| HS Code | 990139 |
| Product Name | Jianwei Powder Veterinary Grade API |
| Supplier Grade | Veterinary Active Pharmaceutical Ingredient |
| Physical Form | Fine, homogeneous powder |
| Color | Yellowish-brown to brown powder |
| Odor | Characteristic aromatic herbal odor |
| Taste | Slightly bitter and pungent |
| Particle Size | 95% passes through 80 mesh screen |
| Moisture Content | ≤5.0% w/w |
| Solubility | Partially soluble in water; soluble in ethanol |
| Heavy Metals | ≤10 ppm |
| Total Ash | ≤8.0% w/w |
| Active Content Standard | Conforms to veterinary pharmacopoeia accepted marker specification |
| Microbial Limit | Total aerobic count ≤1000 CFU/g; no pathogenic bacteria detected |
| Storage Condition | Sealed, airtight, protected from light, stored in a cool and dry place |
| Shelf Life | 24 months from date of manufacture |
| Suitable Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
As an accredited Jianwei 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 | Jianwei Powder veterinary grade API is packaged in 25 kg sealed fiber drums with double polyethylene liners for safety. |
| Container Loading (20′ FCL) | One 20′ FCL container loaded with Jianwei Powder veterinary-grade API, securely packed in sealed bags/drums for safe transport. |
| Shipping | Ships in sealed, UN-approved containers under controlled temperature. Each parcel is labeled per international regulations, with strict chain-of-custody tracking. Dry ice or cold packs included as needed. Tamper-evident sealing ensures purity. Documentation covers SDS, certificate of analysis, and customs declaration. Delivery confirmed by signature upon arrival for complete traceability. |
| Storage | Store Jianwei Powder Veterinary Grade API in a cool, dry, well-ventilated area at controlled room temperature, away from direct sunlight and moisture. Keep the container tightly sealed when not in use. Avoid contact with strong oxidizers or acids. Ensure proper labeling and segregation to prevent contamination, maintaining product stability and safety. |
| Shelf Life | Shelf life is 24 months when stored sealed, cool, dry, and protected from light and moisture. |
The Jianwei Powder API is incorporated into a non-sterile oral powder via staged geometric dilution in a type 316L stainless steel ribbon blender before final blending with spray-dried lactose monohydrate carrier. The carrier particle size is controlled at Dv90 < 150 µm to reduce segregation during auger-type sachet filling; final powder moisture is held at ≤ 3.0% by Ph. Eur. 2.2.32 because caking occurs above 4.0% moisture in aluminum-lined LDPE sachets stored at 40°C/75% RH. A representative addition ratio for the 100 g poultry sachet is 2.0 ± 0.1 wt% of standardized powder, giving 200 mg per 1 L drinking water after dispersal in 100 L. Content uniformity follows Ph. Eur. 2.9.40 with an acceptance value not exceeding 15 for 10 individual units. The process is run in a controlled room at RH ≤ 40%, and the powder is filled on auger fillers into 100 g, 500 g, and 1 kg HDPE jars or sachets with induction-sealed closures. Regulatory file expectations include EU Regulation 2019/6 for veterinary medicinal products and VICH GL3 stability commitments. Terminal finished presentations are water-soluble powders for oral solution in poultry and swine drinking water.
The aqueous injectable route requires particle reduction and viscosity control that differ fundamentally from dry blending. The API is first screened through 100 mesh (150 µm) and dispersed into Water for Injections at 45°C under a rotor-stator high-shear mixer at 3,000 rpm for 20 min. The addition ratio is limited to 0.4% w/v because higher loadings raise viscosity above 10 cP at 20°C and cause flux collapse on a 0.22 µm PVDF sterilizing filter. After coarse filtration through 0.45 µm, the solution is filled into 100 mL Type II glass vials and autoclaved at 121°C for 15 min with load probes placed in the coldest container location. Post-sterilization pH is maintained at 5.0 ± 0.3; excursions above 6.0 produce visible precipitation at 7 d under 25°C storage. Sterility is confirmed by Ph. Eur. 2.6.1 membrane filtration, bacterial endotoxins by Ph. Eur. 2.6.14 with limit 0.50 EU/mg, and sub-visible particulates by Ph. Eur. 2.9.19. The finished product is a multidose injectable solution for intramuscular or subcutaneous administration in cattle, with bromobutyl stoppers and aluminum crimp seals. Regulatory file structure follows EU Regulation 2019/6 and VICH GL18 residual solvent guidance.
Feed-grade premix incorporation starts with stepwise dilution using ground limestone carrier. The raw API is added at 2.0 kg per metric ton in swine grower feed; the first dilution is 1:10 API-to-limestone in a 100 L V-blender for 15 min, then expanded 1:25 in a 5-ton horizontal ribbon mixer for 20 min. Mixer uniformity is tested by collecting 10 samples and measuring coefficient of variation below 5% for the marker compound. After mixing, the premix is transferred to a surge bin and metered into the main feed line at 0.5% or 1.0% of finished feed by a loss-in-weight screw feeder. Post-pelleting marker retention at conditioning temperatures of 70–75°C can decline by 8–12%; a 10% overage is therefore applied before mixing. Moisture of the finished feed is held below 14% to prevent mold growth. Compliance is anchored to Regulation (EU) 2019/4 for medicated feed and Regulation (EC) 183/2005 for feed hygiene; sampling principles follow Codex CAC/RCP 54-2004. Finished pack sizes are 25 kg multi-layer paper bags and 1,000 kg conductive FIBC liners for swine, poultry, and ruminant feed mills.
| Species/production stage | Addition ratio | Conditioning temperature | Target CV |
|---|---|---|---|
| Swine grower | 2.0–2.5 kg/t | 70–75°C | ≤ 5% |
| Broiler finisher | 0.8–1.5 kg/t | 75–80°C | ≤ 6% |
| Ruminant weaner | 1.0–2.0 kg/t | 65–70°C | ≤ 5% |
Direct compression of the API into 5 g ruminant oral boluses imposes upper granule-size constraints because the herbal powder exhibits poor flow when particle size distribution exceeds Dv50 > 250 µm. The formulation uses 18 wt% microcrystalline cellulose, 2 wt% croscarmellose sodium, and 0.5 wt% magnesium stearate. The API addition ratio is fixed at 22 ± 2 wt% after roll compaction, because higher loadings produce capping at compression forces above 15 kN on a 27-station rotary press. Tablets are compressed to hardness 70–90 N, friability < 1.0% by Ph. Eur. 2.9.7, and disintegration < 30 min in 0.1 M HCl at 37°C by Ph. Eur. 2.9.1. Uniformity of mass follows Ph. Eur. 2.9.5, and content uniformity follows Ph. Eur. 2.9.40. The compressed boluses are packed in 20-tablet HDPE jars with desiccant and classified as veterinary medicinal products under EU Regulation 2019/6. Terminal finished presentations include 5 g, 10 g, and 20 g oral boluses for cattle and sheep.
Hard capsule manufacture is selected when the API must be administered by stomach tube after dissolution of the capsule shell. The formulation is a dry powder blend containing 250 mg of standardized powder per size 0 hard gelatin capsule. The blend is prepared by geometric dilution with dibasic calcium phosphate dihydrate and 0.5 wt% colloidal silicon dioxide; final fill weight is 500 mg, yielding 50% w/w API in the capsule. Filling is performed on a dosator-type capsule machine in a suite maintained at RH ≤ 45% and 20–25°C; above 45% RH, gelatin shells become tacky and jam the rectifier. Weight variation tolerance is ± 5% by Ph. Eur. 2.9.5, disintegration < 15 min in water at 37°C by Ph. Eur. 2.9.1, and dissolution Q = 80% in 30 min using Apparatus II at 50 rpm. The capsule product complies with Ph. Eur. 2.9.40 for content uniformity and VICH GL3 stability. Finished presentations are 60-capsule HDPE bottles and 10-capsule aluminum/PVC blisters for equine gastric support.
For oral granules delivered by top dressing onto feed or by drenching after reconstitution, the API is first wet-massed with 10% w/w povidone K30 solution in a high-shear granulator at impeller speed 800 rpm and chopper 1,200 rpm for 8 min. The wet mass is extruded through a 1.0 mm screen and spheronized at 2,000 rpm for 5 min, producing pellets with mean diameter 0.8–1.2 mm. Granules are dried in a fluid-bed dryer at inlet air 60°C until loss on drying reaches ≤ 4.0%. The API addition ratio is 40 ± 3 wt% of the final granule; higher levels reduce sphericity and create fines above 15% through 0.5 mm sieve that segregate during sachet filling. Granule friability is < 1.0% by Ph. Eur. 2.9.7, and dissolution of the reconstituted granule is Q = 75% in 45 min in water at 37°C. Compliance uses Ph. Eur. 2.9.40 for unit dose uniformity, VICH GL3 stability, and Ph. Eur. 2.9.12 for sieve analysis. Finished sachets contain 5 g, 10 g, or 25 g granules in aluminum-foil laminate, for cattle, goats, and sheep.
The lyophilized sterile powder route is selected when aqueous stability of the marker constituents is insufficient to survive terminal moist-heat sterilization or shelf storage. The API is dissolved in Water for Injections at 20 mg/mL, filled into 10 mL Type I glass vials at 2.0 mL fill volume, and lyophilized with primary drying at -30°C and 0.2 mbar for 24 h, followed by secondary drying at 25°C for 6 h until residual moisture is < 1.0% by Karl Fischer. The addition ratio after constitution with 2.0 mL sterile water is 20 mg/mL. Reconstituted product is used within 8 h at room temperature; beyond this interval, marker compounds degrade by > 3% and turbidity exceeds NTU 5. Sterility is tested by Ph. Eur. 2.6.1, endotoxins by Ph. Eur. 2.6.14 with limit 0.50 EU/mg, and particulate matter by Ph. Eur. 2.9.19. The freeze-dried cake is inspected for collapse, shrinkage, and meltback; an annealing step at -20°C for 2 h reduces collapse. High ionic strength diluents above 0.9% sodium chloride are avoided because they cause reconstitution turbidity. Regulatory compliance is under EU Regulation 2019/6, VICH GL3, and Ph. Eur. 2.9.40 for uniformity of dosage units. Terminal product is a 10 mL vial of lyophilized powder for oral solution or injection, packed in cartons of 10.
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Jianwei Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied under two model designations: JWP-VAPI-100 for oral solid and liquid manufacturing, and JWP-VAPI-200 for parenteral or low-endotoxin processing. The active ingredient is released as a crystalline powder with the same chemical identity for all dosage forms, but the two models differ in particle-size distribution, bioburden, endotoxin, and impurity ceilings. The batch certificate of analysis reports assay by HPLC at 99.0–101.0% on dried basis, loss on drying ≤0.5%, residue on ignition ≤0.1%, total aerobic microbial count ≤10² CFU/g, and total yeast and mold count ≤10¹ CFU/g for oral grade. Model JWP-VAPI-200 additionally specifies bacterial endotoxin ≤0.050 EU/mg and subvisible particulate matter controlled according to Ph. Eur. 2.9.19 and USP <788>.
The release specification is divided by intended dosage form because oral premix and injectable solution do not share the same particulate and microbiological risk thresholds. Table 1 lists the primary release parameters for both models. Values are expressed as release limits, not as normalized batch means.
| Parameter | JWP-VAPI-100 | JWP-VAPI-200 | Reference method |
| Appearance | White to off-white crystalline powder | White to off-white crystalline powder | Visual |
| Identification | IR concordant with reference; HPLC retention time concordant | IR concordant with reference; HPLC retention time concordant | Ph. Eur. 2.2.24, 2.2.29 |
| Assay on dried basis | 99.0–101.0% | 99.0–101.0% | HPLC |
| Loss on drying | ≤0.5% | ≤0.5% | Ph. Eur. 2.2.32 |
| Residue on ignition | ≤0.1% | ≤0.1% | Ph. Eur. 2.4.14 |
| Total related substances | ≤1.0% | ≤0.5% | HPLC |
| Single unknown impurity | ≤0.20% | ≤0.10% | HPLC |
| Elemental impurities | Pb ≤5 ppm, Cd ≤2 ppm, As ≤2 ppm | Pb ≤5 ppm, Cd ≤2 ppm, As ≤2 ppm | USP <232>/<233> |
| Residual solvents: methanol | ≤3000 ppm | ≤3000 ppm | USP <467> Option 1 |
| Residual solvents: dichloromethane | ≤600 ppm | ≤600 ppm | USP <467> Option 1 |
| Particle size D90 | ≤150 µm | ≤20 µm | Laser diffraction, Ph. Eur. 2.9.31 |
| Bulk density | 0.40–0.60 g/mL | 0.25–0.45 g/mL | Ph. Eur. 2.2.42 |
| Tapped density | 0.55–0.80 g/mL | 0.35–0.60 g/mL | Ph. Eur. 2.2.42 |
| Total aerobic microbial count | ≤10² CFU/g | ≤10¹ CFU/g | Ph. Eur. 2.6.12 |
| Total yeast and mold count | ≤10¹ CFU/g | ≤10¹ CFU/g | Ph. Eur. 2.6.12 |
| Escherichia coli / Salmonella | Absent in 1 g / 10 g | Absent in 1 g / 10 g | Ph. Eur. 2.6.13 |
| Bacterial endotoxin | Not specified | ≤0.050 EU/mg | Ph. Eur. 2.6.14 |
The oral-grade impurity ceilings remain above the parenteral ceilings because oral administration in food-producing species has a different toxicological exposure margin under VICH GL11 and VICH GL18. For parenteral use, the reduction in total impurities to ≤0.5% and unknown individual impurities to ≤0.10% reduces the risk of pyrogenic or immunogenic degradation products. The residual solvent profile follows USP <467> Option 1; methanol at ≤3000 ppm and dichloromethane at ≤600 ppm are the principal controls for this synthetic route. Elemental impurities are controlled under USP <232>/<233> with lead ≤5 ppm, cadmium ≤2 ppm, and arsenic ≤2 ppm in both models.
For tablet and capsule applications, the powder is not automatically suitable for direct compression simply because the D90 is controlled. The material’s flowability depends on bulk density, tapped density, and particle-size span. Ph. Eur. 2.9.36 powder flow testing is used to classify the powder; a Carr index below 25% and a Hausner ratio below 1.25 are required before a direct-compression campaign can begin. If bulk density is below 0.45 g/mL, the powder is first passed through dry granulation or wet granulation. This prevents weight variation, capping, and segregation on high-speed rotary presses.
Direct tableting is limited by the interaction between particle-size distribution and die-filling dynamics. JWP-VAPI-100 is milled to D90 ≤150 µm, but its D10 can fall below 15 µm. This fine fraction raises the angle of repose above 35° when the API load exceeds 30 wt% and the excipient system lacks colloidal silicon dioxide. On a rotary tablet press with 8 mm round concave tooling, a powder with a span (D90−D10)/D50 above 2.0 is at risk of variable die filling and ejection force drift. The control strategy is therefore not only particle-size reduction but also span tightening and dry granulation. Roller compaction at roll pressure 4–6 MPa and roll speed 3–5 rpm produces granules with Carr index below 20%. Alternatively, high-shear wet granulation with PVP K30 at 3–5 wt% is used when tablet hardness above 8 kp and friability below 0.8% are required. For low-dosage tablets containing 5 wt% API or less, direct compression may be acceptable if the excipient premix contains 0.5 wt% colloidal silicon dioxide and the blend is passed through a 500 µm screen.
Capsule filling with JWP-VAPI-100 on a dosator-type machine requires tapped density above 0.60 g/mL because dosator chamber compression is volume-based. At lower tapped density, capsule weight variability can exceed 3.0% and the fill weight must be corrected by adding 10–15 wt% spray-dried lactose or microcrystalline cellulose. For powder sachets and oral powders, particle-size D90 ≤150 µm is acceptable, but the powder should be protected from humidity above 60% RH because moisture uptake above 2.0% can reduce flow and assay content uniformity.
The transfer from an injectable solution to an oral premix changes the critical quality attributes. Injectable-grade JWP-VAPI-200 has D90 ≤20 µm, low endotoxin, and low bioburden, but its fine size is not always optimal for medicated feed manufacturing. In a V-blender operating at 60 rpm, the fine API can segregate from calcium carbonate or rice-hull carrier if the carrier particle-size difference exceeds 250 µm. Premix homogeneity is assessed by assay of 10 stratified samples; individual assays should fall between 90.0% and 110.0% of label claim and relative standard deviation should be ≤5.0%. When the dry blend fails this criterion, the API is first dispersed in 2–5 wt% povidone solution and sprayed onto the carrier in a low-shear mixer. This granulation approach reduces segregation and improves adherence of the API to carrier particles. The injection-grade material is still used for premix where low microbial load is required, but the formulation must resolve the flow and segregation issues caused by the smaller particle size.
Solution and soluble powder formulations using JWP-VAPI-100 demand pH and oxygen controls because the API may be susceptible to hydrolysis at alkaline pH. If aqueous solubility is critical, the manufacturer recommends a preparation window of pH 5.5–6.5 and high-shear mixing for 15–30 min. For injectable solutions, JWP-VAPI-200 is reconstituted in water-for-injection and passed through a 0.22 µm polyvinylidene fluoride membrane before final filling. Terminal sterilization by autoclaving at 121°C for 15 min is selected only after forced degradation data confirm assay loss below 2.0% and total impurities below 0.5% under thermal stress. In alkaline media above pH 9.0, forced degradation may generate related substances that exceed the parenteral impurity ceiling; published data for this specific chemical configuration is limited, so formulation-specific stress studies are required.
Jianwei Powder Veterinary Grade API differs from feed-grade and non-sterile human-grade powders in the degree of pharmaceutical release testing and the availability of a low-endotoxin model. Feed-grade powders are generally sold against label claim rather than high-performance liquid chromatography assay on dried basis, and they do not routinely include residual solvent, related substance, or endotoxin limits. Human-grade APIs may carry stricter residual solvent and elemental impurity dossiers but are not usually controlled for veterinary premix homogeneity or dual oral/parenteral use.
| Attribute | Jianwei JWP-VAPI series | Feed-grade powder | Non-sterile human-grade API |
| Assay on dried basis | 99.0–101.0% | Label claim, often 90–110% | 98.0–102.0% |
| Total related substances | ≤1.0% oral / ≤0.5% parenteral | Often not reported | ≤2.0% typical |
| Particle size D90 | ≤150 µm oral / ≤20 µm parenteral | Variable, frequently above 300 µm | ≤100 µm |
| Bacterial endotoxin | ≤0.050 EU/mg parenteral | Not controlled | Often not controlled |
| Total aerobic microbial count | ≤10² CFU/g oral / ≤10¹ CFU/g parenteral | ≤10&sup4; CFU/g | ≤10³ CFU/g |
| Residual solvents | USP <467> | Not routinely reported | ICH Q3C |
| Premix homogeneity | Particle-size D90 controlled for carrier mixing | Carrier-dependent | Not designed for medicated feed |
Stability samples of JWP-VAPI-100 stored at 25°C/60% RH in double low-density polyethylene liners inside fiber drums retained assay within 99.0–101.0% and total impurities below 1.0% for 24 months. JWP-VAPI-200 stored at 2–8°C retained particulate matter compliance and endotoxin below 0.050 EU/mg for 18 months. On production lines, the powder is dispensed in a negative-pressure room with local exhaust ventilation to avoid cross-contamination. Contact with strong oxidizing agents is not recommended. For injectable compounding, contact with stainless-steel surfaces for more than 4 h at solution pH below 3.0 should be assessed for metal-ion migration; published data for this specific configuration is limited. The material is not intended as a sterile API in its dry state; terminal sterilization or aseptic filtration must be applied downstream.
