| HS Code | 639470 |
| Chemical Name | Salinomycin |
| Molecular Formula | C42H70O11 |
| Molecular Weight | 751.0 g/mol |
| Cas Number | 53003-10-4 |
| Description | Polyether ionophore antibiotic used as an anticoccidial and growth promoter in poultry and livestock. |
| Physical Form | White to off-white crystalline powder |
| Solubility | Soluble in methanol, ethanol, acetone, chloroform; practically insoluble in water |
| Melting Point | ~140°C (decomposes) |
| Storage Conditions | Store in a cool, dry place away from light and moisture; keep container tightly closed |
| Veterinary Indication | Effective against coccidia (Eimeria spp.) in poultry and swine; also used as a feed additive for growth promotion |
| Dosage Forms | Available for formulation into tablets, injections, capsules, powders, granules, premix, and solutions |
| Withdrawal Period | Varies by species; typically 5 days for poultry and 21 days for swine (confirm regional regulations) |
As an accredited Salinomycin (Coxistac, Biocox) 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 | Salinomycin API: 25 kg net, packed in double polyethylene bags, then aluminum foil bag, and sealed reinforced fiber drum. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL): Salinomycin API packed in sealed drums/pallets, ~10–14 MT per container, secured for safe, dry transport. |
| Shipping | Salinomycin (Coxistac, Biocox) Veterinary Grade API is shipped in sealed, moisture-proof containers to ensure stability. Temperature-controlled transport is recommended. Shipments comply with IATA/IMDG regulations for safe handling and are properly labeled as a veterinary active ingredient, with full customs documentation for global delivery. |
| Storage | Store Salinomycin Veterinary Grade API in a tightly sealed, original container, protected from light, moisture, and heat. Keep in a cool, dry, well-ventilated area, ideally below 25°C. Avoid contact with acids or oxidizing agents. Use clean equipment to prevent contamination. This ensures stability for tablets, capsules, injections, premixes, and other formulations. |
| Shelf Life | Shelf life typically 24 months when stored in original, tightly sealed containers, protected from light, heat, and moisture. |
In commercial broiler complexes, salinomycin sodium is handled as a 12% Type A medicated article under 21 CFR 558.550, with approved inclusion in complete broiler feed of 40–60 g ton-1 (44–66 mg kg-1) and a 0-day withdrawal period for broiler chickens. The corresponding European Union authorization under Regulation (EC) No 1831/2003 permits a maximum of 70 mg kg-1 complete feed for chickens for fattening with a 1-day withdrawal period; the exact status of any specific formulation must be checked against current implementing acts because feed-additive authorisations are holder-specific and composition-specific. The dilution of the 12% Type A article to a Type C complete feed requires 0.5 kg of concentrated premix per metric ton to deliver 60 mg kg-1 active, or 0.583 kg per metric ton for the EU maximum of 70 mg kg-1. In a 2,000 kg horizontal ribbon mixer operated at 60–70% gross volume, the API premix is first pre-blended with a 1:10 ratio of carrier such as ground limestone, rice hulls, or soybean mill run, then geometrically diluted with the remaining carrier and discharged through an anti-static ground line. Mix homogeneity is validated by sampling multiple positions and assaying salinomycin according to ISO 6497 sampling plans; a coefficient of variation not exceeding 5.0% is the standard acceptance threshold on production-scale medicated feed lines. Terminal products include broiler starter, grower, and finisher pellets or crumbles, with conditioning and pelleting temperatures held below the validated stability limit of the specific formulation, commonly 85°C for short-residence conditioning. The principal manufacturing failure mode at this stage is segregation during pneumatic transfer because the API-loaded carrier can have a density and particle size different from coarse feed ingredients; this is controlled in the granulated route described below.
Feed mills that dose micro-ingredients through loss-in-weight or screw metering systems replace the dry powder premix with a granulated salinomycin sodium concentrate on a mineral or fibre carrier. Regulatory compliance remains tied to 21 CFR 225 for medicated feed manufacturing in the United States and to the EU feed hygiene rules under Regulation (EC) No 183/2005; occupational exposure control follows the API safety data sheet because no harmonised compound-specific OEL has been published. The granulation formula typically combines salinomycin sodium with a dense carrier such as calcium carbonate or kaolin, a binder such as mineral oil or lignosulfonate at 1–3% w/w, and a moisture scavenger if the carrier lot exceeds 1.0% w/w residual moisture by ISO 6496. In a fluid-bed granulator or high-shear granulator, the wet mass is agglomerated and then sieved on ISO 3310-1 screens to a target granule fraction between 150 µm and 850 µm; fines below 150 µm are recycled, and oversize is milled through a low-speed conical mill. Field experience on production-scale fluid-bed lines shows that uncontrolled fines generated during drying are the main root cause of dusting at the feed mill masterbatch hopper and of subsequent assay drift. The finished granulated premix is discharged into anti-static bulk bags and metered with a micro-dosage system at a target of 0.5–0.6 kg per metric ton of finished feed depending on the desired final active concentration. Terminal products are low-dust granular masterbatches and final pelleted rations; the granulated form sustains assay uniformity through high-speed screw conveying better than the equivalent 12% powder blend.
| Dosage route | Typical active load | Critical process parameter | Test standard | Terminal form |
|---|---|---|---|---|
| Medicated feed premix | 12% Type A; final feed 40–70 mg kg-1 | Ribbon mixer fill 60–70%; geometric dilution | ISO 6497; CV ≤ 5.0% | Type C mash, pellet, crumble |
| Granulated premix | 12% active on carrier | Binder 1–3% w/w; granule fraction 150–850 µm; moisture < 1.0% w/w | ISO 3310-1; ISO 6496 | Low-dust granular masterbatch |
| Non-aqueous oral solution | No approved food-species concentration | Solvent screen in propylene glycol, PEG 400, ethanol; filtration 5 µm or 0.45 µm | USP <795> for compounding; no feed-additive monograph | Compounded oral drench, research or non-food birds only |
| Tablet / capsule | No official dose ratio for poultry | Wet granulation or roller compaction; moisture < 1.0% w/w | 21 CFR 211; ICH Q7; ICH Q1A(R2) | Immediate-release tablets or capsules, research use |
| Injection | No licensed parenteral concentration | Aseptic filtration 0.22 µm; non-aqueous solvent system | No veterinary injectable monograph; research GMP principles | No commercial parenteral product |
The development of an oral solution or drench based on salinomycin sodium encounters a fundamental solubility boundary: the sodium salt is practically insoluble in water, therefore aqueous water medication is not a realistic formulation route without solubilizing excipients that alter the ionophore’s release and may not be covered by existing feed-additive authorisations. In the United States any non-aqueous oral preparation for a non-food captive bird or research animal would fall under USP <795> for nonsterile compounding or 21 CFR 211 if manufactured as a registered veterinary product; in the European Union no salinomycin sodium oral solution is currently authorised as a feed additive or veterinary medicinal product for food-producing species. A solvent screen would include propylene glycol, polyethylene glycol 400, and absolute ethanol, with the API dissolved at a concentration determined experimentally rather than from a pharmacopoeial monograph. Published data for this specific configuration is limited, and the absence of a stability-indicating forced-degradation data set means that each formulation must be screened for peroxide formation in polyethylene glycol grades and for light-induced degradation in amber high-density polyethylene packaging. Filtration through a 5 µm or 0.45 µm non-shedding filter is used to remove undissolved API aggregates. The terminal product, where used, is a compounded oral drench for individual animal administration in non-food avian or research protocols; no commercial food-animal solution can be claimed without a valid marketing authorisation, and treatment withdrawal periods cannot be extrapolated from feed-derived tissue depletion data.
Tablet and hard gelatin capsule dosage forms containing salinomycin sodium are not established as commercial veterinary products with a pharmacopoeial monograph; consequently, manufacturing decisions rely on API-grade data and current good manufacturing practice for finished pharmaceuticals rather than on a compendial release specification. In the United States, a registered tablet facility would follow 21 CFR 211; in the European Union, the equivalent framework is EU GMP Part I, with the salinomycin sodium raw material controlled under ICH Q7 as an active pharmaceutical ingredient. Direct compression is generally unsuitable because the API is electrostatically charged, low-density, and tends to adhere to tablet punch faces; the preferred process is alcohol-free wet granulation or roller compaction, with the API pre-blended with microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate at ratios determined by a formulation development study. No official dose ratio exists for tablet or capsule administration in food-producing poultry; individual dose calculations, where used in captive birds or in controlled research, must be derived from body weight in mg kg-1 and not from the mg kg-1 complete-feed concentration. The granulation is dried to a moisture specification below 1.0% w/w by ISO 6496, milled, and compressed on a rotary tablet press with a pre-compression stage to reduce capping; for hard capsules, the granulate is filled on a dosator or tamping-pin capsule machine. Terminal products are immediate-release tablets and capsules intended solely for non-food avian or laboratory use; published stability data for this specific configuration is limited, and a company-specific stability protocol aligned with ICH Q1A(R2) is required before release.
Injectable salinomycin sodium occupies a sharply different risk envelope from oral coccidiostat feed applications because the ionophore disrupts monovalent and divalent cation gradients across excitable membranes, producing dose-dependent skeletal muscle and cardiac effects when systemic exposure bypasses the gastrointestinal epithelial barrier. There is no authorised injectable salinomycin sodium product for cattle, swine, poultry, or companion animals in the United States under 21 CFR 522 or in the European Union under the centralised veterinary medicines framework; published data for this specific configuration is limited. If a parenteral formulation were developed for a non-food research application, the API would require a sterile lyophilized or non-aqueous solvent system, aseptic filtration through a 0.22 µm sterilizing-grade membrane, and an aqueous solubility adjustment with a co-solvent such as dimethylacetamide or polyethylene glycol 400; the risk of precipitation at the injection site would require a compatibility screen in the selected solvent vehicle. Process control would include terminal sterilization by moist heat only if the formulation demonstrated no assay loss at 121°C for 15 min, otherwise aseptic filling in an isolator. The terminal product, if any, would be confined to licensed laboratory protocols or non-food species research; no withdrawal period, tissue residue limit, or food-safety conclusion can be assigned because the kinetic behaviour after parenteral administration is not represented by existing feed-additive residue studies.
Salinomycin sodium in any finished dosage form must be segregated from tiamulin hydrogen fumarate and related pleuromutilin antibiotics during premix manufacturing, conveying, and on-farm mixing because the combination is contraindicated in poultry and can precipitate ionophore toxicosis. The incompatibility is not a simple physical deactivation; tiamulin inhibits cytochrome P450-mediated oxidation of salinomycin, allowing toxic accumulation even at feed concentrations within the approved range. Under 21 CFR 225 sequential production controls, the same mixer, drag conveyor, bucket elevator, and pelleting die used for a tiamulin medicated ration must be flushed with a suitable carrier and the flush material disposed of or reworked in a compliant manner before salinomycin is introduced. Analytical verification of flush effectiveness uses residue swabbing followed by LC-MS/MS with a limit of detection below 0.1 mg kg-1 in flush material. In addition, salinomycin premixes should not be combined with antioxidant systems containing transition-metal ions that promote peroxide formation, because oxidative degradation of the polyether ring can reduce anticoccidial activity and generate uncharacterized by-products. The terminal finished product is a salinomycin Type C feed that is assay-positive at the intended concentration, tested for cross-contamination markers, and accompanied by a mill certificate demonstrating compliance with 21 CFR 558.550 or the applicable EU implementing act. This cross-contamination control step is operationally critical on multi-product feed lines where tiamulin and salinomycin are both used at the same facility.
| Jurisdiction / framework | Legal basis | Species / use | Concentration limit | Withdrawal / control |
|---|---|---|---|---|
| United States | 21 CFR 558.550 | Broiler chickens | 40–60 g ton-1 | 0-day withdrawal |
| European Union | Regulation (EC) No 1831/2003 | Chickens for fattening | ≤ 70 mg kg-1 complete feed | 1-day withdrawal |
| Medicated feed GMP | 21 CFR 225; Regulation (EC) No 183/2005 | All medicated feed lines | Assay within approved range | Flush validation by LC-MS/MS |
| API / finished pharmaceutical GMP | ICH Q7; 21 CFR 211 | Tablet, capsule, research compounding | No official dosage form limit | Stability per ICH Q1A(R2) |
Competitive Salinomycin (Coxistac, Biocox) 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!
Salinomycin (Coxistac, Biocox) veterinary-grade API is the sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus. The CAS registry number of the sodium salt is 55721-31-8; the molecular formula is C42H69NaO11 and the relative molecular mass is 772.98 g/mol. The substance is supplied as a white to off-white crystalline powder with low aqueous solubility and high lipophilicity. Commercial models such as Coxistac 6% and 12% granulated premix and Biocox 60 and Biocox 120 are diluted, carrier-loaded presentations; they are not direct substitutes for the pure API in dose calculations. The API can be processed into tablets, capsules, powders, granules, premixes, and non-aqueous solutions where authorized. Injectable presentations are not a common food-animal dosage form because salinomycin has a narrow therapeutic index and is intended primarily for intestinal coccidiosis control.
Release of salinomycin sodium API for downstream dosage-form manufacture is controlled by the marketing authorization dossier and, where applicable, compendial monographs for veterinary drug substances. Identification is performed by infrared absorption against a qualified working standard. Potency is determined by high-performance liquid chromatography with ultraviolet or evaporative light-scattering detection and expressed on the dried basis. Related substances are measured by area-normalisation HPLC; individual and total limits are established during process validation. The table below summarises a representative release matrix used in API qualification; it is not a regulatory substitute for a product-specific specification.
| Quality attribute | Test method | Representative release range |
|---|---|---|
| Appearance | Visual inspection under D65 illumination | White to off-white crystalline powder |
| Identification A | Infrared absorption spectrophotometry | Matches salinomycin sodium reference spectrum |
| Assay, dried basis | HPLC-UV at selected wavelength | 95.0–102.0% |
| Total related substances | HPLC area normalisation | ≤ 2.0% |
| Loss on drying | Vacuum oven, 60–70 °C | ≤ 5.0% |
| Residual solvents | Static headspace GC-FID per VICH GL18 | Class 1 solvents not detected; Class 2/3 within registration limits |
| Elemental impurities | Risk assessment per ICH Q3D/VICH GL18 | As justified by component and manufacturing stream |
Residual solvent limits follow VICH GL18 for veterinary APIs; fermentation-derived salinomycin sodium may require headspace gas chromatography with flame ionisation detection for methanol, acetone, or ethyl acetate if used in downstream purification. Elemental impurities are controlled through a risk assessment under ICH Q3D principles rather than by default heavy-metal limit tests. Batch-to-batch variation in related substances can arise from fermentation minor metabolites; HPLC method validation must demonstrate resolution between salinomycin sodium and close structural polyethers.
Dry dosage-form processing requires particle-size distribution to be fixed not by API specification alone but by the intended blend ratio. For tablet and capsule manufacture, a low-dose API with d90 above 150 µm can segregate from direct-compression excipients during bin transfer; operators therefore often use a co-milled or jet-milled grade with d50 between 10 µm and 25 µm only when dry granulation or roller compaction is employed. In 12% feed premix operations, a carrier such as calcium carbonate or solvent-extracted soybean meal with particle size 150–600 µm is blended with salinomycin sodium in a ribbon mixer or paddle mixer. Blend uniformity testing after 10, 20, and 30 minutes is used to establish a process window; acceptance is typically a relative standard deviation not more than 5.0% across 10 stratified samples. Scaling from pilot-scale V-blenders to production-scale ribbon mixers requires verification because flow hydrodynamics change with fill level and impeller tip speed. Fine API dust can accumulate in baghouse filters and cause carryover if changeover procedures do not include filter blowback, hopper cleaning, and static discharge control.
Tablets and capsules are developed using low-dose blending with a two-step geometric dilution. The first pre-blend typically contains 1 part API and 9 parts lactose monohydrate or dibasic calcium phosphate dihydrate; the pre-blend is passed through a 500 µm screen before final blending. If direct compression is used, the formulation must include a glidant such as colloidal silicon dioxide at 0.5–1.0% and a lubricant such as magnesium stearate at 0.25–1.5%; extended mixing with magnesium stearate can reduce tablet tensile strength due to hydrophobic film formation. For dry granulation, slugging or roller compaction densifies the blend before compression; granule hardness and sieve fraction are monitored because overdried granules generate fine particles that segregate at the die table.
Salinomycin sodium has low aqueous solubility; direct preparation of a simple aqueous injection or oral solution is not feasible without a co-solvent system. Preformulation studies commonly screen medium-chain triglycerides, propylene glycol, benzyl alcohol, and non-ionic surfactants; the selected vehicle must maintain chemical stability at 40 °C/75% RH or 25 °C/60% RH according to VICH GL3 stability protocols. Oxidative degradation can occur under accelerated storage; antioxidant systems are evaluated only after safety assessment in the target species. Solutions intended for drinking-water administration require a stable emulsion or microemulsion because the molecule partitions poorly into water at pH 6–8. Tablet and capsule formats avoid solubility constraints but require content uniformity at low dose. Granulated premix is preferred for feed manufacturing because it reduces dust and improves flow relative to raw API powder. Published peer-reviewed preformulation data for salinomycin-specific parenteral vehicles is limited; most commercial formulations are feed-grade premixes rather than liquid parenterals.
The coccidiocidal action of salinomycin depends on its ability to shuttle potassium ions across the pellicular membranes of Eimeria sporozoites and merozoites. This mode of action differs from that of nicarbazin, a chemical complex that does not exhibit ionophoric transport, and from synthetic compounds such as toltrazuril that act at different parasite stages. Among polyether ionophores, salinomycin is classified as a monovalent ionophore with higher potassium than sodium selectivity. Monensin sodium and narasin are also monovalent but differ in sodium/potassium preference and potency. Lasalocid sodium transports divalent cations and has a different complexation geometry. These mechanistic differences influence dose, spectrum, and species sensitivity but do not eliminate cross-resistance risk in all Eimeria field strains.
| Comparative attribute | Salinomycin sodium | Monensin sodium | Lasalocid sodium | Nicarbazin |
|---|---|---|---|---|
| Chemical class | Polyether ionophore | Polyether ionophore | Polyether ionophore | Chemical complex |
| Primary cation selectivity | K+ > Na+ | Na+ > K+ | Divalent cations | Not applicable |
| Common broiler feed use | Prevention of Eimeria spp. coccidiosis | Prevention of coccidiosis; growth promotion claim varies by jurisdiction | Prevention of coccidiosis | Prevention of coccidiosis |
| Notable formulation constraint | Contraindicated with tiamulin; low aqueous solubility | High toxicity in equids; tiamulin interaction | Wider margin in cattle; divalent ion binding | Heat stress concerns in broilers under high ambient temperatures |
Efficacy evaluation for coccidiostat premix products generally follows anticoccidial sensitivity testing in broilers with lesion scoring and oocyst output reduction as primary endpoints. The 60 ppm broiler feed concentration is widely cited in regulatory documents, but regional labels may restrict maximum use or require rotation programmes with other coccidiostats. Differences in ion selectivity affect formulation compatibility with chelating minerals and high-dose trace minerals; lasalocid is more likely to complex divalent mineral cations, whereas salinomycin shows a primary interaction with monovalent cations.
Feed mill carryover is the principal production bottleneck because salinomycin is active at parts-per-million concentrations and is toxic to horses at residual levels. Dedicated production lines or validated sequencing is used; flush material is tested for ionophore residues. In a common setup, a 1,000 L paddle mixer discharging through a bucket elevator is followed by a 500 kg wheat-middling flush; residual salinomycin in the first flush batch must not exceed the carryover limit defined by regional feed-safety rules. Co-administration with tiamulin or pleuromutilin-class antibiotics is prohibited because metabolic interaction can potentiate ionophore toxicity in target species. Premix manufacturing frequently uses granulation with 2–5% mineral oil or lignosulfonate binder to reduce dust and improve flow; the granulation step must not raise moisture above the loss-on-drying limit. Tablet manufacture from raw API requires a fully validated cleaning procedure because salinomycin sodium can adhere to stainless steel and show carryover at low levels.
Granulated premix is not simply a diluted powder; it is an engineered blend with particle-size distribution, dust control, and bulk density set for metering accuracy. Feed manufacturers should verify bulk density, angle of repose, and flow through a gravimetric or volumetric screw feeder. A target coefficient of variation for feeder output below 3.0% across 30 min may be used during qualification. The premix must be mixed into complete feed in a two-stage process: first with 25–50 kg of ground corn or soybean meal as a diluent, then incorporated into the final batch. The API activity is calculated on a dried basis, and the feed concentration is expressed in milligrams of salinomycin sodium per kilogram of complete feed. Regional labels such as 21 CFR 558.550 and EU feed-additive authorisations define permitted species, minimum and maximum inclusion rates, and withdrawal periods. Users must not assume that Coxistac and Biocox presentations are interchangeable across formulations if the carrier system differs.
In the United States, salinomycin sodium as a Type A medicated article for broiler feed is referenced in 21 CFR 558.550; approved species and inclusion rates must be read from the current e-CFR because label changes occur. In Europe, salinomycin sodium is a coccidiostat feed additive under Regulation (EC) No 1831/2003; the additive is subject to maximum residue limits and withdrawal periods in relevant species. Veterinary-grade API manufactured outside the intended marketing area must be qualified against the applicable GMP framework: EU GMP Part II for active substances, ICH Q7 for GMP APIs, and 21 CFR 210/211 for finished dosage forms where applicable. Unopened API should be stored in tightly closed containers under controlled room temperature 15–25 °C unless otherwise specified and protected from light and moisture.
Analytical control of finished dosage forms relies on extraction of salinomycin from complex feed matrices followed by liquid chromatography-tandem mass spectrometry. Matrix effects from feed lipids can suppress ionisation; method validation must include matrix-matched calibration curves across the range 1–100 mg/kg and recovery checks at 10 mg/kg, 50 mg/kg, and 100 mg/kg. Acceptable recoveries are set by the analytical laboratory according to ISO 17025 or equivalent. For tablet and capsule forms, dissolution testing in 0.1 M hydrochloric acid may be used as a quality-control marker when a compendial or validated in-house method exists; published data for salinomycin-specific dissolution is limited. The final manufacturing stage must reject batches with abnormal granule hardness, moisture, or assay variability outside the validated range.
