| HS Code | 211058 |
| Productname | Jin Qiaomai Tablets Veterinary Grade API |
| Activeingredient | Fagopyrum dibotrys (Jin Qiaomai) extract |
| Botanicalsource | Fagopyrum dibotrys (D.Don) Hara aerial parts and roots |
| Grade | Veterinary grade |
| Intendeduse | Active pharmaceutical ingredient for veterinary drug manufacturing |
| Compatibledosageforms | Tablets, injections, capsules, powders, granules, premix, solutions |
| Appearance | Brownish-yellow to brown powder |
| Solubility | Partially soluble in water; soluble in dilute ethanol |
| Storageconditions | Sealed, cool, dry place; protected from light |
| Shelflife | 24 months when stored under recommended conditions |
| Packaging | 1 kg, 5 kg, 25 kg sealed bags or drums |
As an accredited Jin Qiaomai Tablets 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 | Jin Qiaomai veterinary-grade API: packaged in sealed 25 kg drums with double polyethylene liners, moisture-proof, light-resistant, and clearly labeled for pharmaceutical use. |
| Container Loading (20′ FCL) | 20′ FCL container loading for Jin Qiaomai Tablets veterinary-grade API, safely packed and secured for transport of bulk powders/injections. |
| Shipping | Shipping of Jin Qiaomai Tablets Veterinary Grade API follows strict cold-chain and moisture-controlled protocols. Packaging uses sealed, double-layer pharmaceutical-grade containers with desiccants. Shipments include safety data sheets, veterinary API certificates, and customs-compliant documentation. Transport is via temperature-monitored couriers, ensuring stability, purity, and regulatory compliance throughout delivery. |
| Storage | Store sealed in a cool, dry, well-ventilated area at controlled room temperature, protected from moisture, direct sunlight, and strong light. Keep container tightly closed when not in use. Avoid exposure to high heat or humidity. Ensure area is clean and free from contaminants. Use appropriate handling procedures and keep out of reach of children and animals. |
| Shelf Life | Shelf Life: 24 months when stored in original sealed containers, protected from moisture, light, and temperatures below 25°C. |
For poultry operations, Jin Qiaomai Tablets Veterinary Grade API is formulated into a water-soluble oral powder by a short wet granulation route: the active fraction is combined with dextrose monohydrate and anhydrous citric acid in a high-shear mixer, granulated to an endpoint of 12–15% w/w moisture, then dried in a fluid-bed dryer at 55–65°C inlet air until loss on drying falls below 3.0% w/w. The dry powder is filled into aluminum-laminated sachets at 80 g, 200 g, or 1 kg pack sizes. In the drinking-line stock solution, a working concentration of 2.0 g/L reconstituted powder is commonly used; the formulation addition ratio for the bulk powder is 20% w/w active fraction with 0.3% w/w citric acid to maintain reconstituted pH at 4.5–5.5. Microbiological quality follows Ph. Eur. 5.1.4 for oral non-sterile preparations, and assay uniformity is verified by a VICH GL1-validated HPLC method. The product falls under EU Regulation 2019/6 for veterinary medicinal product authorisation in food-producing species. Hard water with total hardness above 250 mg/L CaCO₃ can depress recovery because polyphenol fractions form sparingly soluble calcium complexes; in such water, the API concentrate is added to a bypass dosing tank fitted with a paddle mixer rather than injected into high-hardness mains headers, avoiding precipitation inside nipple drinker lines. The terminal finished product type is a water-soluble oral powder sachet that is reconstituted at farm level to a 0.2–0.5% w/v drinking solution.
Direct compression of Jin Qiaomai Tablets Veterinary Grade API in companion animal solid dosage forms is feasible only after the API is spray-dried with a coprocessed carrier to improve flow; otherwise, the extract’s fine particle size and poor compressibility produce weight variation outside USP <905> acceptance criteria on high-speed rotary presses. A robust formulation uses 25–40% w/w active fraction, 45–55% w/w microcrystalline cellulose, 8–12% w/w lactose monohydrate, 2–5% w/w croscarmellose sodium, 0.5–1.0% w/w magnesium stearate, and 1–2% w/w silicon dioxide. The blend is mixed in a bin blender for 10–14 min at 70–80% fill, then compressed on a 16-station rotary tablet press targeting hardness 80–120 N and friability below 1.0%. Dissolution is controlled by USP <711> apparatus II at 50 rpm in 900 mL purified water, with acceptance of 80% released at 45 min. Microbiological quality follows Ph. Eur. 5.1.4, and elemental impurities are monitored under ICH Q3D. Tablets are film-coated with an aqueous hydroxypropyl methylcellulose system; coating pan inlet air is kept at 65–70°C to avoid moisture uptake. The terminal products are scored tablets of 100 mg or 250 mg labeled extract content and hard gelatin capsules of 50–150 mg fill weight. A production-scale limitation appears when ambient relative humidity exceeds 60%; the uncoated cores absorb moisture above 5.0% w/w within 30 min, causing sticking and picking on punch faces and a rapid increase in ejection force. Therefore, compression suites are maintained at 40–50% RH and 21–25°C, and tablets are immediately transferred to sealed desiccant-lined containers.
In ruminant practice, Jin Qiaomai Tablets Veterinary Grade API is converted into a homogeneous oral drench suspension by high-shear dispersion of 10.0% w/v active fraction into purified water containing 0.3% w/v xanthan gum and 0.2% w/v sodium alginate, with 0.1% w/v sodium benzoate as preservative and pH adjusted to 5.0–5.5 with citric acid. The slurry is mixed for 15 min at 3,000 rpm in a bottom-discharge homogenizer, then refined through a 150 µm colloid mill to reduce particle size; the milled suspension is filled into 100 mL, 250 mL, and 500 mL high-density polyethylene bottles. Quality limits include a sedimentation volume ratio not less than 0.90 after 24 h as determined by the graduated cylinder method and redispersibility within 15 s of manual shaking. Microbiological acceptance follows Ph. Eur. 5.1.4 for non-sterile oral products, with total aerobic microbial count not exceeding 10² CFU/g and bile-tolerant Gram-negative bacteria absent in 1 g. The formulation ratio is bounded by the extract’s negative impact on yield value: at 15% w/v active fraction, the suspension becomes difficult to pour without yield stress below 5 Pa, and at 5% w/v the label dose requires an impractically large volume for adult cattle. Terminal finished product type is a ready-to-use oral drench suspension. Incompatibility is documented with antacid salt suspensions containing magnesium hydroxide or aluminum hydroxide; polyphenol-metal binding accelerates aggregation and forms a non-redispersible sediment within 4 h. Therefore, concurrent administration through the same drench line is avoided, and farm holding tanks are flushed with 20 L potable water between products.
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Jin Qiaomai Tablets Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is released as a milled botanical active substance intended solely for further processing into veterinary finished dosage forms. The model designation is the full commercial phrase itself; the certificate of analysis does not carry an additional numeric grade suffix. The route list is a documented dosage-form compatibility statement rather than seven separate API grades. The product is not authorised for direct administration to animals. The powder is pale fawn to light brown with a characteristic odour and is supplied in double polyethylene liners inside aluminium-laminated drums. Release testing includes appearance, identity by high-performance liquid chromatography, loss on drying, total ash, acid-insoluble ash, heavy metals, total aerobic microbial count, combined yeasts and moulds, and marker content. Because the substance is a multi-constituent botanical preparation, assay is expressed as marker content rather than as a single chemical entity. Compared with unconcentrated Jin Qiaomai plant powder, the veterinary grade API is milled to a controlled particle size distribution and released against microbial limits suitable for oral veterinary dosage forms; injectable suitability is achieved only after downstream sterile processing.
Regulatory submissions for finished products containing this API should align with Veterinary International Conference on Harmonisation quality guidance. Analytical procedure validation follows VICH GL2 and VICH GL49; stability testing follows VICH GL3 and VICH GL18. A harmonised Ph. Eur. or USP monograph specific to Jin Qiaomai is not currently listed, so the manufacturer’s monograph and active substance master file remain the primary control documents. Residual solvent testing is referenced to Ph. Eur. 2.4.24 and USP <467>. Heavy metals are controlled by Ph. Eur. 2.4.8 or USP <231> depending on the destination submission. For oral dosage forms, microbial enumeration follows USP <61> and USP <62> or Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13. The absence of Escherichia coli and Salmonella in 25 g is confirmed. For injectable route development, bacterial endotoxin testing is performed according to Ph. Eur. 2.6.14 or USP <85>; the bulk API is not sterile and is not considered injectable without downstream sterilisation.
Particle size distribution is measured by laser diffraction according to USP <429> or Ph. Eur. 2.9.31. The milled powder is intended to produce acceptable blend uniformity in dry powders and premixes, but direct tablet compression may require a glidant because interparticle cohesion increases as the D50 falls. Each lot reports D10, D50, and D90 values on the certificate of analysis. When D90 exceeds the target fill head clearance, a cone mill equipped with a 600 µm rasp screen is typical; overmilling is not recommended because charged fines may reduce bulk density and increase dusting during transfer.
Powder flow acceptance for capsules and direct compression blends is based on the compressibility index and Hausner ratio. A compressibility index below 25% and a Hausner ratio below 1.25 are common pass criteria before press speed is increased beyond pilot scale. The material is not free-flowing in all humidity conditions; storage above 60% relative humidity increases moisture uptake and may reduce hopper discharge consistency. In dry-blend operations, a 0.5% w/w colloidal silicon dioxide addition and a 1.0% w/w magnesium stearate addition are common starting points, but the exact ratio should be established through a formulation design study. Stratified blend sampling at the start, middle, and end of the run is required because botanical powders with a wide particle size span may segregate. Published data for this specific configuration is limited; therefore, the stated lubricant level should not be transferred to another product without blend uniformity confirmation.
Tablet manufacture using this API can be performed by direct compression or wet granulation. For direct compression, the API is pre-blended with a directly compressible filler before lubricant addition; the filler-to-API ratio should be selected so that blend uniformity passes USP <905> or Ph. Eur. 2.9.40. Wet granulation in a low-shear planetary mixer or a high-shear granulator with impeller speed not exceeding 400 rpm is preferred when the formulation is moisture-sensitive. Granules are dried to a moisture content below 5.0%; residual moisture above 6.0% increases the risk of picking and sticking during compression. For capsule filling, the powder is pre-blended with a directly compressible carrier at a ratio of at least 70:30 carrier-to-API before final lubrication. Capsule fill weight is determined by marker assay rather than by bulk powder weight alone. Excessive dwell time at high compaction force should be avoided because the botanical material can laminate when tablet hardness exceeds the development-set limit.
On production-scale twin-shell blenders, the main bottleneck is electrostatic charge build-up in low-humidity conditions below 30% relative humidity. Static charge causes API fines to adhere to the vessel wall and produces low assay values at the top sampling ports. Grounding the blender and maintaining room relative humidity between 40% and 55% reduces this effect. In high-shear wet granulation, the water or binder solution addition should be controlled by power consumption rather than by time alone; a sudden power drop can indicate overwetting and leads to lump formation. The wet mass endpoint is correlated with probe power draw to avoid batch-to-batch variation.
Sterile injectable presentations require a route-specific development sequence. The bulk API is not sterile and may contain bacterial endotoxins. After dissolution in Water for Injection, the bulk solution is prefiltered through a 0.45 µm membrane and sterilised by passage through a 0.22 µm membrane; terminal heat sterilisation at 121.1 °C for 15 min is acceptable only after marker recovery has been demonstrated. The pH of a 1% w/v aqueous dispersion commonly falls between 5.0 and 7.0; the finished solution should be buffered to the target animal species’ physiological range and adjusted for isotonicity with sodium chloride or dextrose. Precipitation after dilution with 0.9% w/v sodium chloride or 5% w/v dextrose indicates vehicle incompatibility. High-shear mixing during solution preparation is not recommended because foam generation reduces filter throughput. Endotoxin reduction is validated by a low-level challenge study showing a minimum 3-log reduction across the sterilising filter train. Particulate matter is controlled according to USP <788> or Ph. Eur. 2.9.19.
Premix and granule formulations depend on a dry carrier to offset poor powder flow. Corncob meal, lactose monohydrate, dextrose, or spray-dried rice hulls are used after drying to a moisture content below 8.0%. When the API inclusion rate is below 5.0% w/w, geometric dilution is required. The first dilution step should not exceed a 1:10 mass ratio; each subsequent step is mixed for at least 15 min in a V-blender or double-cone blender at 25 rpm. Blend uniformity is assessed by near-infrared reflectance where a validated calibration exists; otherwise reverse-phase HPLC is used on 10 sampling points. Granules for oral solution or in-feed medication are prepared by wet granulation and dried in a fluid-bed dryer with inlet air temperature not exceeding 60 °C to limit marker degradation. Final granule moisture should remain below 5.0%; moisture above 7.0% leads to caking and dispensing variability.
The marker compound in botanical APIs can degrade when terminal sterilisation is used; therefore, thermal recovery is measured by comparing HPLC peak area before and after a laboratory-scale autoclave cycle at 121.1 °C for 15 min. A recovery below 95% triggers a switch to sterile filtration only. Solution discolouration at pH above 9 indicates deprotonation or oxidation; buffering to pH 4.5–6.5 may improve stability. The headspace should be replaced with nitrogen if the solution shows colour shift during storage at 25 °C for 48 h. Because published data for this specific configuration is limited, the pH and thermal limits should be verified on the actual commercial batch before release of an injectable finished product.
The main differences are route-specific quality, particle size consistency, and residual solvent documentation. Unmilled Jin Qiaomai plant powder may carry a total aerobic microbial count above the oral veterinary limit and is not suitable for injectable processing. Technical-grade extracts may contain higher residual ethanol or methanol levels, whereas the veterinary grade is released against Ph. Eur. 2.4.24 or USP <467> limits. The milled particle size distribution is controlled to reduce segregation in premixes and capsules, while unprocessed botanical material shows wide sieve fractions that make tablet weight control difficult. Compared with synthetic single-entity veterinary APIs, such as enrofloxacin or amoxicillin trihydrate, this botanical product is assayed as a marker constituent and therefore requires tighter extractable and batch-to-batch variability controls. The route list includes injections only where bacterial endotoxins, particulate matter, and sterility are addressed after dissolution; the bulk API alone is not injectable.
| Parameter | Jin Qiaomai Veterinary API | Unmilled botanical powder | Technical-grade extract |
|---|---|---|---|
| Microbial release | Oral limit per USP <61> / Ph. Eur. 2.6.12 | Not controlled | Variable |
| Residual solvent documentation | Released per Ph. Eur. 2.4.24 or USP <467> | Not tested | Higher residual solvent risk |
| Particle size | Controlled D90 by laser diffraction | Wide sieve fractions | Variable |
| Injectable suitability | Only after sterile filtration or terminal sterilisation | No | No |
| Batch documentation | Active substance master file, certificate of analysis | Limited | Limited |
Storage of the bulk API is specified at 25 °C and 60% relative humidity in airtight containers. Repeated opening at relative humidity above 60% for more than 72 h can increase moisture absorption and reduce powder flow; pre-drying at 40 °C in a forced-air oven is recommended before use when the material has been exposed to uncontrolled humidity. Avoid direct sunlight, strong oxidising agents, and proximity to volatile organic solvents because the product may sorb odours. Accelerated stability testing is conducted according to VICH GL18 at 40 °C and 75% relative humidity for 6 months; long-term data are collected at 25 °C and 60% relative humidity or 30 °C and 65% relative humidity depending on the target region. Because published stability data for every route configuration is limited, bracketing and matrixing designs are recommended for finished-product stability studies.
Final dosage form usage is determined by the authorised veterinary medicinal product. Oral powders and premixes are incorporated into feed or drinking water according to the finished product label. Injectable solutions are for veterinary parenteral use after sterile filtration or terminal sterilisation; capsules and tablets are for oral administration. The manufacturer or compounder is responsible for verifying the active substance master file, certificate of analysis, and site GMP status before use.
| Quality attribute | Analytical reference | Route-specific acceptance basis | Applicable dosage forms |
|---|---|---|---|
| Identity and marker content | HPLC system suitability per USP <621> / VICH GL2 | Retention time and peak area reproducibility; RSD ≤ 2.0% | All routes |
| Loss on drying | Ph. Eur. 2.2.32 | Below 8.0% for oral powder; below 5.0% for tablet granulation | Tablets, capsules, powders, granules, premix |
| Heavy metals | Ph. Eur. 2.4.8 / USP <231> | Must pass compendial limits | All routes |
| Total aerobic microbial count | USP <61> / Ph. Eur. 2.6.12 | ≤ 10³ cfu/g for oral herbal preparations | Oral routes |
| Total yeasts and moulds | USP <61> / Ph. Eur. 2.6.12 | ≤ 10² cfu/g | Oral routes |
| E. coli / Salmonella | USP <62> / Ph. Eur. 2.6.13 | Absence in 25 g | Oral routes |
| Bacterial endotoxin | Ph. Eur. 2.6.14 / USP <85> | Route-specific limit | Injection only after sterile processing |
| Particle size D90 | USP <429> / Ph. Eur. 2.9.31 | Lot-specific, reported on certificate of analysis | All routes |
