| HS Code | 949940 |
| Chemical Name | Lasalocid A |
| Cas Number | 25999-31-9 |
| Molecular Formula | C34H54O8 |
| Molecular Weight | 590.79 g/mol |
| Physical Form | White to off-white crystalline powder |
| Solubility | Soluble in ethanol, acetone, chloroform; practically insoluble in water |
| Melting Point | 190-195°C |
| Purity | ≥95% (Veterinary Grade) |
| Storage Conditions | Store in a cool, dry place, protected from light and moisture |
| Shelf Life | 24 months under recommended storage conditions |
| Therapeutic Category | Anticoccidial and antimicrobial ionophore |
| Compatible Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
As an accredited Lasalocid 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 | Lasalocid Veterinary Grade API is packed in sealed, moisture-proof, light-resistant drums with tamper-evident closures, available in 25 kg quantities. |
| Container Loading (20′ FCL) | 20′ FCL loading: drummed, palletized Lasalocid veterinary API secured, labeled, and containerized for safe transport. |
| Shipping | Shipping of Lasalocid Veterinary Grade API is conducted in sealed, moisture-proof drums or bags meeting international safety standards. Shipments require proper hazmat classification, temperature-controlled conditions, and complete regulatory documentation. We use validated logistics partners ensuring secure, traceable delivery worldwide, protected from contamination and environmental damage. |
| Storage | Store Lasalocid Veterinary Grade API in a tightly sealed original container, in a cool, dry, well-ventilated area below 25°C. Protect from light, moisture, and heat. Keep away from oxidizing agents, food, and animal feed. Ensure good housekeeping to prevent dust accumulation. Use appropriate containment measures during handling. |
| Shelf Life | Shelf life is 24 months when stored in original tightly sealed containers, protected from light, moisture, and temperatures below 25°C. |
Broiler integrators using lasalocid sodium in starter and grower rations routinely encounter carryover-driven batch rejection when changeover protocols do not account for ionophore retention in elevator legs, dust filters, and ribbon mixer clearances. The United States regulatory anchor is 21 CFR 558.311, which sets lasalocid sodium in broiler chicken feed at 68–113 g/t of complete feed; within the European Union, the corresponding feed additive authorization under Regulation (EC) No 1831/2003 permits lasalocid sodium from approved sources in feed for chickens for fattening at 75–125 mg/kg complete feed, with residue management aligned to Commission Regulation (EU) No 37/2010 where export MRL compliance is required. A typical 15% lasalocid sodium premix is metered into the complete feed line at 0.45–0.75 kg/t to produce the label-active concentration. Starter crumble formulations generally carry 90–113 g/t active, while finisher rations may be reduced to 68–90 g/t inside the approved band; the reduction is driven by measured daily feed intake and the need to maintain coccidiosis suppression through peak oocyst shedding at 3–5 weeks of age.
| Regulatory reference | Species category | Dosage or inclusion anchor |
|---|---|---|
| 21 CFR 558.311 | Broiler chickens | 68–113 g/t complete feed |
| Regulation (EC) No 1831/2003 | Chickens for fattening | 75–125 mg/kg complete feed |
| 21 CFR 558.311 | Cattle | 1 mg/kg BW/day up to 200 mg/head/day |
| Regulation (EC) No 1831/2003 | Turkeys for fattening | 90–125 mg/kg complete feed |
In production, the lasalocid sodium premix is first pre-blended with 10–20 kg of ground corn or soybean meal for 3–5 minutes in a separate pre-blend drum, then transferred to a double-ribbon main mixer. The main mixer is operated at 20–25 rpm for 6–10 minutes after premix introduction; a coefficient of variation for lasalocid sodium assay must remain below 5% when sampled at 8–10 points per batch according to ISO 6497. Pelleting of broiler feed at 75–85°C conditioning temperature and 20–30 s retention does not typically degrade the ionophore, but post-pellet cooler exhaust air must be filtered to prevent dust carryover into adjacent unmedicated lines. Pellet die openings are 2.5–4.0 mm for starter and grower crumbles. The resulting terminal product types are broiler starter, grower, and finisher complete feeds, crumbles, and pellets. Medicated feed mills must run a flushing batch of unmedicated feed after lasalocid-containing batches before producing feed for horses or other equines; ionophore carryover into equine rations is a recognized lethal hazard. Simultaneous use with tiamulin in poultry rations is avoided because the documented metabolic interaction with polyether ionophores can lead to toxic accumulation.
In turkey grower rations, the pellet durability requirement narrows the operational conditioning window because higher mash temperatures are needed to gelatinize starch in high-density feeds, while the lipid-rich formulation reduces free moisture required for steam heat transfer. Lasalocid sodium use in turkeys for fattening is authorized in the European Union at 90–125 mg/kg complete feed under Regulation (EC) No 1831/2003; in jurisdictions following 21 CFR 558.311, turkey feed inclusion may be assigned within the 68–113 g/t band, but the specific registration must be confirmed before export. Feed business operators handling medicated turkey rations fall under Regulation (EC) No 183/2005 hygiene requirements, and premix suppliers are generally audited to FAMI-QS or GMP+ B2. For a 15% lasalocid sodium premix, the addition rate is approximately 0.60–0.83 kg/t when targeting 90–125 mg/kg in complete feed; for a 1% premix, the corresponding addition rate is 6.8–11.3 kg/t.
Turkey feed lines commonly operate a conditioner with 30–45 s retention, a 3.0–5.0 mm die, and a counterflow cooler with 10–15 min residence time. Assay samples are drawn post-cooler rather than pre-pelleting because moisture loss during cooling increases lasalocid sodium concentration on a dry-matter basis. The pellet mill load is held below 90% motor current to avoid slip-induced heat excursions above 90°C; published data for this specific configuration is limited. Medicated grower feed must be sequenced before unmedicated finisher withdrawal rations; the final 4–7 day withdrawal feed is unmedicated to clear residues under applicable export market MRL provisions. Terminal product forms include turkey starter crumble, grower pellet, and finisher pellet; the finisher pellet immediately before slaughter is unmedicated and labeled as withdrawal feed.
Because Eimeria bovis and Eimeria zuernii oocyst shedding in intensively managed calf units begins between 21 and 42 days of age, lasalocid sodium incorporation into milk replacer powder and starter grain requires feed-intake-driven dosing rather than a fixed tonnage inclusion. The United States regulatory provision in 21 CFR 558.311 for cattle feed specifies a continuous dosage of 1 mg/kg body weight/day up to a maximum of 200 mg/head/day; European Union feed additive authorizations also recognize lasalocid sodium as a coccidiostat for cattle under Regulation (EC) No 1831/2003. Milk replacer operations exporting calf feeds must maintain feed hygiene compliance under Regulation (EC) No 183/2005. Because reconstituted powder concentration varies from 120 g/L to 150 g/L, the batch addition rate for milk replacer powder is calculated as: calf body weight in kilograms multiplied by 1 mg/kg, divided by daily powder intake in kilograms. For a 50 kg calf consuming 600 g powder per day, the required concentration is 83 mg/kg powder; for starter grain fed at 1.5 kg/day, the complete feed concentration becomes 33 mg/kg. These calculated inclusion values must not exceed the 200 mg/head/day cap.
Manufacturing of medicated milk replacer typically follows a two-stage process: the lasalocid sodium premix is first dispersed into a portion of the fat-enriched powder or maltodextrin carrier for 5 min in a low-shear tumbler, then transferred to a horizontal paddle mixer for 10–15 min total blend time. Spray-cooled fat additions at 35–40°C reduce particle segregation; the final powder is sieved through a 500 µm screen before bagging. Assay testing uses the top-mid-bottom sampling plan of ISO 6497 and must demonstrate batch-to-batch variance below 7% relative standard deviation. Acidified milk replacers below pH 5.5 are not a validated matrix for this API; published data for this specific configuration is limited, and use should not proceed without confirmatory stability testing. Terminal product types are medicated milk replacer powder, calf starter pellet or texturized feed, and top-dress granules. None of these feeds may be offered to lactating dairy cattle producing milk for human consumption unless the specific national label explicitly permits such use; equine access to medicated calf feeds must be physically prevented because horses are highly sensitive to ionophore antibiotics.
In feedlot cattle receiving total mixed rations, lasalocid sodium is commonly delivered through a pelleted mineral top-dress or concentrate at a rate calculated from dry matter intake. Under 21 CFR 558.311, the daily dose remains 1 mg/kg body weight/day with a maximum of 200 mg/head/day; EU feed additive use follows Regulation (EC) No 1831/2003 for approved cattle coccidiostat applications. A 400 kg animal requires 400 mg/day; when the carrier is fed at 0.5 kg/head/day, the carrier concentration becomes 800 mg/kg, equivalent to 800 g/t. For a 20% lasalocid sodium premix, the batch addition to the carrier is 4 kg/t. Inclusion must be recalculated when dry matter intake changes by more than 10%, because underdosing leads to clinical coccidiosis and overdosing may approach the regulatory daily cap.
Production of these concentrates uses a vertical bug mixer or horizontal paddle mixer with a batch size not exceeding 2,000 kg; the lasalocid sodium premix is pre-blended with 5–10 kg calcium carbonate or salt before entering the mixer. The mineral matrix pH is maintained between 6.0 and 7.5; strongly acidic mineral mixtures may protonate the ionophore and reduce assay recovery, although published data for this specific configuration is limited. Blend moisture is held below 12% to prevent clumping and ionophore localization. Terminal products include pelleted cattle mineral top-dress, free-choice mineral tubs or loose mineral mixes, and feedlot supplement pellets. Open outdoor mineral feeders must be designed to exclude horses and other equines, and medicated feed must not be diverted to unapproved species.
Where a buyer in a feed-mill premix channel requests lasalocid sodium as a 15% or 20% granulated premix for further dilution, the specifications for particle size, bulk density, and dustability determine whether the API can be handled on an automated micro-dosing line without assay drift. Premix production for cross-border shipment is typically audited under FAMI-QS or GMP+ B2; the active substance itself must meet the veterinary API monograph specifications of the pharmacopoeia recognized by the importing jurisdiction, and where no harmonized monograph exists the supplier certificate of analysis covers assay by HPLC, related substances, loss on drying, and residual solvents. In a prototypical 15% lasalocid sodium premix, the formulation consists of 150 g/kg lasalocid sodium active, 10–20 g/kg food-grade mineral oil or lecithin as dust suppressant, and the balance as calcium carbonate, ground rice hulls, or wheat bran. This premix is then added to poultry complete feed at 0.5 kg/t to deliver 75 mg/kg lasalocid sodium; a 20% premix requires 0.375 kg/t for the same final concentration.
Granulation is performed with a high-shear mixer or a ring-die pellet mill without steam, using a die size of 3–5 mm; the granules are screened to 180–710 µm before packaging. Batch uniformity testing requires 10 sampling points per 5,000 kg batch and must meet a coefficient of variation below 5%. Flexible intermediate bulk containers are lined with polyethylene to prevent moisture ingress and static accumulation. Dedicated lines are recommended for ionophore premixes; if shared lines are used, a flush batch of unmedicated carrier is run and assayed for lasalocid sodium before changeover to non-ionophore products. Terminal product types are 15% and 20% granulated premixes, dust-suppressed powders, and 1% drum mixes for feed mill micro-dosing systems. All container labels carry the registered species-specific warnings, especially equine toxicity and withdrawal period statements.
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Across solid oral and liquid veterinary dosage forms, lasalocid sodium is handled as a low-dose coccidiostat and polyether ionophore active substance. The veterinary-grade API is the sodium salt of lasalocid A, identified by CAS 25999-31-9, empirical formula C34H53NaO8, and relative molecular mass 612.77. It is produced by submerged fermentation of Streptomyces lasaliensis, followed by organic-solvent extraction, crystallization, and vacuum drying. The product is supplied as a white to off-white crystalline powder. The standard commercial package is 25 kg net in a high-density polyethylene drum with double low-density polyethylene liners; trial quantities of 1 kg and 5 kg are available for formulation development. The API is intended for conversion into tablets, capsules, powders, granules, premixes, injectable solutions, and oral solutions, provided that the appropriate sterility, endotoxin, and particle-size controls are defined for the intended route. Its principal registered uses are as a coccidiostat in poultry and as an ionophore feed additive in cattle and sheep. In broiler feed, inclusion is commonly 75–125 mg/kg complete feed, but regional approvals must be confirmed before formulation development. This substance differs from some other polyether ionophores because it can complex both monovalent and divalent cations, which changes transport selectivity in biological membranes. Since the sodium salt is commonly used at low mass per dosage unit, control of particle size, blend uniformity, and cleaning validation are critical quality attributes.
Lasalocid sodium is a polyether ionophore but is not interchangeable with monensin, narasin, or salinomycin. Its lower relative molecular mass of 612.77 and different oxygenation pattern produce a more compact ion-complexing cavity. The molecule forms neutral complexes with both monovalent and divalent cations, whereas monensin is described predominantly as a monovalent ionophore. This difference affects biological target-species safety margins and may alter membrane transport behavior. In manufacturing, the relevant differences are the powder’s moisture uptake, particle attrition, and electrostatic charge relative to other ionophore sodium salts. Those differences require product-specific in-process limits rather than the direct substitution of one ionophore into a premix formula.
| Property | Lasalocid sodium | Monensin sodium | Salinomycin sodium | Narasin sodium |
|---|---|---|---|---|
| CAS Registry Number | 25999-31-9 | 22373-78-0 | 55721-31-8 | 55134-13-9 |
| Molecular formula | C34H53NaO8 | C36H61O11Na | C42H69O11Na | C43H71O11Na |
| Relative molecular mass | 612.77 | 692.85 | 772.98 | 786.97 |
| Ion selectivity | Monovalent and divalent cations | Predominantly monovalent | Predominantly monovalent | Predominantly monovalent |
| Primary formulation implication | Low drug load in solids and premixes; blend uniformity is critical | Low-dose feed premix; requires preblending to avoid segregation | Low-dose feed premix; careful moisture control during granulation | Low-dose feed premix; handling similar to salinomycin |
Sourcing decisions should not assume that a premix formula can be re-based from one ionophore to another without repeating homogeneity, recovery, and stability studies. In many regions, ionophore approvals are species-specific and include withdrawal periods that differ within the class. Therefore, the lasalocid sodium API is released against its own specification and is not a generic substitution for monensin or narasin.
In tablet and capsule development, lasalocid sodium is usually introduced as a milled or air-jet-micronized crystalline powder at a drug load below 5.0% w/w. The low drug load makes blend uniformity the primary release risk. Direct compression requires that the active powder pass through a sieve no larger than 250 µm and that 90% of the particle volume be below 150 µm; these are typical in-house limits rather than compendial standards. Gravimetric filling of lasalocid sodium as a pure powder is discouraged because the crystalline material has poor flow and can adhere to stainless steel contact surfaces. Wet granulation with lactose monohydrate, microcrystalline cellulose, and a non-acidic binder at a granulate moisture content of 2.0–4.0% w/w is therefore more commonly applied. Published data for this specific configuration is limited, but the process is consistent with standard low-dose solid oral manufacturing.
For tablets, high-shear wet granulation is used when the target tablet hardness is 50–80 N and the disintegration time is below 15 min in water at 37°C; these values are formulation-dependent. The API contributes little to compressibility because the drug load is below 5.0%. Process development should focus on excipient particle size, granule porosity, and binder type rather than altering the active substance. A non-acidic binder such as povidone or hypromellose is preferred because polyether ionophores can be susceptible to acid-catalyzed degradation at low microenvironmental pH.
In medicated feed premixes, lasalocid sodium is first blended with a carrier such as ground limestone or corncob fraction. Ribbon blenders, planetary screw mixers, and paddle mixers are used at production scale. Homogeneity is assessed by collecting ten stratified samples and calculating the relative standard deviation; a typical acceptance limit is not more than 5.0% RSD around the mean labeled concentration. The sodium salt can segregate if the carrier particle size is not controlled between 100 µm and 800 µm and if the final premix is transferred pneumatically over long distances. Segregation risk increases when the active-to-carrier particle size ratio exceeds 1:10. Under these conditions, the API can accumulate in the fine fraction, producing superpotent bottom samples and subpotent top samples during silo discharge. Re-milling of the carrier or addition of 0.5–1.0% w/w of a dust-suppressing oil is used to reduce separation. These interventions must not compromise chemical stability, because oil-coated carriers can raise local moisture retention and accelerate degradation above 30°C.
Thermal stability of lasalocid sodium is influenced by residual moisture and microenvironmental pH. Drying after wet granulation should be controlled to a product temperature not exceeding 50°C; if a fluid-bed dryer is used, the inlet air temperature should be maintained at 40–60°C, and the bed temperature should be monitored at multiple points to avoid hot spots. For oven drying, tray loading should not exceed 2.0 kg/m² to ensure uniform heat transfer. These are conservative engineering controls rather than pharmacopoeial requirements. The granulate moisture should be below 2.0% before compression or encapsulation to prevent sticking and hardness variation. The API is not highly hygroscopic, but fermentation-derived powders can contain residual inorganic salts that increase water absorption. Preconditioning of the granulation room at 20–25°C and 45–55% RH reduces batch-to-batch variation.
For injectable and solution dosage forms, lasalocid sodium requires a low-endotoxin grade with bacterial endotoxin limits set for the intended route. The free acid and sodium salt exhibit pH-dependent aqueous solubility; formulations may require cosolvents or buffer systems. Sterile filtration through 0.22 µm membranes is feasible only after the solution stability profile has been established, because the ionophore can be retained by membrane materials. Published data for this specific configuration is limited, and regional approvals must be supported by formulation-specific stability data before scale-up.
In multi-product feed mills, ionophore carryover is a critical control point because lasalocid sodium is active at low doses and species sensitivity differs. Equipment surfaces, elevator buckets, screw conveyors, and dust extraction ducting can retain residues. Cleaning validation protocols typically require that the next product contains less than 1.0% of the lowest therapeutic dose of the previous ionophore, but the exact limit depends on regional toxicological and regulatory assessment. For equipment used exclusively for ionophore premixes, dry cleaning with high-efficiency vacuum systems is preferred over water rinsing, because residual moisture can initiate clumping and reduce flowability. Aqueous cleaning can suspend the sparingly soluble powder and deposit it in dead legs and valve seats. Dedicated product-contact parts or disposable liner systems are more effective for high-potency premixes. Analytical recovery studies should use high-performance liquid chromatography with a limit of quantification no greater than 0.1 mg/kg in the final feed matrix to support carryover verification.
Stainless steel 316L is the preferred product-contact material. Lasalocid sodium is not corrosive, but chloride-containing cleaning agents should be avoided because pitting corrosion can occur on austenitic stainless steel under prolonged contact. For solid dosage facilities, containment of fine lasalocid sodium powder is required to protect operators from airborne exposure; local exhaust ventilation and dust collection filters should be validated for the specific particle size distribution of the API.
Release of the veterinary-grade API is performed according to a product-specific specification that should include assay, related substances, loss on drying, sulphated ash, residual solvents, elemental impurities, and, for injectable grades, bacterial endotoxins. Representative non-sterile release criteria include assay 95.0–102.0% on dried basis, total related substances not more than 2.0%, any unspecified individual impurity not more than 0.5%, and loss on drying not more than 2.0%. Residual solvent control should follow ICH Q3C, and elemental impurities should follow ICH Q3D. Stability evaluation should follow VICH GL3 with long-term storage at 25°C/60% RH and accelerated storage at 40°C/75% RH. The API should be stored in airtight containers protected from light at 15–25°C and relative humidity below 60%.
