| HS Code | 153511 |
| Product Name | Wenglian Powder Veterinary Grade API |
| Product Classification | Active Pharmaceutical Ingredient (API) for Veterinary Use |
| Veterinary Grade | Yes - high purity raw material intended for veterinary pharmaceutical formulation |
| Physical Form | Fine powder |
| Active Substance | Wenglian (API) |
| Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Purity | ≥99.0% (HPLC) |
| Appearance | White or almost white crystalline powder |
| Solubility | Soluble in water, sparingly soluble in ethanol and methanol |
| Loss On Drying | ≤0.5% |
| Residue On Ignition | ≤0.1% |
| Ph Range | 5.0 - 7.0 (1% aqueous solution) |
| Heavy Metals Limit | ≤10 ppm |
| Storage Conditions | Store in sealed, dry, cool place away from direct sunlight |
| Shelf Life | 24 months |
| Packaging Options | 25 kg drum or as per customer specification |
As an accredited Wenglian 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 | Packaged in sealed, light-proof drums to maintain stability. Available in 25 kg net weight per drum. |
| Container Loading (20′ FCL) | One 20′ FCL container loaded with Wenglian Powder veterinary-grade API, securely packed in sealed drums on pallets for various formulations. |
| Shipping | Wenglian Powder Veterinary Grade API ships in sealed, moisture-proof drums or fiber containers, protected against contamination and degradation. Shipment requires dry, ventilated conditions, away from heat and incompatible substances. Transport by sea, air, or road is available, strictly following hazardous-material and veterinary pharmaceutical regulations. Proper labeling, documentation, and temperature control ensure safe global delivery. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature, away from heat, moisture, and direct sunlight. Keep containers tightly sealed to prevent absorption of humidity and contamination. Ensure segregation from food, feed, and incompatible substances. Follow veterinary pharmacopeial guidelines and use first-expiry-first-out rotation. |
| Shelf Life | Shelf life typically remains 2-3 years from manufacture date, provided the powder is kept dry, cool, and protected from light. |
During aseptic injectable manufacturing, Wenglian veterinary-grade API powder is normally released against anhydrous, solvent-free assay results, with water content corrected to ≤0.5% w/w before weighing. The active concentration in the final sterile solution is set at 10.0–200.0 mg/mL, equivalent to 1.0–20.0% w/v depending on target species dose, fill volume, and monograph potency; the remaining fraction consists of Water for Injections, 0.01–0.10 M citrate or phosphate buffer, sodium chloride for isotonicity adjustment to 270–330 mOsm/kg, and, where the API shows oxygen sensitivity, 0.05–0.10% w/v nitrogen-sparged antioxidant. Compliance is anchored to EU GMP Annex 1:2022, ISO 14644-1:2015 cleanroom class 5 in the fill zone, Ph. Eur. 2.6.14 bacterial endotoxin limits, USP <788> particulate matter, VICH GL18 residual solvent control, and ICH Q3D elemental impurity risk assessment. The downstream process uses a jacketed stainless-steel compounding vessel at 20–25 °C, dissolution with low-shear mixing at 150–300 rpm, pH adjustment to 5.5–7.4, and bioburden reduction through a 0.45 µm pre-filter followed by a sterilizing-grade 0.22 µm PVDF or PES filter. Post-dissolution hold time is normally validated at ≤4 h to maintain pre-filtration bioburden ≤10 CFU/100 mL, and filter integrity is confirmed by bubble point or forward-flow diffusion before and after filling. The resultant sterile solution is aseptically filled into Type I or Type II glass vials of 50 mL, 100 mL, or 250 mL nominal volume under laminar airflow, stoppered, and coded with the downstream batch record used for animal drug supply rather than human pharmacy inventory.
Weight variability in low-dose direct compression tablet lines is primarily governed by active-particle size distribution, electrostatic charging, and the point at which magnesium stearate is introduced. When the API fraction is limited to 0.8–5.0% w/w, the blend requires microcrystalline cellulose at 60–85% w/w, croscarmellose sodium at 1.0–3.0% w/w, and magnesium stearate at 0.25–0.75% w/w added only after the active-containing premix has been blended for 8–12 min; the API premix is passed through a 0.4 mm sieve and geometrically diluted in 1:10 steps to avoid agglomerates. Blending is performed in a bin blender at 8–12 rpm with 70–80% fill volume, and stratified sampling for USP <905> and Ph. Eur. 2.9.5 must return an acceptance value ≤15.0 at three phases of the batch. Tableting on a rotary press at 20–40 rpm turret speed and 8–15 kN mean compression force is controlled to tablet weight 200–800 mg, hardness 60–90 N, and friability ≤1.0% per Ph. Eur. 2.9.7. The main process conflict is segregation during bin discharge: active particles with D90 above 200 µm tend to migrate toward the free surface, so the docking station transfer is often fitted with a split valve and gravity assist rather than pneumatic conveying. Terminal product types include round or scored companion-animal tablets in aluminum/PVC blister packs or HDPE bottles, with the scored configuration reserved for dose-splitting lines where tablet hardness must remain within the 60–90 N band to avoid chipping at the score line.
Because medicated feed premixes are diluted into finished feed at inclusion rates below 5.0 kg/t, the API powder is dry-adsorbed onto a mineral or lignocellulose carrier before ribbon blending. The premix active loading is set between 1.0–20.0% w/w, and the finished feed concentration is adjusted through a second dilution step to 0.5–5.0 kg/t depending on target species and daily feed intake. Regulatory anchors include Regulation (EU) 2019/4 for medicated feed, Directive 2002/32/EC on undesirable substances in animal feed, and FDA 21 CFR 558 for new animal drugs used in medicated feed; sampling protocols are aligned to ISO 6497. Downstream processing uses a horizontal ribbon mixer with a batch size not exceeding 70% of gross volume and a mixing time of 10–15 min, followed by moisture verification at ≤5.0% w/w and particle-size distribution control at 0.5–1.25 mm. The critical control point is post-pelleting surge: if the API is thermolabile, the premix is introduced after pelleting to avoid steam conditioning at 70–85 °C; when heat-stable, it may be incorporated before conditioning only after a pilot-scale recovery study confirms no potency loss. Terminal product types are medicated feed premixes, oral powders, and top-dress granules supplied in 25 kg multi-wall bags with a homogenized drug content rather than in final pelleted form.
| Processing track | Primary regulatory/standard anchor | Critical test method | Numerical control point |
|---|---|---|---|
| Aseptic injectable | EU GMP Annex 1:2022 | Ph. Eur. 2.6.14 | Pre-filtration bioburden ≤10 CFU/100 mL |
| Low-dose tablet | USP <905> / Ph. Eur. 2.9.5 | Content uniformity AV | Acceptance value ≤15.0 |
| Feed premix | Regulation (EU) 2019/4 | ISO 6497 | Moisture ≤5.0% w/w |
| Oral granule | Ph. Eur. 2.9.36 | Powder flow | Ribbon density 1.10–1.30 g/cm³ |
| Lyophilized powder | FDA 21 CFR 212 | Ph. Eur. 2.5.32 | Residual moisture ≤1.0% w/w |
| Oral solution | Ph. Eur. 5.1.3 | Preservative efficacy | pH 5.0–7.5 |
Roller-compacted oral granule lines separate from feed-premix applications in that the final granule is typically packed into sachets or administered as top-dressing rather than diluted into a complete feed. The formulation addition ratio places the active fraction at 10.0–30.0% w/w, with povidone K30 binder at 0.5–2.0% w/w, lactose or maltodextrin filler at 45.0–80.0% w/w, and crospovidone or sodium starch glycolate at 2.0–5.0% w/w; colloidal silicon dioxide is kept below 1.0% w/w to avoid ribbon porosity loss. Compliance for flow and uniformity relies on Ph. Eur. 2.9.36 powder flow, USP <1174> flow character, and Ph. Eur. 2.9.5 for single-dose uniformity. The downstream process passes the pre-mix through a roller compactor with a roll gap of 1.0–2.0 mm and ribbon density controlled at 1.10–1.30 g/cm³, followed by oscillation sieving at 0.315–1.25 mm; fines below 0.315 mm are recycled at 20–30% of content weight to maintain friability without shifting the particle-size distribution. A process conflict arises when the active substance has low glass-transition or melting point, because roll-surface temperature above 30–35 °C can plasticize the ribbon and reduce granule porosity; published data for this specific API-dosage form configuration is limited, so compaction trials must be used to set roll speed rather than relying on reference-grade excipient settings. Terminal product types include oral granule sachets, flavored oral powders for reconstitution in drinking water, and top-dress powders for swine or poultry administration.
For reconstituted injectable powders, the API loading per vial is fixed between 25.0–500.0 mg, with mannitol or glycine at 2.0–10.0% w/v added as bulking agent, and buffer salts adjusted to yield a reconstituted pH of 5.0–7.0. Compliance is driven by FDA 21 CFR 212 veterinary drug CGMP, Ph. Eur. 2.6.1 sterility, Ph. Eur. 2.6.14 endotoxin limits, and Ph. Eur. 2.5.32 water micro-determination. The solution is filtered through a 0.22 µm sterilizing-grade membrane and filled aseptically into Type I glass vials before lyophilization; the freeze-dry cycle is segmented into freezing at −45 to −40 °C, primary drying at −20 to −10 °C under 50–150 µbar chamber pressure, and secondary drying at 25–35 °C until residual moisture is ≤1.0% w/w. The critical process boundary is collapse temperature: if the product temperature exceeds the collapse temperature during primary drying, the cake shrinks, reconstitution time increases, and moisture entrapment may fail Ph. Eur. 2.5.32. Before cycle scale-up, modulated differential scanning calorimetry and low-temperature scanning electron microscopy are used to confirm the glass-transition and collapse behavior of the formulated API, because published data for this specific API formulation is limited. Terminal product types are sterile lyophilized powders for injection, reconstituted with Water for Injections immediately prior to use in 10 mL or 20 mL diluent volumes.
Where water-soluble oral medication is required, the API powder is dissolved or suspended in a buffered co-solvent system instead of dry-powder blending. The active concentration in the final liquid is set at 5.0–50.0 mg/mL, with propylene glycol at 5.0–30.0% v/v, sorbitol solution at 10.0–30.0% w/v, and sodium benzoate or potassium sorbate at 0.1–0.2% w/v as preservative; the addition ratio of the API must be corrected for the as-is assay and for any volatile solvent residue referenced in VICH GL18. Compliance standards include Ph. Eur. 5.1.3 antimicrobial preservation, Ph. Eur. 2.2.7 pH measurement, and ICH Q3D elemental impurity screening. Downstream manufacturing uses a high-shear overhead mixer at 300–600 rpm, pH adjustment to 5.0–7.5, and a final polish filtration through 0.45 µm polypropylene or nylon membrane before volumetric filling into HDPE or amber PET bottles. The main process conflict is hydrolysis: if the pH drifts outside the 5.0–7.5 window during shelf life, potency loss can exceed the 95.0–105.0% label-claim acceptance band, so buffering capacity is verified by forced-degradation studies rather than by pH measurement alone. Terminal product types are oral solutions, drench formulations for cattle and swine, and drinking-water concentrates that require a separate dilution step at the farm level.
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Wenglian Powder Veterinary Grade API is a non-sterile active pharmaceutical ingredient powder supplied for subsequent pharmaceutical conversion into tablets, injections, capsules, powders, granules, premixes, and solutions. The material is identified by the descriptor “Wenglian Powder Veterinary Grade API”; no separate model number is assigned in public documentation, and route-specific particle-size grades are designated on the certificate of analysis by the intended dosage form. The powder is a white to off-white crystalline solid. Particle-size reduction is performed by air-jet milling or pin milling, and laser-diffraction analysis is conducted according to ISO 13320-1:2020. Batches are released with a certificate of analysis recording appearance, infrared identification, chromatographic assay, related substances, residual solvents, loss on drying, sulfated ash, elemental impurities, microbial enumeration, and, for injectable-grade lots, bacterial endotoxins. The product is not terminally sterilized as supplied; downstream facilities must apply validated sterile filtration, aseptic filling, or terminal sterilization to the finished dosage form. Manufacturing follows EU GMP Part II for active substances, with residual solvent control aligned to VICH GL18 and impurity characterization aligned to VICH GL11. Packaging is in 5 kg or 25 kg high-density polyethylene double-lined containers, with desiccant where required by market climate. The material should be sampled only under controlled relative humidity not exceeding 60% to prevent moisture uptake.
The matrix below summarizes representative release criteria used for a veterinary API powder of this grade. Exact limits are established in the approved veterinary medicinal product dossier and may vary by national monograph; the list is not a substitute for the receiving site’s pharmacopoeial compliance review. For injectable-grade material, the bacterial endotoxin test is performed by the limulus amebocyte lysate method per Ph. Eur. 2.6.14 or USP <85>. The acceptance criterion is derived from the finished-product dose and route; for small-volume injectables, a typical non-sterile API control point is ≤ 0.5 EU/mg. If the finished product is intended for intra-articular or intrathecal administration, stricter limits may apply.
| Parameter | Method | Acceptance criterion |
| Appearance | Visual inspection | White to off-white crystalline powder |
| Identification | Infrared absorption and HPLC retention time | Matches reference standard spectrum and retention time |
| Assay, dried basis | High-performance liquid chromatography | 98.0–102.0% |
| Related substances | High-performance liquid chromatography | Unspecified impurity ≤ 0.10%, total ≤ 0.5% |
| Residual solvents | Gas chromatography headspace | Class 1 not detected; Class 2 within VICH GL18 limits |
| Loss on drying | Oven / thermogravimetry | ≤ 0.5% w/w |
| Sulfated ash | Ignition | ≤ 0.1% w/w |
| Elemental impurities | Inductively coupled plasma-mass spectrometry | Per USP <232>/<233> and Ph. Eur. 5.20; As, Cd, Hg, Pb, Co, V, Ni limits verified |
| Particle size | Laser diffraction per ISO 13320-1:2020 | Oral grade d50 20–80 μm; injectable grade d50 10–30 μm; premix grade d50 75–150 μm |
| Bulk density / tapped density | Ph. Eur. 2.9.34 | Report value; Hausner ratio target ≤ 1.25 |
| Microbial limits | Ph. Eur. 2.6.12/Ph. Eur. 2.6.13 | TAMC ≤ 103 CFU/g, TYMC ≤ 102 CFU/g, absence of E. coli in 1 g |
| Bacterial endotoxins, injectable grade | Ph. Eur. 2.6.14 | ≤ 0.5 EU/mg or finished-product-derived limit |
The water content limit of ≤ 0.5% w/w is not a drying target alone; it reduces hydrolytic degradation during storage and limits sticking on high-speed tablet presses. Residual solvent testing by gas chromatography headspace must demonstrate absence of Class 1 solvents and compliance with Class 2 limits under VICH GL18; ethanol and acetone, when present, are reported on the certificate of analysis for compatibility with site solvent inventories. Elemental impurities are controlled by inductively coupled plasma-mass spectrometry against USP <232>/<233> and Ph. Eur. 5.20; limits for As, Cd, Hg, Pb, Co, V, and Ni are met by the raw-material supply chain and verified at intervals defined by the manufacturer’s risk assessment.
Air-jet milling at feed pressures of 6–8 bar and classifier speeds in the range 6,000–12,000 rpm produces injectable-grade particles with d50 values of 10–30 μm. The same equipment can generate fines below 5 μm if the classifier speed is raised without adequate feed rate control. Conversely, high feed rate at low classifier speed may produce a bimodal distribution that fails the d90 specification. On production-scale mills, batch-to-batch d50 variance is managed by monitoring mill differential pressure and grinding gas temperature; a differential pressure drift greater than 10% from the validated range signals nozzle wear or filter blockage. Pin milling for premix grades operates at lower specific energy and yields mean particle sizes in the 75–150 μm range. Post-milling blending in tumble or ribbon blenders is controlled by fill volume; target fill is 50–70% of working capacity, and mixing time is validated by blend uniformity sampling at 10 locations using validated HPLC. For injectable-grade powder, metal contamination from mill contact parts is limited to ≤ 10 ppm iron and ≤ 5 ppm chromium by in-line magnets and metal detectors; the powder must pass through a 250 μm safety screen before discharge.
Direct compression of Wenglian Powder into tablets is governed by particle-size distribution and residual moisture rather than by assay alone. Batches milled to a d90 below 150 μm improve blend uniformity in low-dose tablets; however, particles below 10 μm may increase cohesive arching in hoppers and require mechanical agitation or force feeders on high-speed rotary presses. For dry granulation, tapped density measured per Ph. Eur. 2.9.34 is recorded before roller compaction, and roll force is expressed in kN/cm with roll gap in mm. Wet granulation should use purified water or aqueous binder; if forced degradation data are absent, fluid-bed dryer outlet air temperature should not exceed 40 °C until thermogravimetric stability is confirmed. Capsule filling with dosator or tamping-pin machines benefits from free-flowing grades with a Hausner ratio below 1.25; fines can be dry granulated before filling. Injection-grade material must be dissolved under clean conditions and passed through 0.22 μm filters before aseptic filling. Powder sachets, granules, and premixes require geometric dilution; blend uniformity testing should follow applicable guidance with acceptance limits of 90–110% of label claim and relative standard deviation not more than 5.0%.
For solution formulations, critical processing variables are equilibrium solubility in buffered media, pH drift after reconstitution, and osmolality. The receiving formulator should measure equilibrium solubility in purified water, 0.1 M hydrochloric acid, pH 4.5 acetate buffer, and pH 6.8 phosphate buffer according to Ph. Eur. 5.11. If pH adjustment is required, dilute hydrochloric acid or citric acid should be added before tonicity-adjusting agents. Alkaline conditions above pH 8.0 are an operational boundary where hydrolytic or oxidative decomposition has not been excluded by forced degradation. Osmolality of injectable solutions should be adjusted to 285–310 mOsm/kg with sodium chloride or mannitol; hypertonic preparations may require slower intravenous administration. For oral drench solutions, palatability can be influenced by pH adjustment below taste-perception thresholds, but the pH change must not compromise chemical stability. The API is not supplied with a solubility-enhancing grade; particle-size reduction to 10–30 μm in injectable suspensions can increase dissolution rate but may increase viscosity and surface adsorption. Sterile filtration compatibility should be evaluated with 0.22 μm polyvinylidene fluoride filters; filter adsorption losses at low concentrations are a recognized operational boundary. Published data for this specific configuration is limited, and filter validation is therefore required on a product-specific basis.
For lyophilized presentations, the API may be dissolved in Water for Injection and freeze-dried; final cake appearance is excipient-dependent and is not an API property. The collapse temperature of the frozen solution should be measured by freeze-drying microscopy because primary drying shelf temperature must remain 2–5 °C below collapse temperature. This thermal characterization is formulation-specific and is not defined by the API alone, but injectable-grade powder with low endogenous pyrogen load and controlled particle size does not remove the requirement for thermal characterization. Endotoxin control remains a site-dependent parameter; if the API is exposed to open handling in non-classified areas, subsequent depyrogenation of the finished product may be compromised. For solutions that will be terminally sterilized, a product-specific thermal cycle must be validated with biological indicators and the physical-chemical stability of the active substance. If the product cannot withstand terminal sterilization, aseptic filtration and filling must be performed in an EU GMP Grade A zone with Grade B background, and filter integrity testing per ISO 29464:2019 or equivalent is required after filling.
Low-dose tablet and capsule lines encounter blend uniformity risks that are amplified by particle-size mismatch between API and excipients. Wenglian Powder lots intended for low-dose direct compression are characterized by d10, d50, and d90 using laser diffraction per ISO 13320-1:2020; the specification should be selected according to the dose-to-container volume ratio. If the d90 exceeds 250 μm, dry granulation is recommended before blending. High-shear mixer conditions should be recorded with impeller speed and chopper speed; for wet granulation, adding binder solution too rapidly can produce agglomerates with trapped fines, yielding tablets with visible specking but acceptable assay. Roller compaction parameters—roll force in kN/cm, roll gap in mm, and screen size—must be included in process development because these affect granule hardness and final tablet tensile strength. In feed premixes, geometric dilution in a ribbon blender with a loading volume of 50–70% is required; overloading above 70% reduces mixing efficiency and can leave undispersed API pockets. Spray-dried or wet-granulated grades may have lower dusting but are not necessarily compatible with moisture-sensitive matrix tablets. Storage of in-process granules at relative humidity above 60% increases sticking and can alter dissolution; enclosed transfer systems and desiccant-lined containers are required for tropical sites. These operational boundaries are determined during factory acceptance testing and should be revalidated when the API particle-size distribution changes by more than 10% in d50.
Wenglian Powder Veterinary Grade API differs from technical-grade powders and feed-grade additives in its release controls, route-specific particle-size grading, and residual solvent reporting. Unlike crude active powders used in non-pharmaceutical premixes, this grade is released with high-performance liquid chromatography assay in the range of 98.0–102.0% on dried basis and specified related-substance thresholds. A broader assay interval would be incompatible with finished veterinary medicines requiring VICH GL11 impurity characterization. A second difference is the controlled particle-size distribution; injectable-grade material is air-jet milled under dry nitrogen, while premix grades are blended in ribbon mixers to improve homogeneity in large-volume feed. A third distinction is the microbial and endotoxin control strategy. Non-sterile oral premix grades may be released with total aerobic microbial count not exceeding 103 CFU/g; injectable-grade lots are additionally tested for bacterial endotoxins by Ph. Eur. 2.6.14. This route-specific release strategy reduces the reformulation burden when a single API is used across tablets and parenterals, but it does not eliminate the need for facility-specific process validation. The product remains a single-chemical-entity veterinary active substance; it is not a formulated premix, not a diluted trituration, and not a sterile ready-to-administer injection.
Long-term storage data are generated at 25 °C ± 2 °C/60% RH ± 5% and accelerated data at 40 °C ± 2 °C/75% RH ± 5% according to VICH GL3. The manufacturer’s retest date on the certificate of analysis is based on these data; open-container stability at tropical humidity is not guaranteed. After first opening, the remaining powder should be resealed with desiccant and held under controlled room temperature; any transfer to unlined metal containers is unacceptable because the API may be reactive toward metal ions or traces of rust. Storage at 2–8 °C is not automatically required and can introduce condensation risk unless containers are equilibrated before opening. Cold-chain transport may be necessary only if the manufacturer’s stability protocol has demonstrated a negative temperature-dependent degradation rate; published data for this specific configuration is limited. For sites located above 1,000 m altitude, vacuum-sealed primary packaging should be opened in a controlled environment to avoid pressure-induced powder dispersion. These boundaries are operational rather than compendial; they are derived from standard pharmaceutical storage practice and from the physical form of the powder, not from a single accelerated test.
