| HS Code | 840194 |
| Product Name | Neomycin Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Chemical Substance | Neomycin sulfate |
| Molecular Formula | C23H46N6O13 · xH2SO4 |
| Molecular Weight | 614.64 g/mol (neomycin base) |
| Cas Number | 1405-10-3 |
| Appearance | White to pale yellow powder |
| Solubility | Freely soluble in water; slightly soluble in alcohol; insoluble in acetone and ether |
| Ph Value | 5.0 to 7.5 (1% w/v aqueous solution) |
| Storage Conditions | Store in a cool, dry place, protected from light and moisture |
| Shelf Life | 24 months when stored as directed |
| Veterinary Indications | Treatment and prevention of bacterial infections caused by neomycin-susceptible organisms |
As an accredited Neomycin 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 | Packed in sealed, moisture-proof 25 kg drums, with inner polyethylene lining to protect the veterinary-grade neomycin premix API. |
| Container Loading (20′ FCL) | 20′ FCL loading: palletized, secured drums/cartons of Neomycin Premix Veterinary Grade API, with proper labeling and moisture protection for safe transport. |
| Shipping | Ship via temperature-controlled, sealed drums or bags, protected from moisture and light. Ensure compliance with international veterinary API transport regulations. Use dedicated cargo with proper labeling and documentation. Avoid extreme temperatures and contamination. Palletize securely for air, sea, or road freight, with tamper-evident seals and complete material safety data sheets. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature, ideally below 25°C. Keep in tightly sealed, light-resistant original containers, protected from moisture, direct sunlight, and excessive heat. Avoid exposure to strong oxidizers. Ensure veterinary premises maintain proper labeling and segregation. Use first-expiry-first-out stock rotation to preserve potency and stability throughout shelf life. |
| Shelf Life | Shelf life: 24 months from manufacture when stored unopened in a cool, dry place, protected from light and moisture. |
Manufacture of neomycin sulfate medicated feed premix for enteric Escherichia coli and Salmonella indications in swine and cattle is regulated as a medicated feed operation, not as a pharmaceutical dosage form. The critical process variable is not chemical degradation but particle-size-driven segregation. Neomycin sulfate API batches with bulk density 0.55–0.70 g/cm³ and a particle-size distribution in which 90% of the mass is below 150 µm can segregate against ground corn cob carriers above 1,000 µm during transfer into bulk silos; because the density difference between API and carrier can exceed 0.30 g/cm³, blend uniformity is sampled to reject lots with relative standard deviation above 5.0%. A 20% w/w neomycin base premix prepared from neomycin sulfate requires correction of the crude salt input by lot potency. At a potency of 600 µg/mg, the neomycin sulfate input is 333.3 g per 1 kg of premix; if the lot assays at 650 µg/mg, the input falls to 307.7 g/kg. The premix is produced by geometric dilution in a twin-ribbon blender with an effective working volume of 1,000 L; the final mixing time after addition of the last component is 12–15 min at 15–20 rpm. Compliance is maintained under 21 CFR Part 225 and the veterinary feed directive provisions of 21 CFR Part 558; batch release requires a stability-indicating HPLC assay for neomycin B and neomycin C per USP <621>. Terminal finished product types include 25 kg multi-wall paper bags with an inner polyethylene liner, 50 lb bags for Type B intermediates, and Type C meal or pelleted feed for on-farm administration. If the Type C feed is pelleted, post-conditioning assay is mandatory because steam injection during pelleting can redistribute water-soluble neomycin sulfate onto the pellet surface, altering recovery in the fines fraction. Do not blend neomycin sulfate premix with ionophore anticoccidials such as monensin or salinomycin unless a veterinary feed directive expressly authorizes simultaneous use; published interaction data for this specific feed configuration is limited, and both drug classes affect ion flux across biological membranes.
Neomycin sulfate water-soluble powder for drinking water administration in poultry and swine is formulated as a dry blend; its principal stability threat is moisture uptake rather than oxidation. Neomycin sulfate is freely water-soluble and exhibits deliquescent behaviour when the equilibrium relative humidity exceeds 60% RH; storage specifications require moisture content not to exceed 4.0%, and uncontrolled storage in tropical warehouses can exceed this limit within 72 h. Once the powder mass forms agglomerates larger than 2 mm, the reconstitution time in drinking water increases beyond the target of 10 min at 25°C, and the drinker-line concentration can fall below the intended 100 mg/L neomycin base when the label directs reconstitution to that concentration. A representative batch formula contains neomycin sulfate equivalent to 30% w/w neomycin base, anhydrous dextrose as the water-soluble carrier, 0.5% w/w colloidal silicon dioxide as a moisture scavenger and flow aid, and a moisture-barrier sachet material with foil or metallized film. Blending is performed in a twin-shell tumble blender at 60–70% vessel fill, 12 rpm, for 10–15 min after sieving the API through a 500 µm screen to disperse agglomerates. Industrial compliance is maintained under 21 CFR 211.110 for sampling and testing of in-process batches, with an HPLC assay per USP <621>, blend uniformity testing after the final blend, and USP <905> where unit-dose sachets are produced. Terminal finished product types include 100 g, 500 g, and 1 kg sachets for farm dosing, and bulk 25 kg fiber drums for repackaging. Do not exceed 40% RH during sachet filling; static charge accumulation on foil laminate at low humidity is controlled by grounding the form-fill-seal line, and compressed air used for transport must be dried to a dew point below −40°C.
Oral solutions of neomycin sulfate intended for neonatal calf and piglet enteric infections are compounded in jacketed stainless steel vessels where the order of addition determines whether the aminoglycoside remains in free solution or associates with polyanionic buffer species. In a 200 mg/mL neomycin base formula, neomycin sulfate is first dissolved in purified water at 25–30°C under a low-shear impeller; the solution is then buffered to pH 5.0–6.0. Adjustment above pH 7.0 is avoided because the multiple amino groups on neomycin B and neomycin C become deprotonated, increasing the risk of oxidative discolouration and reducing the free aminoglycoside fraction in the presence of anionic thickeners. Potassium sorbate at 0.1% w/w is added as a preservative for multi-dose HDPE bottles; if the formulation contains sodium citrate buffer, the citrate must be added slowly to avoid transient high local concentration that can form a charge-neutral neomycin-citrate complex. The solution is passed through a 0.45 µm polypropylene filter before filling into 100 mL, 250 mL, and 1 L high-density polyethylene bottles with induction-sealed closures. Release testing follows 21 CFR 211.165, with pH determination per USP <791>, assay for neomycin B and neomycin C per USP <621>, and microbial limits per USP <61> and USP <62>. The terminal finished product types are oral solutions and oral suspensions; the suspension variant is reserved for formulations containing insoluble adsorbents, which are not typical for neomycin sulfate because the API is freely soluble. The principal operational boundary is that acidified drinking water below pH 4.0 should be avoided unless validated by site-specific stability data; published data for hydrolysis kinetics of neomycin B under continuous acidifier exposure is limited.
High-dose neomycin sulfate tablets and boluses for ruminants are not produced by direct compression because neomycin sulfate exhibits poor compactability and pronounced hygroscopicity at granulation moisture above 2.5%. Tablet press operators observe sticking to upper punches and capping when the feed frame humidity exceeds 45% RH; the failure is traced to the formation of a thin hydrated layer on the API particle surface. The 500 mg neomycin base bolus is therefore prepared by roller compaction rather than wet granulation. Neomycin sulfate is blended with 18–22% w/w microcrystalline cellulose, 2% w/w croscarmellose sodium, and 0.5% w/w magnesium stearate; the blend is passed through a roller compactor at a roll pressure of 8–10 kN/cm and a gap of 1.5–2.0 mm, then milled to granules with a particle-size top cut of 1,000 µm. The granules are compressed on a rotary tablet press equipped with a precompression station; target tablet hardness is 80–120 N, and friability is required to be below 1.0%. Compliance with USP <905> for uniformity of dosage units and USP <711> for dissolution is mandatory, with dissolution testing in 900 mL of 0.01 N HCl at 37 ± 0.5°C using apparatus 2 at 50 rpm. Aqueous film coating with hydroxypropyl methylcellulose is applied at an inlet air temperature of 55–65°C to avoid core moisture accumulation. Terminal finished product types include 500 mg film-coated bolus tablets, 250 mg hard gelatin capsules filled from the same granulate for companion animal dose titrations, and 2 g large-animal boluses. Do not exceed 60% RH in the compression suite; if the granulate is held longer than 8 h before compression, it must be re-assayed for moisture because rehydration can raise tablet weight and reduce hardness.
The veterinary otic suspension combining neomycin sulfate, polymyxin B sulfate, and a corticosteroid is a polyelectrolyte system in which two cationic antibiotics compete for the surface of anionic suspending agents. A representative formulation contains neomycin sulfate at 5 mg/mL, polymyxin B sulfate at 10,000 units/mL, and hydrocortisone acetate at 10 mg/mL. The mixing order is controlled: neomycin sulfate is dissolved in the aqueous phase first, then polymyxin B sulfate is added; hydrocortisone acetate is dispersed separately in a high-shear rotor-stator mixer at 3,000–5,000 rpm with 0.2% w/w polysorbate 80 as a wetting agent. If the corticosteroid dispersion is added before the aminoglycoside solution is complete, neomycin sulfate can adsorb onto the hydrocortisone crystal surface, producing a gritty texture and reducing free neomycin recovery in the supernatant after 24 h. The suspension is thickened with a lightly cross-linked polyacrylic acid polymer, neutralized to a viscosity of 300–600 mPa·s for dropper dispensing. Compliance is maintained under USP <61> and USP <62> for nonsterile microbial limits, USP <911> for viscosity if the registered specification includes rheology, and 21 CFR 211.165 for release testing. The suspension is filled into 10 mL, 15 mL, and 30 mL low-density polyethylene dropper bottles. Terminal finished product types include otic suspensions for canine otitis externa and ophthalmic suspensions where a separate sterile monograph is registered. The operational boundary is that the formulation must not be terminally sterilized by autoclave; if a sterile ophthalmic presentation is required, the product is manufactured under aseptic conditions with a different preservative system validated for ocular tolerability.
Parenteral neomycin sulfate remains a narrow-indication veterinary dosage form because neomycin is poorly eliminated after systemic administration and carries a risk of nephrotoxicity and neuromuscular blockade. Where a sterile injectable solution is required for a specific veterinary indication, it is prepared as an aseptically filtered solution rather than a terminally autoclaved product; published data on autoclave degradation kinetics of neomycin sulfate at 121°C in multi-dose vial rubber-closure systems is limited, and terminal heat exposure is avoided as a precautionary formulation control. A representative batch formula contains neomycin sulfate equivalent to 50 mg/mL neomycin base, sodium chloride 9 mg/mL for isotonicity, and water for injection. The pH is adjusted to 6.0–6.5 with dilute sulfuric acid or sodium hydroxide. The solution is filtered through a 0.22 µm PVDF membrane under nitrogen pressure into depyrogenated Type I glass vials; filling is conducted in an ISO 14644-1:2015 Class 5 environment with a Grade B background. Release testing includes bacterial endotoxins per USP <85>, particulate matter per USP <788>, and sterility per USP <71>. In-process controls fall under 21 CFR 211.167 for sterile drug product processing. Terminal finished product types include 10 mL and 20 mL amber Type I glass vials with chlorobutyl rubber stoppers. The operational boundary is explicit: neomycin sulfate injection is not interchangeable with oral or topical neomycin products, and its use is confined to veterinary settings where renal function, hydration status, and neuromuscular integrity can be monitored. Do not combine with other aminoglycosides, neuromuscular blocking agents, or loop diuretics in the same infusion; simultaneous administration can potentiate neuromuscular blockade and ototoxicity.
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Neomycin Premix Veterinary Grade API is the dried sulfate salt of the aminoglycoside complex obtained by submerged aerobic fermentation of selected strains of Streptomyces fradiae. The material is distributed as a white to pale-yellow hygroscopic powder under CAS 1405-10-3 and is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in acetone and chloroform. The active composition is a mixture of neomycin B and neomycin C with minor fermentation-derived components including neamine; because this is a complex mixture rather than a single defined molecule, release testing combines chromatographic identity, potency assay, pH, water content, residue on ignition, related substances, residual solvents, and elemental impurities. Against the USP-NF Neomycin Sulfate monograph, potency is controlled at ≥650 µg/mg on the dried basis; the Ph. Eur. neomycin sulfate monograph expresses the corresponding release limit as ≥680 IU/mg. Loss on drying is controlled at ≤8.0%. Supplier model designations for this API typically encode the route-linked grade, such as oral premix, granulation, or injectable preparation, because the same fermentation-derived chemical entity is not automatically suitable for every veterinary dosage form.
Downstream purification after fermentation includes acidification, filtration, ion-exchange chromatography, carbon treatment, ultrafiltration, and spray drying. The sulfate salt is preferred because it yields a more tractable powder than the free base and allows reproducible potency standardization. Each batch is released with a certificate of analysis covering appearance, identification, potency, related substances, residual solvents according to ICH Q3C, elemental impurities according to ICH Q3D, loss on drying, residue on ignition, and microbial quality. For oral premixes and powders, microbiological quality is evaluated using USP ⟨61⟩ and USP ⟨62⟩ or Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13. A grade intended for injectable solution manufacture carries additional route-specific controls for endotoxin, bioburden, and particulate burden that are not automatically satisfied by oral-grade material.
The pharmacopoeial API monographs for neomycin sulfate establish chemical identity, potency, and purity, but they do not impose a universal bacterial endotoxin limit on the active substance itself. The binding endotoxin limit appears in the finished injectable product monograph and the marketing authorization. A manufacturer preparing an injectable solution must therefore set the API endotoxin specification from the maximum intended dose and the finished-product limit. If a finished injectable formulation carries an endotoxin limit of 0.5 EU/mg of neomycin, the API lot must demonstrate a compatible upstream value; an oral premix lot cannot be assumed equivalent without supporting data. Injectable manufacture further requires terminal sterilizing filtration through a 0.22 µm membrane after prefiltration through a 0.45 µm clarifier. Oral premix product is not sterile and must not be used as an injectable intermediate without a validated sterilization step.
Dry premix blending presents a segregation risk when the API particle size is not matched to the carrier. A typical premix-grade powder is controlled to a laser-diffraction D90 of ≤250 µm, with ≥95% passing through a 0.425 mm screen. Carriers are selected from calcium carbonate, lactose, dextrose, or corncob fractions having a bulk density between 0.45 g/cm³ and 0.85 g/cm³. In ribbon blender qualification, a 500 kg batch may require a working capacity of approximately 650 L to provide adequate top-to-bottom turnover. Thief sampling at 10 defined positions is used to confirm assay values within 90.0–110.0% of label claim and relative standard deviation ≤5.0%. The main process conflict is moisture. Neomycin sulfate is hygroscopic, and surface adsorption above 60% relative humidity at 25°C increases powder cohesion sufficiently to produce agglomerates that may not redisperse uniformly in the final feed. Blending suites are therefore conditioned to ≤40% RH, containers are closed immediately after sampling, and Karl Fischer titration at discharge verifies water gain below 2.0%. These controls are more stringent than those commonly applied to non-hygroscopic feed additives.
Wet granulation of neomycin sulfate is complicated by its aqueous solubility and hygroscopicity. The API can dissolve partially in aqueous binder and migrate toward the granule surface during drying, producing assay variation and friable compacts. If wet granulation is unavoidable, a hydroalcoholic granulating fluid with a water content not exceeding 30% is used for the target grade; the wet mass is passed through a 1.0 mm screen and dried at inlet air temperature below 60°C. Direct compression is used only when the API is preblended with a carrier of similar particle size and when lubricant concentration is kept at the minimum required; magnesium stearate above 0.5% can delay dissolution. Tablet content uniformity is evaluated according to USP ⟨905⟩ or Ph. Eur. 2.9.40. Capsule powders are dry blends or milled granules with the coarse retained fraction controlled to reduce segregation during automatic capsule filling. A recurring failure mode on tablet lines is punch filming caused by hygroscopic API adhering to tooling; low ambient humidity and clean punch faces are required to maintain acceptable hardness and weight variation.
| Attribute | Oral premix and powder | Tablet and capsule | Injectable solution |
|---|---|---|---|
| Particle-size release | D90 ≤250 µm; ≥95% through 0.425 mm | D90 ≤150 µm; dry-milled or granulated | Not applied after dissolution; filter compatibility critical |
| Water content | Loss on drying ≤8.0% per USP-NF | Karl Fischer ≤6.0% for direct compression | Solution assay and pH stability controls replace water limit |
| Microbial quality | USP ⟨61⟩ and ⟨62⟩ | USP ⟨61⟩ and ⟨62⟩ | Bioburden before sterilizing filtration |
| Endotoxin control | Not universal at API level | Not universal at API level | Derived from finished-product limit |
Solution dosage forms intended for oral drench, injectable, or ophthalmic use require the API to dissolve without particulate or endotoxin contamination. Neomycin sulfate is freely soluble in water; stock solutions above 100 mg/mL can be prepared, but the final pH must be selected from forced-degradation data because neomycin is susceptible to alkaline hydrolysis and prolonged light exposure. Injectable solutions are manufactured with Water for Injection and, where required, a nitrogen overlay. Terminal heat sterilization of neomycin sulfate solutions is not a default option; sterilizing filtration is commonly used unless the manufacturer has formulation-specific thermal stability data. The API is also incompatible in solution with certain beta-lactam antibiotics; admixture with benzylpenicillin or ampicillin can produce pH-dependent loss of neomycin potency during storage. Compatibility must therefore be tested according to the finished-product stability protocol rather than assumed from individual monographs.
Compared with feed-grade neomycin sulfate, the veterinary API grade is distinguished by lower total viable aerobic count, documented absence of Escherichia coli and Salmonella, and control of residual solvents according to ICH Q3C and elemental impurities according to ICH Q3D. Feed-grade material may be sold on the basis of a microbiological assay without a validated HPLC related-substances profile; it is not automatically suitable for tablet, capsule, or injectable manufacture. Compared with framycetin sulfate, which is standardized to the neomycin B component and used mainly in topical preparations, this product is the full fermentation complex. That compositional difference influences the activity profile and requires the manufacturer to track the neomycin B and neomycin C ratio as part of batch-to-batch consistency. Compared with gentamicin sulfate, neomycin has weaker clinically relevant activity against Pseudomonas aeruginosa and is poorly absorbed from the intact gastrointestinal tract. Its veterinary use is therefore concentrated in enteric, topical, intramammary, uterine, and ophthalmic applications rather than systemic therapy requiring reliable plasma concentrations.
Bulk packaging is typically double polyethylene bags inside a fibre drum or aluminium-laminated bag, with desiccant and nitrogen flush where needed. Storage is controlled at 15–25°C and low relative humidity, generally not exceeding 35%, because moisture ingress changes potency, flow, and blend uniformity. Stability studies are conducted according to VICH GL3 and zone-specific climatic conditions. The critical operational boundary is moisture: once a container is opened in an uncontrolled environment above 60% RH, the powder should be used within the shortest practical time or re-dried only if a validated drying procedure is available. Re-drying without validation is not recommended because thermal exposure can alter the related-substances profile and reduce assay value.
