| HS Code | 490587 |
| Productname | Wujiapi Qi Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Producttype | Veterinary grade herbal API |
| Synonyms | Wujiapi San; Acanthopanax Bark Powder; Five-leaf Ginseng Bark Powder; Wujiapi Qi San |
| Grade | Veterinary grade |
| Activeingredient | Wujiapi extract and qi-tonifying herbal components |
| Source | Acanthopanax gracilistylus root bark and related herbal extracts |
| Appearance | Brown to yellowish-brown fine powder |
| Odor | Characteristic herbal odor |
| Taste | Bitter and pungent |
| Solubility | Partially soluble in water; soluble in ethanol |
| Moisture | <=10.0% |
| Ash | <=10.0% |
| Heavymetals | <=20 mg/kg |
| Arsenic | <=2 mg/kg |
| Microbiallimit | Total aerobic count <=1000 CFU/g; mold and yeast <=100 CFU/g; E. coli absent |
| Assay | >=5.0% total flavonoids or >=0.5% syringin (typical) |
| Ph | 5.0-7.0 (1% suspension) |
| Particlesize | >=95% passes 80 mesh |
| Bulkdensity | 0.4-0.7 g/mL |
| Storage | Store in a cool, dry, sealed container, protected from moisture and light |
| Shelflife | 24 months |
| Packaging | 25 kg fiber drum with double polyethylene bags, or as required |
| Dosageforms | Tablets; Injections; Capsules; Powders; Granules; Premix; Solutions |
| Application | Used for formulating veterinary solid, liquid, and injectable dosage forms |
| Targetspecies | Livestock, poultry, companion animals, and aquatic animals as directed |
| Indications | Dispel wind-damp, strengthen tendons and bones, tonify qi, and support recovery |
| Administration | Oral, injectable, or premix according to veterinary prescription |
| Withdrawalperiod | As per local veterinary regulations |
| Regulatorystatus | Veterinary drug API; compliance with relevant veterinary pharmacopeia or enterprise standard |
| Manufacturingstandard | Enterprise standard or Chinese Veterinary Pharmacopoeia where applicable |
As an accredited Wujiapi Qi 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 | Wujiapi Qi Powder Veterinary Grade API packaged in 25 kg net double-lined fiber drums, suitable for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Container Loading (20′ FCL) | 20′ FCL container loading: Wujiapi Qi Powder Veterinary Grade API, suitable for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Wujiapi Qi Powder Veterinary Grade API is shipped in sealed, light-resistant, moisture-proof containers with tamper-evident closures. Orders are dispatched via air, sea, or courier under ambient or temperature-controlled conditions as required. Each shipment includes MSDS, COA, customs documentation, and regulatory labels to ensure safe handling and compliance. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature, protected from light and moisture. Keep container tightly closed when not in use. Keep away from heat, ignition sources, and incompatible materials. Maintain segregation from food, feed, and drinking water. Use appropriate containment to prevent dust generation and cross-contamination. Store away from children and animals. For veterinary use only. |
| Shelf Life | Shelf life depends on formulation and storage; typically 24 months when sealed, cool, dry, light-protected, per manufacturer’s stability data. |
Swine feed premix operations classify Wujiapi Qi Powder Veterinary Grade API as a micro-ingredient whose handling is governed by segregation mechanics rather than by chemical stability alone. The powder is typically received with a bulk density between 0.38 g/mL and 0.62 g/mL and a sieve residue of ≤5% above 150 µm. If the difference between the API bulk density and the carrier bulk density exceeds 0.15 g/mL, the pre-blend will stratify during discharge, producing an assay drift of ±12–18% across 10 grab samples. To control this, the API is first diluted with lactose monohydrate or rice hull meal at 2–5 wt% of the final batch mass, passed through a 500 µm conical screen, and then loaded into a 1,000 L ribbon mixer at 80% working volume with an impeller speed of 15 rpm. The main mixing interval is 8–12 min; extending it beyond 15 min does not improve homogeneity and increases electrostatic carryover and dusting.
The relevant compliance framework for this route includes Regulation (EC) No 183/2005, Directive 2002/32/EC, GMP+ B1, and FAMI-QS. For residual solvent control in the dried extract, batch release should include limits under VICH GL18. The addition ratio is dose-derived: for a target dose of 20 mg/kg bodyweight and a daily feed intake of 4% bodyweight, the complete-feed level is 500 mg/kg, equivalent to 0.5 kg/t. A 10 kg/t premix intermediate therefore requires 50 g/kg API; the 25–100 g/kg range in the premix corresponds to final feed levels of 0.25–1.0 kg/t. Finished product types include medicated feed premix, top-dress powder, starter feed, and sow lactation feed. Carryover cleanup after each batch is verified by swab limits no greater than 1/1000 of the smallest batch API dose.
The production constraint in poultry drinking-water granules is the balance between granule hardness and instant dissolution. In a 120 L fluid-bed granulator, Wujiapi Qi Powder Veterinary Grade API is loaded at 10–30 wt% of the dry granule mass with lactose monohydrate or sorbitol as filler and 3–5 wt% povidone K30 as binder. The spray rate is maintained below 120 g/min; when the spray rate exceeds this value at an inlet air temperature of 65°C, the granules form hard agglomerates and the reconstitution time increases from 4 min to more than 15 min in water at 25°C. The drying endpoint is controlled at a product temperature of 35–45°C and a loss-on-drying limit of ≤3.0%. The dried granule fraction is sieved between 200 µm and 850 µm; fines below 200 µm are recycled or removed because they create dust during sachet filling and can segregate in multi-dose packaging.
For drinking-water application, the granule active loading is selected so that a 10 g sachet containing 30 wt% API delivers 3 g active material, sufficient to prepare 100–200 L of stock solution at 15–30 mg/L. The final water concentration is derived from the prescribed dose and the flock’s water intake; at a daily water intake of 20% bodyweight, a target dose of 10 mg/kg corresponds to 50 mg/L. The solution is buffered to pH 5.5–6.5 because hard water above pH 8.5 slows hydration and increases haze. Compliance in this route is governed by EU Regulation 2019/6 for veterinary medicinal products, with dissolution checked under Ph. Eur. 2.9.3 and moisture determined by USP <921>. Terminal finished product types are water-soluble granules, oral powders, and concentrated stock solutions for proportioner dosing.
Sterile compounding of Wujiapi Qi Powder Veterinary Grade API requires a defined control sequence because the extract is not a single-molecule drug substance. The dry API is first dissolved in Water for Injection at 25–35°C under high-shear mixing; the maximum solution load is held at 0.1–0.5% w/v, or 100–500 g per 100 L batch. Above 0.5% w/v, polysaccharide-rich fractions raise viscosity beyond 5 cP, and the 0.22 µm PVDF final filter capacity falls below 10 L/m². The solution is adjusted to pH 5.5–6.5 with citric acid or sodium citrate, and tonicity is set at 280–320 mOsm/kg using sodium chloride or mannitol. A 0.45 µm polypropylene prefilter is placed upstream of the final 0.22 µm membrane to remove aggregates and reduce premature blocking.
The sterile process boundary is that autoclaving at 121°C for 15 min is permitted only after the specific CoA lot passes a thermal-challenge test for color change and sub-visible particle increase. If the extract contains heat-sensitive polyphenols or reducing sugars, aseptic filtration in an ISO 14644-1 class 5 area is used instead. Compliance includes EU GMP Annex 1, Ph. Eur. 2.6.14 for bacterial endotoxins, Ph. Eur. 2.9.19 for particulate contamination, and USP <788> for injection particulate limits. Residual solvent release follows VICH GL18. Terminal finished product types are aqueous injectable solutions and sterile liquid parenterals for swine and cattle. Published filter-loading data for this specific botanical extract in Water for Injection are limited; a filter compatibility trial on each incoming lot is required before scale-up.
When the powder is moved from warehouse to compression, the main failure mode is sticking and picking on punch faces, driven by hygroscopic uptake above 55% RH. The API is therefore pre-dried in a vacuum tray dryer at 40–50°C and ≤40% RH until the loss-on-drying value is ≤5.0%. The tablet formula uses 100–300 mg of Wujiapi Qi Powder Veterinary Grade API per unit, corresponding to 15–40 wt% of the core. Microcrystalline cellulose is included at 30–50 wt%, croscarmellose sodium at 2–5 wt% as disintegrant, colloidal silicon dioxide at 0.5–1.0 wt% as glidant, and magnesium stearate at 0.5–1.5 wt% as lubricant. The magnesium stearate level is kept below 1.5 wt% because higher levels delay disintegration beyond 15 min when the tablet hardness exceeds 120 N.
Compression is conducted on a rotary press with a 16-station turret at main compression force between 8 kN and 14 kN. Target hardness is 80–150 N, friability is controlled below 1.0% under USP <1216>, and disintegration time is verified under Ph. Eur. 2.9.1. Content uniformity follows USP <905>; residual solvent control follows VICH GL18; the finished veterinary medicinal product is placed under EU Regulation 2019/6. Terminal product types are chewable tablets, scored tablets, hard capsules filled with the same granulation, and larger oral boluses for companion animals. When wet granulation is required, the product temperature must not exceed 45°C because the botanical extract becomes tacky and non-dischargeable from high-shear granulators.
Ruminant oral drench production differs from dry premix handling because the API is introduced into a liquid vehicle where polysaccharide hydration controls both viscosity and dosing accuracy. In a 2,000 L stainless-steel compounding vessel, Wujiapi Qi Powder Veterinary Grade API is dispersed at 10–30 g/L under a high-shear mixer running at 3,000 rpm for 15 min. The vehicle contains propylene glycol at 5–15% v/v to suppress gelation, sodium benzoate at 0.1–0.2% w/v as preservative, and citric acid buffer to hold pH at 5.5–6.5. If the batch viscosity exceeds 100 mPa·s at 25°C, filling pumps show volumetric drift and neck-drip increases; the solution is then diluted or the mixing time is extended. After compounding, the liquid is passed through a 10 µm clarification filter and stored in closed stainless-steel tanks before filling.
The addition ratio is dose-derived. At a dosing volume of 0.5 mL/kg bodyweight, a 20 g/L solution delivers 10 mg/kg bodyweight. Compliance is governed by EU Regulation 2019/6, residual solvent limits under VICH GL18, and preservative efficacy testing under Ph. Eur. 5.1.3 for multi-dose containers. When well water is used for dilution at the farm, a 1:10 dilution sample should not exceed 10 NTU turbidity; higher turbidity indicates precipitation and requires softened water or a chelating agent before release. Terminal finished product types include oral drench, liquid feed supplement, and ruminal intubation solution.
Pre-extrusion addition of polysaccharide powders to aquafeed lines creates a measurable recovery loss when the die temperature exceeds 85°C. In a twin-screw extruder with an L/D ratio of 25:1 and a die temperature of 105–125°C, direct addition of Wujiapi Qi Powder Veterinary Grade API before the preconditioner can reduce marker recovery by 20–35%, with the loss concentrated in the barrel zone where melt viscosity is highest. The preferred process is therefore post-extrusion vacuum coating: the API is dispersed in fish oil or vegetable oil at 0.5–2.0 wt% of pellet mass and sprayed onto pellets at 60–70°C under a vacuum of −0.08 MPa. This keeps the thermal exposure below 85°C and avoids the high-shear barrel section entirely.
The finished feed addition ratio is 1–5 kg/t, but the ratio is dose-derived and must be adjusted to the prescribed in-water or in-feed dose. For a daily feed intake of 2% bodyweight, a target dose of 10 mg/kg bodyweight corresponds to 500 mg/kg feed. Compliance for this route includes Regulation (EC) No 183/2005, Directive 2002/32/EC, GMP+ B1, and ISO 22000. Terminal finished product types are extruded sinking pellets, floating pellets, and top-dressed aquafeed. Because published retention data for this specific extract under extrusion temperatures are limited, each production line should undergo a mass-balance trial before commercial batch release.
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Wujiapi Qi Powder Veterinary Grade API is produced from the dried root bark of Acanthopanax gracilistylus (syn. Eleutherococcus gracilistylus) and is supplied as a brown-yellow fine powder for incorporation into tablets, injections, capsules, powders, granules, premixes, and solutions. The veterinary-grade designation is not a label alteration; it imposes a defined particle-size cut, heavy-metal and mycotoxin limits, and microbial/endotoxin controls that are commonly required by licensed veterinary formulation facilities. The product is standardized to total phenylpropanoid glycosides expressed as syringin equivalents, with identification by thin-layer chromatography and high-performance liquid chromatography against authenticated botanical reference material.
The model differentiation follows the intended manufacturing route. The oral solid and premix grade is designated by a target particle size of D90 ≤ 74 µm, corresponding to a 200 mesh sieve boundary, and the parenteral/solution grade is designated by a further micronized target of D90 ≤ 25 µm. This two-grade approach exists because filter blinding, suspension settling, and powder segregation are controlled by particle-size distribution rather than by chemical marker assay alone. Release documentation includes species-specific batch traceability from the botanical collection site through milling and blending. The powder is packed in double polyethylene liners inside sealed HDPE drums; each drum is labeled with the assigned grade and certificate-of-analysis lot number.
Direct injection of Wujiapi Qi Powder is constrained by water-insoluble lignified cell-wall fragments and hydrophobic triterpenoid components. When the powder is dispersed in water for injection without pre-clarification, a sterilizing-grade polyethersulfone membrane with a pore size of 0.22 µm can blind within 2–5 min at a differential pressure of 0.2 MPa. The parenteral route therefore uses staged clarification: a glass-fiber depth prefilter at 1.0 µm, a membrane prefilter at 0.45 µm, and final filtration at 0.22 µm. The aqueous vehicle is maintained at pH 5.5–7.0; above pH 8.0, hydrolysis of phenylpropanoid glycosides accelerates, and below pH 3.0, acid-catalyzed glycosidic cleavage may occur. Sterile filtration run time and filter integrity must be qualified per ISO 13408-2, and visible particles must meet USP <790> criteria. Published data for this specific botanical configuration is limited, so filter-loading studies are required for each batch.
For tablets and capsules, the same oral-grade API is wet-granulated with 2.5–5.0% w/w polyvinylpyrrolidone K30 solution. Wet mass is screened through a 1.0 mm mesh and dried in a fluid-bed drier with inlet air not exceeding 55 °C. At inlet air 60–65 °C, the granule surface darkens and the HPLC area of syringin-related markers declines; this is the primary thermal boundary for oral solid processing. Final moisture is controlled at 3.0–5.0% because lower moisture increases friability, while higher moisture reduces tablet hardness and extends disintegration. If the powder has been exposed to ambient conditions above 60% RH, pre-drying at 45–50 °C for 4–6 h in a tray dryer is recommended before dry granulation.
In premix and powder applications, Wujiapi Qi Powder is typically added at 0.1–2.0% w/w to a mineral or grain carrier with particles between 500 µm and 1,000 µm. Because the active powder is finer than the carrier, vibration and pneumatic transfer can stratify the blend. Blend uniformity is therefore monitored by assay of the marker compound across 10 sampling points; a coefficient of variation of ≤ 5.0% is accepted for release. A ribbon blender with a fill volume of 50–70% and mixing time of 60–120 s after pre-blending produces acceptable distribution; adding 1.0% vegetable oil before final mixing reduces dust and improves adhesion to coarse carrier particles. If the blend is fed through a screw conveyor, the hopper must be designed for mass flow because rat-holing has been observed with cohesive botanical powders at moisture above 6.0%.
| Parameter | Oral solid / premix grade | Injection / solution grade | Reference basis |
|---|---|---|---|
| Particle size, D90 | ≤ 74 µm | ≤ 25 µm | ISO 13320 |
| Loss on drying | ≤ 10.0% | ≤ 5.0% | USP <731> |
| Total ash | ≤ 8.0% | ≤ 5.0% | USP <561> |
| Acid-insoluble ash | ≤ 1.0% | ≤ 0.5% | USP <561> |
| Elemental impurities | ≤ 10 ppm total heavy metals | ≤ 5 ppm total heavy metals | USP <232>/<233> |
| Total aerobic microbial count | 104 CFU/g max | 102 CFU/g max pre-sterile | USP <61> |
| Total yeast and mould count | 102 CFU/g max | 101 CFU/g max | USP <61> |
| Bacterial endotoxins | not specified | < 0.5 EU/mg if intended for parenteral use | USP <85> |
| Aflatoxin B1 | ≤ 5 µg/kg | ≤ 5 µg/kg | USP <561> |
| Marker content, syringin equivalents | reportable | reportable | HPLC method |
On a rotary tablet press, the granulated Wujiapi Qi Powder compresses acceptably at 8–15 kN when the granule moisture is held between 3.0% and 5.0% and the bulk density after granulation is at least 0.45 g/cm³. Tablets compressed below 8 kN show edge friability and capping; above 15 kN, the botanical gum components can cause punch sticking and longer disintegration times. Target hardness is 70–120 N, and disintegration in 0.1 M hydrochloric acid at 37 ± 2 °C is maintained below 30 min per USP <701>. Direct compression is generally not suitable for this API because the cohesive powder has poor flow and low bulk density; a dry granulation or slugging step is therefore used.
| Dosage form | Typical API level | Critical equipment | Primary control point |
|---|---|---|---|
| Tablet | 10–30% w/w | rotary tablet press, 8–15 kN | hardness 70–120 N; disintegration <30 min |
| Capsule | 100–500 mg granulated fill | dosator or tamping pin encapsulator | fill weight ±5%; flow > 10 g/s |
| Powder | 0.5–5.0% w/w | ribbon blender | blend CV ≤ 5.0% |
| Granule | 10–50% w/w granulated | fluid-bed drier | inlet air ≤ 55 °C; final moisture 3.0–5.0% |
| Premix | 0.1–2.0% w/w | mass-flow hopper, screw conveyor | marker CV ≤ 5.0%; moisture <6.0% |
| Solution | 5–20 mg/mL dry extract equivalent | stainless mixing tank, 0.45 µm prefilter | pH 5.5–7.0; clarity |
| Injection | 5–20 mg/mL dry extract equivalent | aseptic fill line, 0.22 µm sterilizing filter | sterility, endotoxin <0.5 EU/mg |
For injectable solutions, the biological load of the starting powder is only one part of the control strategy. Botanical powders can carry endotoxins that are not removed by 0.22 µm filtration because endotoxin molecules may be smaller than the membrane pore or may pass as dispersed aggregates. The raw powder must therefore be tested with USP <85> and released with an endotoxin limit of <0.5 EU/mg for parenteral use. Dry-heat depyrogenation at 250 °C for 30 min is not applicable because it would thermally destroy the phenylpropanoid markers. Instead, aseptic processing with sterile filtration is the primary sterility mechanism, and the hold time between final sterile filtration and fill completion is controlled to prevent bioburden regrowth. The solution may be filtered through a 0.45 µm prefilter and then through a 0.22 µm polyvinylidene fluoride or polyethersulfone membrane; filter compatibility with the co-solvent system must be confirmed because high levels of ethanol or propylene glycol can extract membrane components. Subvisible particulate testing is performed according to USP <788> for large-volume injections and USP <789> for small-volume injections.
For oral drenching solutions, the API is dispersed in a buffered vehicle and homogenized at 2,000–3,000 rpm for 15–20 min to hydrate polysaccharides. Clarification through a 45 µm screen prevents sprayer clogging. These oral solutions are not required to be sterile but must meet microbial limits for oral liquids according to USP <61> and USP <62>.
The veterinary-grade API differs from crude Wujiapi bark powder in particle size, microbial burden, heavy-metal content, and procedural documentation. Crude root bark may enter a veterinary pharmacy or feed mill with total aerobic counts above 105 CFU/g and irregular particle size; the API is milled and sieved to a defined D90 and tested against pharmacopoeial acceptance criteria. Compared with a synthetic small-molecule veterinary API, Wujiapi Qi Powder is a multi-component botanical complex. It cannot be released by a single purity value; it requires chromatographic fingerprinting, marker assay, and limits for foreign organic matter, ash, and contaminants. The presence of polysaccharides and lignified debris introduces filter-fouling potential and viscosity effects in liquid dosage forms, which are not observed with most crystalline synthetic APIs. Compared with food-grade botanical powders, this veterinary-grade material includes documentation suitable for veterinary drug applications: batch records, residual solvent data where applicable, and stability data for the assigned grade.
The powder is hygroscopic above 60% RH; storage in sealed HDPE drums with desiccant below 25 °C and 60% RH is required to prevent caking and microbial growth. Incompatibility with strong oxidizing agents and with aqueous media below pH 3.0 should be assumed until formulation-specific stability data are available. The API should not be combined with amine-based additives unless compatibility has been demonstrated, because botanical polyphenols can undergo amine-catalyzed oxidation and color change. For food-producing animals, withdrawal-period data must be generated for the finished product because the metabolic fate of multiple phenylpropanoid glycosides is not fully described in all target species.