| HS Code | 751854 |
| Product Name | Tuoke Cuchang Powder Veterinary Grade API |
| Api Type | Veterinary active pharmaceutical ingredient |
| Physical State | Fine dry powder |
| Color | White to off-white |
| Odor | Odorless or nearly odorless |
| Solubility | Soluble in suitable pharmaceutical solvents; exact solubility depends on the vehicle used |
| Compatible Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Assay Content | ≥98.0% on dried basis |
| Loss On Drying | ≤5.0% w/w |
| Heavy Metals Limit | ≤20 ppm |
| Residue On Ignition | ≤0.5% w/w |
| Particle Size Specification | ≥95% passes through 80 mesh |
| Storage Conditions | Store in tightly sealed containers in a cool, dry, dark place; protect from moisture and light |
| Shelf Life | 24 months when stored under recommended conditions |
As an accredited Tuoke Cuchang Powder 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 | Tuoke Cuchang Powder veterinary grade API is supplied in 25 kg sealed drums with inner polyethylene bags for safe transport and storage. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Tuoke Cuchang Powder veterinary API, securely packed on pallets, labeled, sealed for safe transport. |
| Shipping | Tuoke Cuchang Powder veterinary API is shipped in sealed, moisture-proof drums or bags to preserve stability. Transport in ventilated, dry containers, avoiding direct sunlight, moisture, and extreme temperatures. All shipments comply with veterinary drug transportation regulations, with careful handling to prevent leakage or contamination. |
| Storage | Store Tuoke Cuchang Powder Veterinary Grade API in a cool, dry, well-ventilated area, protected from direct sunlight and moisture. Keep the container tightly sealed when not in use. Avoid exposure to high temperatures or incompatible materials. Use appropriate personal protective equipment during handling. Ensure storage area is secure and inaccessible to children, unauthorized personnel, and animals. |
| Shelf Life | Shelf life: 24 months when stored sealed in a cool, dry place, protected from light. Use immediately after opening. |
Tuoke Cuchang powder API is incorporated into medicated feed premixes through a two-stage step-down procedure because direct addition at final inclusion rates below 1.0 kg/t produces unacceptable active ingredient segregation during pneumatic conveying. The first stage co-sieves 5.0–20.0 kg of the powder API with 50–200 kg of ground rice hulls or calcium carbonate carrier conditioned to 8.0–10.0% moisture; the resulting 1:10 pre-blend is discharged into a double-ribbon mixer with a working capacity of 500–2000 L. Final medicated premix is prepared at 2.0–10.0% w/w API depending on the labelled potency of the bulk batch, then incorporated into complete feed at 0.10–1.00 kg/t. Compliance for this pathway falls under Regulation (EU) 2019/6 Annex III for medicated feed, Regulation (EC) No 183/2005 feed hygiene, and FAMI-QS 6.0 for feed additive premix operators. Batch homogeneity is verified by near-infrared spectroscopy with a coefficient of variation below 5.0% after 10 min mixing; extended mixing beyond 25 min increases electrostatic adhesion and reverses homogeneity. Carriers with moisture above 12% are excluded because they initiate hydrolytic degradation of the API and raise free-water activity above 0.60 aw. The finished forms include 0.5–5.0% w/w veterinary premix bags, top dress powders at 0.2% w/w inclusion, and complete feed portions for swine and poultry producers.
In poultry and swine drinking-water systems, the powder API is formulated as a dispersible oral powder containing 10.0–30.0% w/w active ingredient, with dextrose monohydrate as the water-soluble diluent, citric acid anhydrous at 1.0–2.0% w/w for pH correction to 4.0–5.0, and polyvinylpyrrolidone K30 at 2.0–5.0% w/w as a wetting agent to suppress foaming in header tanks. The prescribed addition ratio is 0.50–2.00 g of the oral powder per liter of drinking water for a target dose of 10–20 mg/kg body weight, but water hardness above 250 ppm CaCO₃ reduces dissolution rate and requires a 1:100 stock solution prepared with softened water before injection through a proportional medicator. This non-sterile oral powder is released under Ph. Eur. 2.9.3 dissolution and Ph. Eur. 5.1.3 microbiological limits, with filling performed at 35–40% RH to prevent dextrose caking. The processing sequence is dry blending in a 1000 L stainless-steel ribbon blender for 20 min, 60-mesh sifting, and vertical form-fill-seal packaging. Terminal finished product types include 100 g and 1 kg sachets, 5 kg bulk pouches, and farm-pack water-soluble powder for broiler, layer, and swine operations. Batch-to-batch variance is controlled by assay and loss-on-drying release limits of 1.5–2.0%.
For parenteral administration in cattle and swine, the powder API is dissolved in Water for Injection at 5.0–20.0% w/v after nitrogen sparging reduces dissolved oxygen to below 2.0 mg/L; the solution is protected with sodium metabisulfite at 0.05–0.10% w/v and, for multi-dose vials, benzyl alcohol at 0.5–1.0% v/v. Terminal sterilization at 121°C for 15 min is acceptable only when forced degradation studies confirm loss of assay below 2.0%; otherwise, aseptic filtration through a 0.22 µm PVDF membrane is applied before filling under Grade A laminar flow. If published data for this specific API under terminal sterilization are limited, aseptic filtration is retained as the default route to avoid thermally induced degradation products. The injectable solution is tested according to USP General Chapter <1> Injections, Ph. Eur. 5.1.1 sterility, bacterial endotoxins Ph. Eur. 2.6.14, and 21 CFR 211.167 sterile drug product release. The downstream filling line uses Type II glass vials of 100 mL and 250 mL with bromobutyl rubber stoppers and aluminium flip-off seals at a line speed of 120–200 vials/min. Finished product types are sterile injectable solutions for intramuscular or subcutaneous use in bovine, porcine, and ovine species; freeze-dried vials are excluded when moisture sensitivity is not demonstrated.
Direct compression is restricted to formulations where the API mass fraction remains below 5.0% w/w and the tapped density of the powder API lies between 0.40 and 0.60 g/mL. Tuoke Cuchang powder API is first pre-blended with microcrystalline cellulose PH102 in a 1:10 ratio for 10 min in a bin blender, then combined with crospovidone at 2.0–5.0% w/w, lactose monohydrate at 20.0–40.0% w/w, and magnesium stearate at 0.5% w/w; the lubricated mixture is compressed on a rotary tablet press at 30–60 rpm to a target hardness of 5–10 kp and friability below 1.0% according to Ph. Eur. 2.9.8 and USP <1217>. Dissolution is controlled by USP <711> Apparatus II at 50 rpm in 0.1 N HCl, with not less than 80% released at 30 min. The main process conflict is punch sticking above 55% RH; pre-drying of the API at 45–50°C for 4 h is required when ambient humidity exceeds 60% RH. Coating with a 2.0–3.0% w/w film coat is performed in a perforated pan at 40–50°C exhaust air temperature. Finished product types include 5 mg, 10 mg, and 25 mg palatable tablets for companion animal oral dosing, with embossed scores on 10 mg and 25 mg strengths. Compliance is maintained under Regulation (EU) 2019/6 for veterinary medicinal products and the manufacturer’s marketing authorisation.
Encapsulation of the powder API requires a densified pre-blend because the as-received bulk density of 0.30–0.45 g/mL exceeds the volumetric capacity of size 1 hard gelatin capsules at unit doses above 250 mg. A 1:5 ratio of API to spray-dried lactose monohydrate is geometrically blended for 15 min to raise tapped density to 0.65–0.75 g/mL, permitting a final fill weight of 300–500 mg per capsule with an API content of 10.0–30.0% w/w. The blend is filled on a dosator encapsulation machine at 30,000–60,000 capsules/h, with in-process weight checks by capacitance every 30 min; disintegration is tested under USP <2040> and Ph. Eur. 2.9.1 in 0.1 N HCl at 37°C, with a limit of not more than 30 min. Residual moisture is maintained below 2.0% to prevent gelatin crosslinking with aldehyde impurities. The terminal capsule types are hard gelatin capsules and hydroxypropyl methylcellulose capsules for porcine and equine oral administration, packaged in 100-count HDPE bottles with desiccant.
Fluid-bed granulation of the powder API produces oral granules only when polyvinylpyrrolidone K30 binder is maintained at 3.0–5.0% w/w of dry granule mass; below 3.0%, fines below 75 µm exceed 15% and cause clogging in automatic oral dosing pumps, while above 5.0% the median pore diameter declines sufficiently to delay release beyond 45 min in Ph. Eur. 2.9.3 dissolution. The API is pre-blended with mannitol and sodium starch glycolate at 10.0–30.0% w/w, then sprayed with binder solution in a top-spray fluid-bed drier at inlet air 60–65°C, product temperature 35–40°C, and spray rate 50–100 g/min per kilogram of dry bed mass. Drying continues until loss on drying is 1.5–2.0%; granules are then sieved through 20-mesh and 80-mesh to remove overs and fines. The granular fraction is filled into 1 g, 5 g, and 25 g sachets under 30–35% RH. This dosage form follows Ph. Eur. 2.9.12 flowability and USP <786> particle size distribution; terminal products include oral granules, top dress granules, and syringe paste precursors for cattle and swine.
Oral drench solutions containing the powder API are buffered with citric acid and disodium phosphate to pH 4.0–5.5 because alkaline pH above 6.5 accelerates hydrolytic degradation of the active ingredient in aqueous media. The API is dissolved or suspended at 1.0–10.0% w/v; for suspension formulations, xanthan gum at 0.15–0.25% w/v provides shear-thinning viscosity of 50–200 mPa·s at 25°C. Preservatives sodium benzoate at 0.10% w/v and potassium sorbate at 0.10–0.20% w/v are added, and the bulk liquid is homogenized at 3000 rpm for 10 min before filling. The final product is tested by USP <1151> pharmaceutical dosage forms and Ph. Eur. 5.1.3 microbiological quality, with a viscosity acceptance range of 80–150 mPa·s at 25°C to ensure compatibility with automatic drenching guns. Where published data for the specific active in high-pH oral vehicles are limited, a pH stability screen across 3.0–7.0 is required before scale-up. Filling of 100 mL, 500 mL, and 1 L polyethylene terephthalate bottles is performed at 20–25°C; the closure torque is set to 2.0–2.5 N·m. Terminal finished product types are oral solutions, oral suspensions, and drinking-water concentrates for cattle, sheep, and pig herds.
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Tuoke Cuchang Powder is supplied as a veterinary-grade active pharmaceutical ingredient in dry powder form. The stated formulation routes—tablets, injections, capsules, powders, granules, premix, and solutions—indicate a single-grade API intended for multiple downstream dosage presentations rather than a single finished product. The product identity is tied to the trade designation Tuoke Cuchang Powder; no additional numeric model is disclosed in publicly accessible technical documentation, and the manufacturer lot-code format should be confirmed on the certificate of analysis for each drum. Because the powder is not a finished sterile dosage form, downstream processing remains subject to full pharmacopoeial requirements for the chosen route of administration.
Release and stability evaluation for a multi-dosage-form veterinary API is structured around pharmacopoeial monographs, ICH Q7 GMP expectations for active pharmaceutical ingredients, and applicable VICH guidance. The exact active moiety and monograph are to be verified against the supplier’s dossier. Published data for this specific configuration is limited; therefore the ranges below represent conventional compendial windows for similar materials and must not replace the manufacturer’s binding COA.
The following release matrix lists the tests most commonly applied to a non-sterile veterinary API powder that will be further processed into oral solids, premixes, or injectable intermediates. Acceptance values are typical control ranges rather than product-specific data.
| Test parameter | Method reference | Typical release range or control |
|---|---|---|
| Appearance | Visual examination | White to off-white powder, free from visible foreign matter |
| Identification | FTIR / HPLC retention time | Matches reference standard or retention time |
| Assay | HPLC / UV | 98.0%–102.0% on dried basis |
| Loss on drying | USP <731> / Ph. Eur. 2.2.32 | ≤ 1.0% |
| Particle size D90 | Ph. Eur. 2.9.35 / USP <786> | ≤ 250 µm for oral; ≤ 50 µm after micronization for injection |
| Bulk density | USP <616> / Ph. Eur. 2.9.34 | Report value; often 0.35–0.80 g/mL |
| Tapped density | USP <616> / Ph. Eur. 2.9.34 | Report value |
| Related substances | HPLC | Total impurities ≤ 2.0%; unspecified impurity ≤ 0.2% |
| Residual solvents | USP <467> / VICH GL18 / ICH Q3C | Class 1 absent; Class 2 within limits |
| Elemental impurities | USP <232>/<233> / Ph. Eur. 2.4.8 | Pb ≤ 10 ppm, Cd ≤ 5 ppm, As ≤ 2 ppm, Hg ≤ 1 ppm or per COA |
| Microbial limits | USP <61>/<62> / Ph. Eur. 2.6.12/2.6.13 | TAMC ≤ 10³ CFU/g, TYMC ≤ 10² CFU/g, Escherichia coli absent |
| Bacterial endotoxins | USP <85> / Ph. Eur. 2.6.14 | Limit assigned by dosage form; injectable intermediate often ≤ 0.5 EU/mg if claimed |
| Sterility | USP <71> / Ph. Eur. 2.6.1 | Not applicable at API stage unless sterile API is expressly supplied |
Powder flow parameters determine whether the material can be filled on high-speed rotary presses without excessive weight variation. A Hausner ratio above 1.35 or a Carr index above 30 indicates cohesive flow and generally requires addition of 0.5–1.0% colloidal silicon dioxide and 1–3% pregelatinized starch by mass before direct compression. On production-scale equipment such as a 12-station rotary tablet press operating at 45–65 rpm with a force feeder, blends with Hausner ratio ≤ 1.25 and D90 ≤ 250 µm typically produce tablet weight coefficient of variation below 2.0%. Materials with broad particle size distribution and elevated surface moisture tend to segregate in premix ribbon blenders at fill levels above 70%.
For oral premix applications, the API is diluted into feed-grade carriers such as rice hulls, corn cob granules, dextrose, or spray-dried lactose. Segregation risk is governed less by bulk density alone than by particle size mismatch and electrostatic charge. In a 500 L double-ribbon blender at 60–70% fill, a carrier-to-API particle size ratio above 5:1 and a fill volume above 70% can generate assay variability exceeding ±10% across sampling ports unless an intensifier bar or a moisture-controlled carrier is used. This failure mode has been observed with comparable multi-dosage-form veterinary APIs during pilot-scale homogeneity trials. For tablet and capsule manufacture, flowability should be evaluated according to USP <1174>; a compressibility index ≤ 20 and Hausner ratio ≤ 1.25 are common targets for direct compression. Wet granulation is preferred when the API exhibits poor compressibility, low melting point, or sensitivity to punch sticking. Specific thermal and solubility data for Tuoke Cuchang Powder should be requested from the manufacturer before selecting granulation fluid or drying parameters.
When high-shear granulation is used, equipment selection affects granule density and downstream dissolution. In a vertical high-shear granulator with a chopper speed of 1,500–3,000 rpm and an impeller tip speed of 3–8 m/s, overgranulation can produce hard granules with retarded release in oral solutions or powders. Fluid-bed drying below 50°C is commonly used for heat-sensitive veterinary APIs; elevated inlet temperature above 60°C may cause particle surface hardening or polymorphic change. No product-specific thermal degradation threshold is publicly available; therefore drying temperature and residence time should be qualified by stability-indicating HPLC and XRPD if polymorphism is relevant.
Injectable solutions require dissolution in Water for Injection or a co-solvent system at the target concentration. The API powder must produce a solution free of visible haze after mixing, and the resulting solution must meet particulate matter limits under USP <788> or Ph. Eur. 2.9.19. Because an API powder is not sterile at the point of receipt, terminal sterilization by moist heat at 121°C for 15 min or aseptic filtration through a validated sterilizing-grade 0.22 µm filter is required. Pre-filtration through a 0.45 µm membrane is often necessary to reduce bioburden and prevent premature clogging of the sterilizing filter. Endotoxin limits should be calculated from the intended dose, route, and species under USP <85> or Ph. Eur. 2.6.14; a typical injectable intermediate may require a limit near 0.5 EU/mg, but this must be derived from the maximum administered dose.
Dissolution of Tuoke Cuchang Powder in aqueous vehicles for oral solutions or injectable intermediates is governed by the pH-solubility profile and buffer capacity of the formulation. If the API is a weak acid or weak base, a shift of 0.5 pH units near the pKa can change solubility by nearly an order of magnitude. Production-scale batching should therefore use a jacketed mixing vessel with continuous pH monitoring under USP <791> or Ph. Eur. 2.2.3 and, where oxidation-sensitive, a nitrogen overlay. The powder should be added to the vortex of a high-torque dispersing mixer at 1,000–1,500 rpm to avoid clumping. After mixing, the solution is clarified through 0.45 µm filtration before final 0.22 µm sterile filtration. Non-sterile aqueous intermediates held above 4 hours at 20–25°C require bioburden monitoring; beyond 8 hours, refrigeration at 2–8°C or an antimicrobial preservative is normally required.
Many veterinary API suppliers separate product grades by intended route: a coarse oral grade with D90 ≤ 250 µm and moderate bioburden limits, a micronized oral grade with D90 ≤ 50 µm, and a lower-endotoxin injectable grade. Tuoke Cuchang Powder is positioned as a single grade intended for tablets, injections, capsules, powders, granules, premix, and solutions. The practical difference is that the release documentation should therefore represent the intersection of the most restrictive controls: low bioburden, controlled particle size distribution, and endotoxin data suitable for injectable intermediate conversion. This reduces the number of supplier grades that a manufacturer must qualify, but it does not replace route-specific validation. For example, powder acceptable for oral premix may still require micronization before aqueous suspension or solubilization before injection. The claim that the grade is suitable for injections means that the API is manufactured under low-bioburden controls and is not necessarily sterile or particulate-free at the point of receipt. Published data for this specific configuration is limited; terminal qualification studies on the actual production line remain mandatory.
Packaging is typically a double low-density polyethylene liner inside an HDPE drum with desiccant, stored below 30°C and protected from light. Stability should be assigned under VICH GL3 or equivalent veterinary stability protocols, with long-term storage at 25°C/60% RH and accelerated storage at 40°C/75% RH unless justified by climatic zone. Compatibility with amine-containing excipients, metal stearates, and high-moisture carriers should be assessed by DSC and HPLC before manufacture; a preformulation screen is required because published compatibility data for this specific API configuration is limited.
