common operational controls in re-packing facilities. Published data for specific national permit limits outside the US and EU should be verified against the importing-country compendium, and the absence of a Codex MRL for maduramicin residues should trigger pre-shipment consultation.
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Maduramicin ammonium (CAS 84878-61-5; relative molecular mass approximately 933.2 g/mol) is the ammonium salt of a monovalent glycosylated polyether ionophore produced by fermentation of Actinomadura yumaense. The veterinary-grade API is supplied as a white to off-white crystalline or microgranulated powder with a concentrate activity typically not less than 90.0% on the anhydrous basis. Model designations such as MAD-API-CRYSTALLINE and MAD-PREMIX-1.0 encode the physical form and the active loading; the premix is usually 1.0% maduramicin activity on calcium carbonate, ground corncob, or mineral-oil-treated carrier. The concentrated API is intended for further cGMP processing into tablets, capsules, powders, granules, premixes, or non-aqueous injectable solutions. The diluted 1.0% premix is intended exclusively for feed micro-ingredient dosing and is not a source of injectable active ingredient because of carrier particles and microbiological load.
No Ph. Eur., USP, or VICH monograph exists for maduramicin ammonium; release specifications are therefore established in the marketing-authorisation dossier and verified under GMP Part II and ICH Q7. The API is assayed by reverse-phase high-performance liquid chromatography against a characterized reference standard, and residual solvents, elemental impurities, and related substances are controlled under ICH Q3C and ICH Q3D. The following table summarizes typical release criteria for the crystalline API; individual batch certificates may include additional process-specific limits.
| Parameter | Method / standard | Typical acceptance criterion |
|---|---|---|
| Appearance | Visual examination | White to off-white powder |
| Identification | HPLC retention time against reference standard | Positive |
| Assay | HPLC, anhydrous basis | ≥ 90.0% w/w |
| Loss on drying | USP <731> / Ph. Eur. 2.2.32 | ≤ 5.0% |
| Sulfated ash | Ph. Eur. 2.4.14 | ≤ 5.0% |
| Residual solvents | ICH Q3C | Class 2 solvents within limits |
| Elemental impurities | ICH Q3D oral PDE | Pb ≤ 5 ppm, Cd ≤ 2 ppm, As ≤ 2 ppm, Hg ≤ 1 ppm |
| Particle size | Laser diffraction | Premix-grade API D90 ≤ 180 μm; micronized grade D90 ≤ 20 μm for suspension forms |
Mass balance is evaluated across assay, related substances, water, residual solvents, and sulfated ash. A reconciliation outside 98.0–102.0% triggers an investigation under the site’s deviation management system because it may indicate non-volatile impurity accumulation or an analytical bias. For premix release, the assay is performed on the diluted carrier blend and the label claim is 1.0%, with acceptance limits of 95.0–105.0% of label claim in many jurisdictions.
Stepwise geometric dilution is mandatory when the 1.0% premix is incorporated into final feed at 5–6 ppm maduramicin activity. In a production-scale horizontal ribbon mixer or double-shaft paddle mixer, the premix is first blended with a portion of ground maize, limestone, or wheat middlings to form a workable pre-blend, then added to the main mixer. Finished feed homogeneity is verified by tracer studies with a coefficient of variation not exceeding 10.0%. The low inclusion rate means that mixer carry-over, electrostatic adhesion, and sampling method contribute disproportionately to batch variance. Equipment should be earthed, and the granulation or blending suite is commonly maintained at 40–60% relative humidity to reduce static charge on the crystalline powder. Pneumatic transfer of the concentrated API is minimized because fines may adhere to transfer lines and produce assay drift. If the moisture content of the carrier exceeds 5.0%, the premix should be pre-dried or stored under dehumidified conditions before use because moisture can soften the carrier and increase cohesive flow failure.
For tablets and capsules, the concentrated API can be dry-granulated with microcrystalline cellulose, lactose monohydrate, and croscarmellose sodium; direct compression is feasible only when the API is micronized and pre-dispersed because cohesive fines segregate during hopper discharge. Content uniformity is assessed by Ph. Eur. 2.9.6 or USP <905>; a low-dose tablet acceptance value of ≤ 15.0 is a common in-process target. For granules and oral powders, top-spray fluid-bed granulation with povidone or hypromellose binder is used, and the inlet air temperature is kept below the softening point of the binder system. Injectable or drinking-water solutions require a non-aqueous or micellar carrier because the ammonium salt has low aqueous solubility; direct addition of crystalline API to drinking water without a solubilizer can produce sedimentation and dose variability. Sterile injectable formulations would require filtration and sterility assurance per Ph. Eur. 2.6.1 and bacterial endotoxin testing per Ph. Eur. 2.6.14, but published data for registered parenteral maduramicin products is limited.
Tiamulin hydrogen fumarate, a pleuromutilin, inhibits hepatic cytochrome P450-mediated biotransformation of polyether ionophores in poultry. For maduramicin, this interaction is clinically significant because the therapeutic index is narrow; even modest reductions in clearance can shift systemic exposure toward ionophore toxicity. The consequence is not a feed-stability incompatibility but a pharmacological incompatibility. Affected birds may show decreased feed intake, reduced weight gain, leg weakness, and in severe cases death due to skeletal muscle and cardiac damage. The registered feed label therefore prohibits simultaneous administration of tiamulin and maduramicin, and many quality systems require a washout period between feeds containing the two actives. In feed mills, this interaction drives sequencing rules: a batch containing maduramicin must not immediately precede or follow a tiamulin-medicated batch without validated line flushing and carry-over control. Cross-contamination limits under Regulation (EC) No 1831/2003 and associated carry-over legislation apply to coccidiostats in non-target feed; the operational target is commonly set below 1.0% of the previous batch, but the registered limit should be confirmed for each jurisdiction. This incompatibility also applies to medicated drinking water; if tiamulin is administered by water, maduramicin-containing feed may need to be withdrawn or replaced during therapy.
Maduramicin differs from monensin, salinomycin, lasalocid, and narasin in its high target-species potency and narrow species boundary. It is registered mainly for broiler chickens at 5–6 ppm complete feed, whereas monensin and lasalocid are used at considerably higher label concentrations and have broader approvals across cattle, sheep, and turkeys. The high mass-based potency of maduramicin means that weighing errors, mixer carry-over, and sampling variance have proportionally greater biological consequences than with lower-potency ionophores. This is the operational difference most relevant to feed manufacturing: segregation of a 1.0% premix at low addition rates can produce local feed concentrations far above the label range, whereas the higher inclusion rates of monensin or lasalocid provide greater dilution tolerance.
| Attribute | Maduramicin ammonium | Monensin sodium | Lasalocid sodium |
|---|---|---|---|
| Source organism | Actinomadura yumaense | Streptomyces cinnamonensis | Streptomyces lasaliensis |
| Primary cation selectivity | K⁺ / Na⁺ monovalent | K⁺ / Na⁺ monovalent | Broad, including Ca²⁺ |
| Typical broiler complete feed inclusion | 5–6 ppm | 90–110 ppm | 75–125 ppm |
| Species restriction | Broilers; not for laying hens producing eggs for human consumption | Broilers, turkeys, cattle, goats | Broilers, turkeys, cattle, sheep |
| Safety margin | Narrow | Moderate | Wider |
| Interaction with tiamulin | Severe | Significant | Significant |
The most consequential difference is not mode of action, because all polyether ionophores collapse transmembrane cation gradients in susceptible Eimeria; it is the combination of high potency and narrow therapeutic index. Cross-resistance between maduramicin and monovalent ionophores is generally considered incomplete but can occur in field isolates with reduced ionophore sensitivity; published data for specific Eimeria strain MIC distributions is limited. Unlike lasalocid, which is also approved for ruminants, maduramicin is not a cattle feed additive; its risk-benefit profile confines approved use to broiler chickens in most regions.
At the broiler feed mill, the 1.0% maduramicin premix is dispensed from a micro-ingredient dosing system, typically a loss-in-weight or auger proportioner, into the main mixer after the ground cereal base has been charged. The batch is mixed according to a qualified time established by mixer performance testing, and the finished feed is sampled at the mixer discharge using a stratified sampling thief. Retention samples are stored for the period specified by the local competent authority. In pelleting operations, recovery of maduramicin after conditioning is monitored by HPLC to confirm that the active is not thermally lost; published data for this specific configuration is limited beyond the manufacturer’s stability data. The API and premix are stored in cool, dry, ventilated warehouses in sealed antistatic packaging, and stock rotation follows first-expiry-first-out. This product is a starting material for further processing, not a direct-to-animal dosage form.
