Lasalocid Sodium Premi Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
- Product Name: Lasalocid Sodium Premi Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
- Factroy Site: Zhanjiang, Guangdong, China
- Price Inquiry: sales10@ascent-petrochem.com
- Manufacturer: Ascent Petrochem Holdings Co., Limited
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- Lasalocid Sodium Premi Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is typically used in formulations when target-species dosage and feed-inclusion rate and withdrawal-period restrictions must be controlled within specific ranges.
| HS Code | 556769 |
| Product Name | Lasalocid Sodium Premi Veterinary Grade API |
| Product Category | Veterinary Grade Active Pharmaceutical Ingredient |
| Chemical Name | Lasalocid sodium |
| Cas Number | 25999-20-6 |
| Molecular Formula | C34H53NaO8 |
| Molecular Weight | 612.77 g/mol |
| Therapeutic Class | Polyether ionophore antibiotic |
| Indications | Prevention and control of coccidiosis; growth promotion in cattle and poultry |
| Target Species | Cattle, poultry, sheep |
| Mechanism Of Action | Facilitates ion transport across cell membranes, disrupting osmotic balance in coccidia and susceptible bacteria |
| Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Appearance | White to off-white crystalline powder |
| Odor | Practically odorless |
| Solubility | Soluble in organic solvents; practically insoluble in water |
| Assay Or Purity | Typically ≥95% |
| Grade | Veterinary Grade |
| Storage | Store in a cool, dry place, protected from light, in tightly closed containers |
| Shelf Life | Typically 24 months when stored properly |
| Packaging | 25 kg fiber drum with double polyethylene liner or as per customer requirement |
| Safety Warnings | Handle with personal protective equipment; avoid inhalation and contact |
| Regulatory Status | Veterinary prescription or feed additive depending on region |
| Withdrawal Period | Follow local regulations; varies by species and dosage form |
As an accredited Lasalocid Sodium Premi 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 Sodium Premi Veterinary Grade packed in sealed, moisture-proof 25 kg drums with double liners for tablets, injections, capsules, powders, granules, premix, solutions. |
| Container Loading (20′ FCL) | 20′ FCL loading: Lasalocid Sodium Premi Veterinary Grade API, palletized, dry-container shipped for tablets, injections, capsules, powders, granules, premix, solutions. |
| Shipping | Lasalocid Sodium Premi Veterinary Grade API is shipped in sealed, labeled containers—bags, drums, or bottles—under dry, ambient conditions, protected from moisture, light, and contamination. Quantities for tablets, injections, capsules, powders, granules, premix, or solutions are packed to prevent leakage and comply with transport regulations. |
| Storage | Store in a cool, dry, well-ventilated area away from direct sunlight. Keep containers tightly closed and protected from moisture and light. Maintain temperature below 25°C (77°F); avoid freezing solutions unless labeled. Segregate from oxidizers, acids, and feed additives to prevent cross-contamination. Store veterinary APIs separately from human drugs. Follow USP/FDA and manufacturer labeling for premixes, powders, granules, capsules, tablets, injectables, and solutions. |
| Shelf Life | Typically 24–36 months when stored sealed, dry, away from light at controlled room temperature; confirm by dosage form and label. |
Lasalocid sodium is introduced into broiler coccidiosis control programmes through a staged premix, not through direct addition of neat API in the mixer. Dry API with a potency of 90–95% w/w is combined with a milled corn cob or calcium carbonate carrier at 1:9 to 1:99 w/w, followed by a second dilution step into a final complete feed concentration of 75–125 mg/kg. This inclusion range aligns with the feed additive conditions described in FDA 21 CFR 558.311 and Commission Regulation (EC) No 1831/2003 for zootechnical products. In production-scale feed mills, the first premix is mixed in a horizontal ribbon mixer with a fill volume of 60–70% and a coefficient of variation below 5% after 8–12 minutes; the final feed is then conditioned in a double-shaft conditioner at 70–85°C with a residence time of 15–30 seconds before pelleting through a ring-die pellet mill. Prolonged steam exposure above 85°C or retention beyond 45 seconds is not recommended because heat-mediated migration of the ionophore within the carrier can shift assay results at the pellet surface. Terminal finished product types are broiler starter crumbles, grower pellets and finisher pellets; each lot is sampled post-pelleting for assay and mixer uniformity before release.
What limits the formulation of lasalocid sodium as a true drinking water solution in poultry houses?
Lasalocid sodium does not spontaneously form a stable true solution in farm drinking water at neutral pH; published data for this specific configuration is limited, and industrial practice relies on a concentrated oral suspension or a co-solvent liquid intermediate. The API is practically insoluble in water at pH 6.5–8.0, so a concentrated vehicle containing propylene glycol and ethanol is required to achieve an intermediate strength of 5–10% w/v. The farm-side dosing concentration is calculated from a target intake of 0.5–1.0 mg/kg bodyweight/day, with a proportional dosing pump delivering 1:100 to 1:200 dilution into the drinking line. The production process for the intermediate liquid uses a high-shear rotor-stator mixer at 3,000–5,000 rpm for 20–30 minutes to reduce the dispersed API to D90 20 µm, followed by pH adjustment to 4.0–5.0 with citric acid and addition of 0.3–0.5% w/v suspending agent to control sedimentation. Residual solvent limits for the non-aqueous fraction are assessed under ICH Q3C, and veterinary liquid product release is controlled under EU Regulation 2019/6. Terminal product types include concentrated oral liquids for proportional dosing systems and medicated stock solutions for pullet and replacement layer flocks; continuous recirculation or agitation is required to avoid stratification in the reservoir.
| Dosage form | Established downstream sector | Technical feasibility | Typical inclusion ratio | Key process boundary |
|---|---|---|---|---|
| Feed premix / granules | Broiler, turkey, sheep, game birds | Established industrial route | 75–125 mg/kg final feed | Staged dilution required below 5% mixer CV |
| Oral suspension / drench | Calves, zoo-ungulates | Compounded or licensed liquid | 0.5–1.0 mg/kg BW/day | D90 25 µm to prevent settling |
| Drinking water concentrate | Pullets, replacement layers | Limited aqueous solubility | 5–10% w/v concentrate | pH 4.0–5.0 and continuous mixing |
| Tablets / capsules | Specialist veterinary compounding | Published data for this specific configuration is limited | Not established for industrial use | Ionophore narrow therapeutic margin |
| Injection | None validated | Not an accepted veterinary dosage form | Not applicable | Local tissue reaction and overdose risk |
Medicated oral suspensions for calves require a preserved aqueous vehicle because the target coccidial species, Eimeria zuernii and Eimeria bovis, are located in the lower gastrointestinal tract and dose precision is more relevant than in feed. The target oral dose is 0.5–1.0 mg/kg bodyweight/day for 5–7 days, translated into a suspension strength of 2.5% w/v lasalocid sodium. The downstream preparation uses a colloid mill after a pre-mix of API with 0.3–0.5% w/v xanthan gum and microcrystalline cellulose; particle size is reduced to D90 25 µm, and viscosity is controlled at 300–800 mPa·s at 25°C to balance pourability and sedimentation rate. Filling is performed on peristaltic or piston fillers into HDPE bottles with child-resistant closures and a target headspace below 10%. Compliance for the finished oral liquid follows Good Manufacturing Practice under 21 CFR 210/211 and the veterinary medicinal product development requirements of EU Regulation 2019/6. Terminal product types are single-dose oral drenches and multi-dose calf dosing bottles; batch records include viscosity, particle size and potency after re-dispersion testing.
When turkey poults are placed in floor pens, the feed premix must account for a different meal texture and higher protein binding
Turkey starter rations use a higher crude protein, commonly above 26%, and a lower metabolisable energy density than broiler rations, which changes carrier adhesion and final premix flowability. Lasalocid sodium is included in the complete turkey starter feed at 75–125 mg/kg, but the intermediate premix is prepared with a coarser ground corn cob carrier to avoid segregation during high-speed conveying. The production line operates with a mixer coefficient of variation below 5% after 10–12 minutes; the conditioned mash is pelleted through a ring-die pellet mill at 72–80°C, and the finished pellet diameter is maintained between 2.0 mm and 3.5 mm to suit poult beak size. Coccidial challenge in turkeys is driven by Eimeria meleagrimitis and Eimeria adenoeides; the medicated starter feed is offered for the first 6–8 weeks of placement. Compliance references are FDA 21 CFR 558.311 and the additive authorisation data required by Regulation (EC) No 1831/2003. Terminal product types include turkey starter pellets and, where the mill lacks pelleting capability, a coarse mash with the same inclusion rate.
Lamb creep feed has a narrower inclusion window than poultry feed because intake relative to bodyweight changes rapidly during the pre-weaning period. The target daily dose is 0.5–1.0 mg/kg bodyweight/day; when lambs consume 2–4% of bodyweight as dry matter, this corresponds to a complete feed concentration of 20–50 mg/kg. The API is first diluted into a 1% intermediate premix using ground limestone or wheat middlings, then incorporated into the final lamb creep feed with a ribbon mixer for a batch cycle of 10 minutes. Coccidial control targets Eimeria ovinoidalis and Eimeria crandallis in intensive lambing operations. The finished feed is typically pelleted at 2–5 mm to reduce sorting, and compliance is based on FDA 21 CFR 558.311 where available and the feed additive authorisation framework under Regulation (EC) No 1831/2003. Terminal product types are pelleted lamb creep feed and medicated lamb starter concentrates.
Game bird starter mash and micro-dose premix handling
Game bird coccidiosis control in pheasant, chukar partridge and quail starter feeds uses lasalocid sodium at final feed concentrations of 75–125 mg/kg, but the manufacturing line is often a small-volume batch operation rather than a continuous high-throughput feed mill. The premix is prepared at 1:9 w/w with a dust-controlled corn cob or wheat middling carrier and added through a micro-dose ingredient station at 0.05–0.5% of total batch weight; batch mixing in a double-ribbon mixer proceeds for 10–15 minutes, with a coefficient of variation below 5%. Because starter feeds for game birds are commonly fed as mash rather than pellets, particle-size overlap between carrier and final feed is controlled to prevent sifting in vertical screw conveyors. The relevant standard for the US market remains FDA 21 CFR 558.311, while EU market access is governed by the zootechnical additive dossier under Regulation (EC) No 1831/2003. Terminal products are game bird starter mash and crumble feed; production records include retained samples for assay and a withdrawal period check before the birds enter the food chain.
Competitive Lasalocid Sodium Premi Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
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- Lasalocid Sodium Premi Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is manufactured under an ISO 9001 quality system and complies with relevant regulatory requirements.
- COA, SDS/MSDS, and related certificates are available upon request. For certificate requests or inquiries, contact: sales10@ascent-petrochem.com.
A production-grade Lasalocid Sodium Premi Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a polyether carboxylic ionophore derived from fermentation of Streptomyces lasaliensis. The material is supplied as a white to off-white crystalline powder with molecular formula C34H53NaO8, CAS 25999-31-9, and relative molecular mass 612.77 g/mol. The Premi designation is a manufacturer-specific grade identifier used to separate the high-potency veterinary active pharmaceutical ingredient from carrier-diluted feed premixes, crude fermentation concentrates, and commodity coccidiostat powders. The grade is released against a certificate of analysis that includes identity, chromatographic assay, related-substance profile, residual solvents, elemental impurities, loss on drying, residue on ignition, and microbial enumeration. Its intended conversion routes are tablets, injections, capsules, powders, granules, premixes, and solutions, each of which imposes different particle-size, moisture, vehicle, and potency constraints.
What Release Limits and Monograph Methods Define the Veterinary Grade?
The veterinary API is controlled by a system of pharmacopoeial and regionally harmonized methods. Batch release includes the following profile as a representative specification for oral and feed-administered dosage forms.
| Parameter | Method/Standard | Release Limit |
|---|---|---|
| Appearance | Visual inspection | White to off-white powder, free from visible foreign matter |
| Identification | HPLC retention time; infrared absorption | Corresponds to reference standard |
| Assay on dried basis | HPLC | 95.0–102.0% |
| Loss on drying | USP 731 | ≤5.0%, 60°C vacuum 3 h |
| Residue on ignition | USP 281 | ≤1.0% |
| Elemental impurities | USP 232/233, ICH Q3D | As, Cd, Hg, Pb, Co, V, Ni meet oral or parenteral permitted daily exposure |
| Residual solvents | USP 467 | Class 3 solvents ≤0.5%; Class 1 and Class 2 below monograph limits |
| Microbial enumeration | USP 61/62 | Total aerobic count ≤100 CFU/g; E. coli and Salmonella absent |
| Bacterial endotoxins, if injectable | USP 85 | ≤0.50 EU/mg |
Related substances are monitored by HPLC peak purity, with total impurities held at ≤2.0% and single impurity at ≤1.0%. The sodium salt is sufficiently hygroscopic to require closed handling in high-humidity environments. Moisture gain above 5.0% reduces flow and can cause tablet sticking on rotary presses or capsule slugging during long compression runs.
Across solid-dose conversion lines, particle-size distribution is the principal variable affecting blend uniformity and downstream content uniformity. Direct compression grades are milled to a Dv50 between 45 µm and 75 µm and a Dv90 below 150 µm, measured by laser diffraction per ISO 13320. Fines below 10 µm are controlled to less than 12% to reduce dust formation, punch filming, and electrostatic segregation. Granulation grades are coarser, with Dv90 up to 250 µm, because the granulation step homogenizes particle-size distribution and minimizes segregation. Premix production adsorbs the milled ionophore onto maize cob, rice hull, or calcium carbonate to a target potency of 150 g/kg or 200 g/kg; mineral oil is applied before blending to suppress dust and electrostatic charging. Bulk density per USP 616 typically falls between 0.35 g/mL and 0.55 g/mL, which is adequate for drum filling and volumetric feed-metering equipment.
Thermal, Humidity, and Excipient Compatibility Boundaries in Multi-Dose Processing
Accelerated stability screening at 40°C/75% RH for 6 months is used to qualify primary packaging. Assay loss in double polyethylene-lined fibre drums with desiccant is typically below 1.5% under these conditions. The crystalline sodium salt tolerates short-term thermal exposure up to 80°C during drying; sustained heating above 100°C should be avoided because of lactone ring opening and free-acid formation. Wet granulation is acceptable when the binder is neutral or mildly alkaline. Acidic excipients such as citric acid, ascorbic acid, or certain enteric polymers should not be used, because protonation converts lasalocid sodium to the free acid and reduces aqueous dispersibility. Divalent cations in mineral premixes can compete for ionophore binding; calcium carbonate and magnesium oxide are screened for free-cation release by aqueous slurry pH and conductivity measurement before final premix formulation. Pre-drying at 60°C under vacuum for 3 h is required when Karl Fischer moisture exceeds 5.0%.
Orally administered lasalocid sodium is incorporated into complete feed at concentrations established in FDA 21 CFR 558.311 and corresponding regional monographs. In broiler chickens, anticoccidial activity against Eimeria tenella, Eimeria acervulina, and Eimeria maxima is obtained at 75–125 mg/kg complete feed. In cattle and sheep, the sodium salt is used for coccidiosis control at body-weight-adjusted feed intakes; the wider cation-binding profile permits use in ruminant diets where mineral supplementation is high. Feed stability is maintained by uniform carrier adsorption and avoidance of free-water addition. Pelleted feed exposure to 80–85°C for 15–30 s does not produce assay loss above 2.0% when the premix is pre-diluted before pelleting. Batch-to-batch variance in premix potency is controlled by ribbon-blender mixing time and by assay of the first 5 kg and last 5 kg of the discharged batch.
When Lasalocid Sodium Is Selected Over Monensin for Coccidiosis Control
Selection between lasalocid sodium and monensin sodium is based on ion selectivity and species safety margin. Lasalocid forms neutral complexes with monovalent and divalent cations — K+, Na+, Ca2+, and Mg2+ — whereas monensin is predominantly selective for monovalent K+ and Na+. This broader complexation gives lasalocid a different acute toxicity profile: equine oral LD50 values of 21.5 mg/kg for lasalocid and 2–3 mg/kg for monensin are reported in veterinary toxicology literature. Equine exposure remains contraindicated, but the numerical margin is larger for lasalocid. In poultry, lasalocid sodium is active at 75–125 mg/kg complete feed, whereas monensin sodium is typically used at 100–125 mg/kg; the active-ingredient load per tonne of feed is therefore lower at the lower end of the lasalocid range. Lasalocid also differs from salinomycin in its divalent-cation affinity and from narasin in regulatory animal-species labels; published data for salinomycin equine toxicity is limited.
For tablet and capsule conversion, direct compression is preferred when the chosen filler is neutral and when final blend moisture is below 5.0%. A typical tablet blend contains the milled API, microcrystalline cellulose, pregelatinised starch, and 1–2% magnesium stearate; colloidal silicon dioxide at 0.5–1.0% is added to improve flow. Dry granulation by roller compaction is used when bulk-density variation exceeds 10% between API lots. The slugging or roller compaction step reduces segregation and improves tablet hardness without exposing the API to water. Capsule filling is performed on dosator or tamping-pin machines; fill weight is adjusted by granule bulk density rather than API particle size alone. Blend uniformity is tested per USP 905, with acceptance values below 15 at validation scale.
Why Are Non-Aqueous Vehicles Required for Injectable Dosage Forms?
Lasalocid sodium is practically insoluble in water; solubility in pH 7.4 phosphate buffer is below 0.1 mg/mL. Injectable solutions therefore require non-aqueous or co-solvent vehicles such as propylene glycol, glycofurol, benzyl alcohol, or mixtures of these. Water addition without a suitable co-solvent causes immediate precipitation and particle growth above 10 µm, which fails the particulate-matter limits of USP 788. Formulation development reports indicate that the sodium salt is compatible with alcoholic vehicles but incompatible with acidic pH adjustment, because free-acid lasalocid has even lower solubility. Filtration of the non-aqueous solution through 0.22 µm polyvinylidene fluoride membranes is recommended before filling; adsorption losses onto nylon membranes are observed in laboratory-scale trials.
Oral solutions and drench formulations are prepared as non-aqueous concentrates or solubilized dispersions using polysorbate 80 and propylene glycol. The concentrate is diluted into drinking water only after a stable dispersion is confirmed; aqueous dilution without surfactant produces rapid sedimentation and uneven dose delivery. For powders and granules, the API is dry-blended or adsorbed onto a carrier and packed in aluminium-lined bags to maintain moisture below 5.0%. Granule size for oral administration in calves and lambs is typically 250–850 µm to allow mixing with milk replacer without floating or settling. Each dosage form requires separate validation of dose recovery and stability, because the ionophore behaves differently with vehicle polarity and mineral content.
