Sulfamonomethoxine Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
- Product Name: Sulfamonomethoxine Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
- Factroy Site: Yudu County, Ganzhou, Jiangxi, China
- Price Inquiry: sales10@sinochem-nanjing.com
- Manufacturer: Ascent Petrochem Holdings Co., Limited
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- Sulfamonomethoxine Premix Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is typically used in formulations when target drug content and particle-size distribution and process temperature, relative humidity, and cross-contamination levels must be controlled within specific ranges.
| HS Code | 917959 |
| Product Name | Sulfamonomethoxine Premix Veterinary Grade API |
| Synonyms | Sulfamonomethoxine; Sulfamonomethoxin; SMM; 4-Amino-N-(6-methoxy-4-pyrimidinyl)benzenesulfonamide |
| Cas Number | 1220-83-3 |
| Molecular Formula | C11H12N4O3S |
| Molecular Weight | 280.30 g/mol |
| Appearance | White to off-white crystalline powder |
| Assay Purity | ≥98.0% veterinary grade |
| Melting Point | 204-206°C |
| Solubility | Practically insoluble in water; soluble in acetone, chloroform, and dilute alkali |
| Drug Class | Sulfonamide antibacterial |
| Mechanism Of Action | Inhibits dihydropteroate synthase in bacterial folate synthesis |
| Indications | Treatment and prevention of bacterial infections and coccidiosis in animals |
| Target Species | Poultry, swine, cattle, fish, and other veterinary species |
| Dosage Forms | Tablets, injections, capsules, powders, granules, premix, solutions |
| Grade | Veterinary grade API |
| Storage Conditions | Store in a cool, dry, well-ventilated place, protected from light and moisture |
| Shelf Life | 24 months when stored properly |
| Packaging | 25 kg fiber drum with double polyethylene inner bags, or as customized |
| Withdrawal Period | Varies by species and formulation; follow local veterinary label directions |
| Regulatory Status | Veterinary prescription only; use under professional supervision |
As an accredited Sulfamonomethoxine 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 | Supplied in 25-kg fiber drums with dual LDPE liners, sealed for veterinary-grade sulfamonomethoxine premix API, ensuring stability and contamination protection. |
| Container Loading (20′ FCL) | 20′ FCL loading: Sulfamonomethoxine Premix Veterinary Grade API securely packed in drums/pallets for tablets, injections, capsules, powders, granules, premix, solutions. |
| Shipping | Sulfamonomethoxine Premix Veterinary Grade API is shipped in sealed, moisture-proof drums or fiber containers under cool, dry conditions, away from light and contaminants. Transport follows IATA/IMDG/ADR and local veterinary pharmaceutical regulations. Each shipment includes COA, MSDS, and proper labels; handle as a non-hazardous active pharmaceutical ingredient unless otherwise classified. |
| Storage | Store Sulfamonomethoxine Premix Veterinary Grade in a tightly sealed, original container in a cool, dry, well-ventilated area, protected from light and moisture. Keep away from heat, ignition sources, and incompatible materials. Maintain between 15–25°C unless the manufacturer specifies otherwise. Segregate from feed, food, and drinking water. Follow local regulations and label instructions. Keep out of reach of children and animals. |
| Shelf Life | Sulfamonomethoxine Premix Veterinary Grade API: expected shelf life 2–3 years depending on formulation; store below 30°C, dry, protected from light. |
In high-throughput broiler drinking-water medication, the dry blending route for sulfamonomethoxine sodium is constrained by two interrelated physicochemical thresholds: particle size reduction of the API and the pH-buffering reserve of the reconstituted product. The finished soluble powder is formulated to contain 100–300 g/kg active sulfamonomethoxine, expressed as the free acid, which corresponds to 10–30% w/w; the sodium salt correction factor is taken from the certificate of analysis and is typically 1.08–1.12. The remainder is a dry carrier system of anhydrous lactose at 55–75% w/w, sodium carbonate at 5–8% w/w, and colloidal silicon dioxide at 0.5–1.0% w/w. Production begins with jet milling through a pancake mill at 7 bar compressed air to a D90 ≤ 75 µm; milling below 10 µm is not performed because electrostatic adhesion to blender walls and sieve blinding have been observed in production-scale batches. The milled API is pre-blended 1:10 with anhydrous lactose in a 1000 L twin-shell blender at 12 rpm for 15 min; the pre-blend is then passed through a 500 µm screen and final-blended for 20 min until the coefficient of variation for sulfamonomethoxine content is ≤ 5.0% as measured by HPLC according to a VICH GL1-validated method. Packaging is performed at ≤ 25°C and ≤ 30% RH; moisture content by USP <731> is limited to ≤ 1.5%. The product is sealed into 100 g and 500 g metallized polyethylene/PET sachets with seal peel strength tested under ASTM F88-21 to no less than 3.5 N/15 mm. Reconstitution into drinking water at pH 8.2–9.5 is required; water hardness above 250 ppm CaCO₃ leads to precipitation of calcium sulfonamide species, so water treatment or higher buffer reserve is required. Residue control in poultry is governed by Commission Regulation (EU) No 37/2010, which assigns sulfonamides a combined MRL of 100 µg/kg in muscle, fat, liver and kidney; withdrawal periods must be assigned under EU Regulation 2019/6. Terminal finished product types are water-soluble sachet formulations intended for in-line dosing pump or tank medication.
What Changes When Sulfamonomethoxine Sodium Is Converted to a Sterile Injectable?
Injectable manufacturing shifts the primary control point from blend uniformity to dissolved oxygen, pH, and bioburden. The formulation target is 100–200 mg/mL sulfamonomethoxine expressed as active base, corresponding to 10–20% w/v, using sulfamonomethoxine sodium hydrate corrected for salt/base equivalence per the API certificate of analysis. Compounding is performed in a closed stainless-steel vessel at 30–40°C with a nitrogen overlay sufficient to maintain dissolved oxygen below 500 ppb; the pH is raised to 9.0–10.5 with 1 M sodium hydroxide and held for 30 min before filtration. Solutions are passed through a 0.45 µm polypropylene prefilter and then a 0.22 µm hydrophilic PVDF sterilizing filter with integrity testing performed pre-use and post-use according to EU GMP Annex 1. Aseptic filling occurs in an ISO 14644-1 Class 5 environment with Grade A laminar airflow; terminal steam sterilization at 121°C with F₀ ≥ 8 is applied only where forced-degradation data confirm total related substances ≤ 2.0%. The container is amber Type I glass with chlorobutyl stoppers in 50 mL and 100 mL formats. Release tests include sterility per Ph. Eur. 2.6.1, bacterial endotoxins per Ph. Eur. 2.6.14, subvisible particulate matter per Ph. Eur. 2.9.19, and assay by HPLC. The operational boundary is narrow: at pH below 8.5 the free acid precipitates; contact with calcium- or magnesium-containing diluents produces needle-like crystals; and the solution is incompatible with lactated Ringer's injection. For food-producing cattle and swine, residue compliance follows Commission Regulation (EU) No 37/2010. The terminal finished products are single-dose and multidose injectable solutions for swine, cattle, and sheep where regional marketing authorisation exists.
Feed Premix Dilution Geometry, Dusting Thresholds and Carryover Control
Geometrically, feed premix production is a dilution problem rather than a dissolution problem: the active must be recoverable at a uniform concentration after 1:1000 or 1:4000 final feed dilution. Premixes are compounded at 100 g/kg or 200 g/kg sulfamonomethoxine, corresponding to 10% or 20% w/w, onto a low-moisture carrier of calcium carbonate and rice hulls, with pharmaceutical-grade mineral oil at 0.5–1.5% w/w added as a dust suppressant. The mixing operation uses a horizontal paddle mixer filled to 60–70% working volume; a preliminary 1:10 active-to-carrier pre-blend is dispersed for 10 min, then transferred to the main mixer for 15 min at 20–25 rpm. A tracer validated during process qualification must show a coefficient of variation ≤ 5.0% across 10 sampling points. In-process control includes bulk density and tapped density per Ph. Eur. 2.9.34, loss on drying ≤ 2.0%, and sieve retention through 500 µm ≥ 95%. Carryover control follows EU Regulation 2019/4 Annex II, with flushing sequences and validated acceptance criteria established for equipment train cleaning; medicated feed production is also subject to HACCP under Regulation EC No 183/2005 and, in the United States, 21 CFR Part 225. Final complete feed containing 50–200 mg/kg active is region-specific and must be justified by the authorised species-specific withdrawal period established under EU Regulation 2019/6. The terminal premix pack is a 20 kg paper/polyethylene bag or bulk bag for incorporation in vertical or horizontal feed mixers.
Because calf boluses disintegrate in a low-fluid rumen environment, the formulation of sulfamonomethoxine into an immediate-release oral tablet is governed by the hardness-friability conflict rather than by dissolution rate alone. The tablet matrix is compounded at 400–600 mg sulfamonomethoxine per unit, equivalent to 40–60% w/w for a 1000 mg tablet weight; microcrystalline cellulose at 20–30% w/w acts as the compression substrate, croscarmellose sodium at 2–5% w/w as the disintegrant, povidone K30 at 2–4% w/w as the binder, and magnesium stearate at 0.5–1.0% w/w as the lubricant. Granulation is performed in a high-shear granulator with purified water or a 5% w/w povidone solution at a spray rate adjusted to maintain wet mass endpoint; the dried granulate is milled through a 1000 µm screen and compressed on a 16-station rotary tablet press at 12–20 kN. Target hardness is 80–130 N, friability is ≤ 1.0% per USP <1216>, disintegration is ≤ 15 min per USP <701>, and mass uniformity meets Ph. Eur. 2.9.5. The process window narrows when magnesium stearate exceeds 1.5% w/w, because hydrophobic films delay water penetration, and when ambient relative humidity exceeds 55% RH, because sticking and picking on the die table increase. For food-producing calves, residue compliance follows Commission Regulation (EU) No 37/2010, and withdrawal periods are established under EU Regulation 2019/6. Terminal product types are 500 mg and 1000 mg immediate-release oral tablets packed in PVC/PVdC blisters; the dosage form is suitable only where regional marketing authorisation covers the target calf indication.
Moisture-Induced Granulation Failure Occurs Below 1.5% Loss on Drying
Granulation water volume, not API content, controls the porosity and disintegration behavior of porcine oral granules, because over-wetting produces dense agglomerates that resist disintegration, while over-drying generates friable fines. The dry blend is composed of sulfamonomethoxine at 10–20% w/w (100–200 mg/g), lactose monohydrate at 60–75% w/w, povidone K30 at 3–5% w/w, crospovidone at 2–4% w/w, and sodium citrate dihydrate at 1–2% w/w. Purified water is sprayed at 8–12% w/w of dry mass in a 600 L high-shear granulator; the endpoint torque is maintained at 18–25 N·m, and the wet mass is passed through a 16 mesh screen. Fluid-bed drying uses inlet air at 60–70°C while product temperature is held at 40–45°C; final loss on drying per Ph. Eur. 2.2.32 is 1.5–2.5%, and the sieve fraction between 16 mesh and 40 mesh should contain not less than 90% of the batch. Drying above 50°C product temperature causes API-related yellowing, and LOD below 1.5% increases brittle fracture during conveying. Stability samples are placed at 25°C/60% RH and 40°C/75% RH according to VICH GL3; assay and related substances are determined by HPLC using a VICH GL1-validated method; residual water is controlled by Ph. Eur. 2.2.32. Terminal finished forms are 100 g and 500 g high-density polyethylene containers with child-resistant closures, reconstituted by the end user to a 100 mg/mL oral suspension or top-dressed onto feed. Published data for torque endpoint correlations in sulfamonomethoxine granulation is limited, so validation batches must begin with conservative water volumes and use retained granule morphology as the release criterion.
When Liquid Dose Proportioners Demand Preserved Aqueous Concentrates
Variable water pressures and intermittent flush cycles in liquid dose proportioners impose two simultaneous requirements on aqueous sulfamonomethoxine concentrates: physical stability across dilution volumes and microbial control during in-use storage. The concentrate is formulated at 100 g/L sulfamonomethoxine as sodium salt, equivalent to 10% w/v active base, in purified water adjusted to pH 9.0–10.0 with 1 M sodium hydroxide. The preservative addition ratio is not fixed; a challenge test under Ph. Eur. 5.1.3 determines the minimal effective concentration, typically not exceeding 0.2% w/v of the selected preservative blend, and the final specification includes preservative assay and efficacy. Compounding uses a vacuum-rated stainless-steel vessel at 20–30°C; the solution is circulated for 30 min and polished through a 10 µm polypropylene filter before filling into 1 L and 5 L high-density polyethylene containers with dosing-pump closures. In-use chemical stability is confirmed under repeated withdrawal and topping-up over 7 days; ultraviolet exposure is controlled because sulfonamide solutions degrade under light, requiring opaque or amber packaging. The finished product types are concentrated oral solutions for proportioner-mediated drinking-water medication in pigs and poultry; hard water above 250 ppm CaCO₃ may depress solubility at the point of dilution, and prolonged storage above 25°C accelerates pH drift. Compliance includes VICH GL3 stability protocols and Ph. Eur. 5.1.3 for preservative efficacy; residue control for food-producing species follows Commission Regulation (EU) No 37/2010.
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- Sulfamonomethoxine Premix 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@sinochem-nanjing.com.
Sulfamonomethoxine Premix Veterinary Grade API is the 4-amino-N-(6-methoxy-4-pyrimidinyl)benzenesulfonamide entity supplied as a crystalline powder for downstream preparation of tablets, injectable solutions, capsules, water-soluble powders, granules, feed premixes, and oral solutions. The molecule has the formula C11H12N4O3S, a relative molecular mass of 280.30 g/mol, and CAS registry number 1220-83-3. The free acid form is sparingly soluble in water and soluble in dilute mineral acids and alkali hydroxides; the sodium salt and hydrochloride are the common salt forms used to raise dissolved concentration in liquid dosage forms. The veterinary-grade material is distinguished from generic chemical intermediate by controlled particle-size distribution, related substances, residual solvent profile, and freedom from N-acetylated by-products. Batch release documentation should include assay by potentiometric titration or HPLC, loss on drying, residue on ignition, heavy metals, and related substances. The material is intended for veterinary pharmaceutical manufacturing only and is not sterilized in bulk; terminal sterilization or aseptic processing remains a finished-product responsibility.
| Release parameter | Typical acceptance criterion | Reference method |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual examination |
| Assay on dried basis | 99.0–101.0% | Potentiometric titration / HPLC |
| Loss on drying | ≤0.5% | USP <731> |
| Residue on ignition | ≤0.1% | USP <281> |
| Heavy metals | ≤10 ppm | USP <231> or equivalent |
| Related substances total | ≤1.0% | HPLC USP <621> |
| Residual solvents | Meets ICH Q3C Option 1 | Headspace GC |
| Melting range | 203–206 °C | USP <741> |
What Distinguishes the 6-Methoxypyrimidinyl Substituent from Sulfadiazine and Sulfamethoxazole?
The 6-methoxypyrimidinyl group changes solid-state solubility and reversed-phase retention compared with sulfadiazine and sulfamethoxazole. Sulfadiazine contains an unsubstituted pyrimidine ring and is more hydrophilic; sulfamethoxazole carries a methylisoxazole substituent and is commonly co-formulated with trimethoprim at a fixed 5:1 ratio. Sulfamonomethoxine is typically employed as a single-agent veterinary premix or injection because the methoxy substitution slows metabolic acetylation and reduces renal clearance relative to sulfadiazine in certain species. The distinction should not be read as an efficacy ranking; minimum inhibitory concentration studies against target pathogens are required to establish clinical comparability. The methoxy group also alters photostability: aqueous solutions of the sodium salt develop coloured oxidative products unless protected from direct light. Related-substance retention times are compound-specific; a CoA generated for sulfadiazine cannot be used to release sulfamonomethoxine because chromatographic response factors and impurity windows differ.
Direct compression of the free acid is limited by poor flow and low bulk density. When the fraction of particles below 45 µm exceeds approximately 30% of the batch, segregation is observed in low-dose tablet blends containing less than 10% w/w active ingredient. Granulation is therefore preferred: a high-shear mixer operated at 150–300 revolutions per minute with a binder such as pregelatinized starch or polyvinylpyrrolidone yields granules that compress on a rotary tablet press. Fluid-bed drying is controlled below 60 °C to avoid adhesive softening in capsule filling. Hard gelatin capsule filling should be conducted at relative humidity below 50%. Lubrication with magnesium stearate at 0.5–1.0% w/w should be limited to less than 5 minutes of blending to avoid over-lubrication and delayed dissolution. The API is screened through a 60-mesh sieve before geometric dilution with lactose monohydrate or dibasic calcium phosphate dihydrate.
If the Free Acid Is Replaced by the Sodium Salt in Aqueous Injectable Systems
The sodium salt of sulfamonomethoxine is freely soluble in water but produces an alkaline solution. Injectable solutions are compounded by dissolving the salt in water at 20–25 °C, then adjusting pH with dilute hydrochloric acid or citrate buffer to a range that balances solubility with tissue tolerance. The pH should not fall below 8.5 if precipitation of the free acid is to be avoided; above 10.5 local irritation and oxidative discoloration may increase. Terminal sterilization by autoclaving at 121 °C for 15 minutes is used only after confirming that the solution remains clear and assay unchanged; otherwise membrane filtration plus aseptic filling is required. Multi-dose vials require preservative compatibility testing because sulfonamides can interact with benzyl alcohol and phenol derivatives. The free acid cannot be substituted directly into an aqueous injectable without a pH adjustment step because its water solubility is insufficient to reach therapeutic concentration.
Oral solutions and water-soluble powders are compounded from the sodium salt or from the free acid with sodium hydroxide. The resulting solution is buffered to pH 7.5–9.0 to retain the ionized form and reduce precipitation in hard water. Propylene glycol above 20% v/v may increase osmolality and reduce palatability in swine; the finished product should be evaluated for spontaneous drinking water intake. Sodium metabisulfite and potassium sorbate are evaluated as antioxidant and antimicrobial preservative, respectively, but sulfite adducts can form with sulfonamides and reduce assay values. Stability is established at 25 °C/60% RH for dry powders and at 4–8 °C for reconstituted liquids. Polyethylene terephthalate bottles provide lower water vapour transmission than low-density polyethylene and are preferred for tropical supply chains.
Premix Carrier Chemistry and Stability in Feed Matrices
Feed premix carriers must be non-reducing and low-moisture. Ground rice hulls, calcium carbonate, and corncob granules are used after drying to ≤9% moisture. Higher moisture supports hydrolytic cleavage of the sulfonamide bond and reduces recoverable active. Free choline chloride in vitamin-mineral premixes creates acidic microenvironments that can degrade sulfamonomethoxine during storage; if choline is required, the two fractions are separated in the final blend. Ribbon mixers with spray addition of vegetable oil at 0.5–1.5% w/w reduce dusting and improve adherence to carrier particles. Bulk bags should be stored off concrete floors at 15–25 °C and protected from light; retest intervals are based on stability-indicating HPLC assay after 6, 12, and 24 months. The product should not be blended with ionophore anticoccidials unless compatibility and segregation behaviour have been demonstrated.
| Dosage form | Critical process variable | Control method |
|---|---|---|
| Tablets | Blend segregation with low-dose API | Laser diffraction ISO 13320:2020; sieve analysis |
| Injectables | Free acid precipitation at pH < 8.5 | pH measurement USP <791> |
| Premix | Moisture and carrier acidity | Loss on drying USP <731>; pH suspension |
| Oral solution | Oxidative discoloration and sulfite adducts | Stability-indicating HPLC USP <621> |
Compared with sulfadimethoxine, which carries two methoxy groups at the 2,6 positions of the pyrimidine ring, sulfamonomethoxine is less lipophilic and elutes earlier on C18 reversed-phase columns under acidic mobile phases. This difference influences extraction solvent selection for residue monitoring and partition into feed lipids. Sulfadiazine is more hydrophilic and requires finer milling for uniform oral suspension; sulfamethoxazole is more extensively covered by human pharmacopoeial monographs and is usually combined with trimethoprim. Sulfaquinoxaline has a quinoxaline substituent and is used largely as an anticoccidial, so it is not interchangeable with sulfamonomethoxine in terms of withdrawal period or target indications. Selection among these sulfonamides should be based on approved species, minimum inhibitory concentration data, and withdrawal period, not only on in vitro activity or cost per kilogram.
Though Premix Grade Is Coarser, Micronized Tablet Grade Must Not Be Substituted Without Particle-Size Correlation
Premix grade is typically coarser than micronized tablet grade to reduce dusting and segregation in feed mills. Micronized material may have a D90 below 50 µm, whereas premix grade may have a D90 above 150 µm; however, these values are manufacturer-specific and should be read against batch CoA data. Substituting a coarse premix grade into a tablet formula will reduce blend homogeneity and may lower dissolution. Substituting a fine tablet grade into a feed premix may generate excessive dust and poor flow through volumetric metering equipment. The two grades share the same assay and related-substance requirements, but particle-size distribution and bulk density acceptance criteria differ. Supplier qualification should include X-ray powder diffraction if the crystallinity or polymorphic form changes, because crystal habit influences dissolution, settling, and electrostatic charge.
Related substances in the API include sulfanilamide and the N-acetylated metabolite. The acetyl derivative is the principal hepatic metabolite in animals and may appear as a synthesis-related impurity if the acetyl protection step is incomplete. HPLC methods using C18 columns and phosphate buffer–acetonitrile mobile phases separate the parent peak from the acetyl impurity with resolution greater than 2.0. The quantification threshold is typically 0.1% for individual impurities and 1.0% for total related substances. Melting range is measured by USP <741> and reported as 203–206 °C for the free acid. Loss on drying by USP <731> and residue on ignition by USP <281> are used to confirm low moisture and inorganic content. Methods are validated according to ICH Q2(R1) for specificity, linearity, accuracy, precision, and range. Batch-to-batch consistency is monitored with HPLC assay; validated methods are stability-indicating for the final dosage form.
The free acid should be stored in tightly closed containers at 15–25 °C, protected from light and moisture. Polyethylene bags inside fibre drums are a standard packaging configuration; aluminium-lined bags may be used for long-term storage in humid climates. Opened containers should be re-sealed under dry nitrogen and used within the manufacturer’s recommended re-test period. The product should not be stored near strong oxidizers, acids, or alkaline substances that can form salts or degrade the sulfonamide group. Sulfonamides are potential skin sensitizers; operators with known sulfonamide hypersensitivity should avoid contact. Local exhaust ventilation, nitrile gloves, and respiratory protection are used where dust is generated. Fine organic dust accumulations should be removed to reduce combustible dust hazards.
At the finished-product level, sulfamonomethoxine is administered orally in feed or drinking water for susceptible bacterial and coccidial infections and parenterally when immediate systemic exposure is required. The label must state the dose in milligrams per kilogram body weight, treatment duration, and species-specific withdrawal period. Prescription status varies; in many jurisdictions the product is restricted to veterinary use. Injectable solutions should be administered by a veterinarian or trained operator because alkaline solutions can cause pain or tissue necrosis if incorrectly injected.
Approval status differs by jurisdiction. The compound is included in some national veterinary pharmacopoeial monographs; in other regions, no maximum residue limit has been assigned. Finished-product manufacturers must confirm that the target species, indication, and withdrawal period are authorized in the country of use. Residue monitoring is performed by LC-MS/MS in official control laboratories. Bulk API documents should identify the manufacturing site, date of manufacture, retest date, and storage condition. A certificate of analysis is not a substitute for product registration; the marketing authorization holder retains responsibility for finished-product release.
