| HS Code | 653655 |
| Product Name | Kushen Diy u Powder Veterinary Grade API |
| Api Type | Veterinary botanical active pharmaceutical ingredient |
| Botanical Source | Sophora flavescens root (Kushen) and Sanguisorba officinalis root (Diyu) |
| Physical Appearance | Fine brownish-yellow to brown powder with slight herbal odor |
| Ph Value | 4.0 to 7.0 in a 1% aqueous dispersion |
| Solubility | Soluble in diluted ethanol and warm water; partially soluble in cold water |
| Microbial Limits | Total bacterial count below 1000 CFU/g; negative for Salmonella and Escherichia coli |
| Storage Conditions | Store sealed in a cool, dry, well-ventilated place, protected from light and moisture |
| Shelf Life | 24 months under proper storage conditions |
As an accredited Kushen Diy u 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 | Kushen Diy u Powder Veterinary Grade API is packaged in 25 kg fiber drums with double polyethylene liners for safe transport. |
| Container Loading (20′ FCL) | 20′ FCL: Kushen Diy u Powder veterinary API loaded in sealed containers, palletized, secured, documented, ready for safe transit. |
| Shipping | Shipment is made in sealed, moisture-resistant containers suitable for veterinary API powders. Temperature-controlled, dry transport protects stability. All packages are labeled with proper hazard and handling documentation, complying with international shipping regulations. Delivery options include air and sea freight, with secure tracking for full chain-of-custody until final destination. |
| Storage | Store Kushen Diy u Powder Veterinary Grade API in tightly sealed original containers in a cool, dry, well-ventilated area. Protect from direct sunlight, heat, moisture, and strong oxidizing agents. Keep away from foodstuffs and animal feed. Maintain temperature below 25°C. Once opened, reseal immediately. Under recommended conditions, shelf life is as labeled. Use within manufacturer’s expiry date. |
| Shelf Life | Shelf life: 24 months when stored unopened in a cool, dry, well-ventilated area, protected from light and moisture. |
The Kushen Diyu powder contains matrine (C15H24N2O) and oxymatrine (C15H24N2O2) from Sophora flavescens alongside ellagitannin fractions from Sanguisorba officinalis. Tannin-alkaloid complexation is observed in aqueous granulation fluids above pH 6.0. The resulting insoluble aggregates reduce content uniformity in direct compression. Wet granulation with an ethanolic binder solution (40–60% v/v) suppresses tannin ionization. A high-shear mixer granulator operating at 120–180 rpm impeller speed with a 5–8 minute kneading phase produces dense granules. Granule loss on drying is maintained at 2.0–3.5% w/w before compression. Microcrystalline cellulose PH102 is added at 15–25 wt% as a compaction aid. Sodium starch glycolate at 4–6 wt% provides disintegration. Magnesium stearate is limited to 0.5–1.0 wt%. Higher levels delay disintegration beyond the 30-minute limit for uncoated veterinary tablets specified in USP <701>. Compression force is set at 8–15 kN on a rotary tablet press with 9.5 mm round punches. Hardness is controlled at 50–80 N. Friability remains below 1.0%. The finished tablet mass is 300–500 mg for swine and poultry dosing. Film coating with hydroxypropylmethylcellulose (6 cP) masks the bitter alkaloid taste. The coating process uses a pan coater with inlet air temperature of 55–65°C. Coating thickness is 3–5% weight gain. Published dissolution data for this specific two-herb combination is limited. A basket apparatus at 100 rpm in 0.1 M HCl (900 mL) provides acceptable batch release conditioning. The matrine content is quantified by HPLC against a reference standard. Assay limits follow the API certificate of analysis. Tablets are packaged in aluminum foil blister or HDPE containers with desiccant. Moisture ingress above RH 60% causes granule caking and hardness increase on storage.
After depyrogenation of the raw powder, sterile injection formulation proceeds via aqueous extraction. The powder is dissolved in Water for Injection at 20–40 g/L total solids. Tannin fractions are partially removed by refrigerated settlement at 2–8°C for 12–24 hours. The supernatant is filtered through a 0.45 μm membrane. pH is adjusted to 5.5–6.5 with 0.1 M hydrochloric acid or sodium hydroxide. Sodium chloride is added to achieve 280–320 mOsm/kg osmolarity. Terminal sterilization at 121°C for 15 minutes is standard for heat-stable alkaloid salts. Matrine hydrochloride resists degradation at this cycle. Oxymatrine undergoes partial hydrolysis above pH 7.0. The final solution is filled into 10 mL or 20 mL neutral borosilicate glass vials under ISO 14644-1 Class 5 (Grade A) conditions. Nitrogen overlay reduces oxidative browning of tannin residues. The finished injectable is tested for sterility per USP <71> or equivalent CVP method. Bacterial endotoxin testing follows USP <85> with limits calculated per target species. Light-resistant secondary packaging prevents photodegradation of flavone glycosides. Storage at 2–8°C extends shelf life when tannin content exceeds 1.0 g/L. Precipitate formation during storage indicates tannin-alkaloid flocculation and requires reformulation.
Hard gelatin capsule production with the Kushen Diyu API presents flow and hygroscopicity challenges. The native powder bulk density ranges from 0.55 to 0.75 g/mL. Tapped density approaches 0.85–0.95 g/mL. Carr's index exceeds 25 without granulation. Dry granulation by slugging or roller compaction improves flow. Roller compaction at 30–50 bar with 2.0 mm screen milling produces granules with angle of repose below 35°. Lactose monohydrate 200 mesh is added at 20–30 wt% as a diluent. Silicified microcrystalline cellulose at 10–15 wt% reduces moisture uptake. Capsule size 0 or 1 is selected for 250–500 mg fill weights. A semi-automatic capsule filling machine with dosing disc 0.3–0.6 mL is used. Pin indent dosing is avoided due to powder adhesion to stainless steel. Dissolution testing follows a two-point basket method per USP <711>. At 15 minutes, not less than 70% of labeled matrine is released in 0.1 M HCl. Tannin-alkaloid complexes formed in acidic media can slow release from the capsule matrix. The gelatin shell itself degrades in hot humid conditions. Storage below 25°C and below RH 45% is mandatory for tropical distribution. Blister packaging with PVDC-coated PVC film provides the required moisture barrier. Capsule content uniformity requires validation per USP <905> criteria adapted for the dosage form. Batch-to-batch variance in tannin content alters the dissolution curve at the 45-minute time point. The API supplier certificate must report total tannin content by UV at 280 nm.
For drinking water administration, the sulfated alkaloid fraction governs solubility behavior. Matrine sulfate is freely soluble in water at 25°C. The raw Kushen Diyu powder contains some water-insoluble tannin-protein complexes. These are removed by hot water extraction and spray drying during API manufacture. The powder formulation uses dextrose monohydrate as the primary carrier at 50–80 wt%. Sodium saccharin at 0.5–1.5 wt% improves palatability for swine. Citric acid anhydrous at 2–4 wt% chelates heavy metals and stabilizes alkaloid salts in solution. Sodium metabisulfite at 0.1–0.3 wt% acts as an antioxidant. The blended powder is milled through a 40-mesh screen. Mixing in a double-ribbon blender for 15–20 minutes achieves a relative standard deviation below 5% for matrine content. The final product dissolves within 2 minutes in water at 20°C under mild agitation. Reconstituted solution is stable for 24 hours at room temperature if protected from light. Dosing via a proportional medicator at 1–5% stock solution provides 100–300 mg of total solids per liter of drinking water. Palatability constraints limit upper solution concentrations because the astringent tannin fraction reduces voluntary intake in swine. Published quantitative intake-suppression data for this specific two-herb combination is limited. The powder is packaged in laminated foil pouches of 100 g, 500 g, and 1 kg. Moisture content above 5.0% causes caking during storage. Desiccant sachets are inserted in bulk containers.
| Dosage Form | Critical Parameter | Working Range | Test Method/Standard |
|---|---|---|---|
| Tablets | Granule loss on drying | 2.0–3.5% w/w | USP <731> loss on drying |
| Injectables | Terminal sterilization cycle | 121°C for 15 min | USP <1229.1> steam sterilization, overkill approach |
| Capsules | Dissolution release at 15 min | ≥70% labeled matrine | USP <711> apparatus 1, 100 rpm |
| Water-soluble powder | Solution clarity after 2 min mixing | No visible sediment | In-process visual inspection |
| Granules | Product temperature during fluid-bed drying | <40°C | Calibrated thermocouple probe |
| Premix | Blend uniformity RSD (10-point) | <8% | Validated in-process HPLC method |
| Oral solution | pH stability window | 4.5–5.5 | EP 2.2.3 potentiometric pH |
Because the native matrine alkaloid melts at 76–78°C, fluid-bed granulation demands tight thermal control. The Kushen Diyu API is pre-mixed with sucrose or glucose at 30–50 wt%. Binder solution of PVP K30 at 5–10% w/w in 50% ethanol is sprayed from a top-spray nozzle. Inlet air temperature is maintained at 45–55°C. Product temperature stays below 40°C to prevent surface melting of alkaloid crystals. The granulation endpoint is reached when granules pass a 20-mesh screen and retain less than 15% fines below 80 mesh. Drying continues until loss on drying falls below 3.0%. Granule flow drops below 22 seconds per 100 g using a funnel test. The finished granules are filled into sachets of 5 g or 10 g. Each 1 g of granules contains not less than 0.5 g of the herbal extract. The oral dose for piglets is 1–2 g per 10 kg body weight twice daily for 5–7 days. Palatability is the main formulation constraint. The astringent taste of Diyu tannins is partially masked by concurrent coating with maltodextrin DE 10–15. Pan coating of granules at 2–3% weight gain with ethylcellulose provides taste masking without delaying release. The coating solvent is ethanol or isopropanol. Residual solvent content is tested by GC headspace. The limit follows ICH Q3C for Class 3 solvents.
During transfer from bulk bags to batch mixers, premix segregation is governed by carrier particle geometry. Corn cob fraction 20–40 mesh is used at 60–80 wt%. The API particle size is typically below 200 μm. The difference in particle size and density creates segregation risk. Mineral oil at 0.5–1.0 wt% is sprayed onto the carrier first. The oil film increases surface adhesion of the herbal dust. Mixing is performed in a double-cone or ribbon blender for 20 minutes. Sampling at 10 points yields relative standard deviation below 8% for matrine content. Segregation during bulk bag discharge is tested by collecting samples at the beginning, middle, and end of the flow. The premix is incorporated into finished feed at 2–10 kg per metric ton. Equipment qualification follows 21 CFR 225.30 for medicated feed mixing. The active alkaloids are stable in pelleted feed processed at 70–80°C for 3–5 minutes. Steam conditioning at 85°C for 30 seconds does not degrade matrine. Pellet durability index exceeds 90 when the premix is included at the 5 kg/ton rate. The final feed is assayed by LC-MS/MS for matrine and oxymatrine. Recovery from feed matrix is 85–95% using a methanol-water extraction with 0.1% formic acid. The premix is packaged in multi-wall paper bags with a polyethylene inner liner. Storage at below 25°C and less than RH 60% preserves activity for 24 months. Iron-based carriers are avoided. Tannins from Diyu chelate ferric ions and darken the premix.
In a co-solvent system of propylene glycol, glycerin, and purified water at a 1:2:7 ratio, the full-spectrum extract is solubilized. The propylene glycol fraction at 10–15% v/v solubilizes lipophilic alkaloids including sophocarpine. Glycerin at 20–30% v/v provides viscosity and reduces sedimentation. The pH is adjusted to 4.5–5.5 with citric acid. Potassium sorbate at 0.1–0.2% w/v and sodium benzoate at 0.1% w/v provide preservation. Microbiological challenge testing follows EP 5.1.3. The solution is filled into amber PET bottles of 100 mL, 250 mL, and 500 mL. A calibrated measuring cup or dosing syringe is included. The oral dose for poultry is 0.5–1.0 mL per liter of drinking water for 3–5 days. For calves and lambs, 5–10 mL per 50 kg body weight is administered by drench. Stability of the solution is challenged at 40°C/75% RH for 6 months per ICH Q1A(R2) accelerated conditions. Tannin precipitation appears as dark sediment within the challenge period. The specification allows sediment below 0.5% w/v after shaking. Published stability data for this specific multi-herb extract in the co-solvent system is limited. The solution is not compatible with aluminum closures. Tannins corrode aluminum foil and release aluminum ions into the liquid.
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Among veterinary active pharmaceutical ingredients derived from multi-component botanical sources, the product designated Kushen Diy u Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied as a dry powder for incorporation into oral and injectable dosage forms. The product designation contains no manufacturer-specific model number; the term “Veterinary Grade API” therefore operates as the grade and model descriptor, and any batch-specific model or lot code must be drawn from the certificate of analysis. Botanical attribution to Kushen (Sophora flavescens) and Diyu (Sanguisorba officinalis) is common in trade documentation, but the exact plant parts, extraction solvent, drying method, and excipient carrier are not defined in the product string and must be confirmed with the supplier under a vendor qualification program. Because the material is an active pharmaceutical ingredient and not a finished veterinary medicinal product, no target-species indications, dosage schedules, or withdrawal periods are assigned by the designation itself; these parameters are established only in the finished product authorization.
Release parameters for comparable veterinary botanical powders typically address appearance, identification, loss on drying, total ash, acid-insoluble ash, heavy metals, microbial enumeration, and residual solvents. For this material, numerical acceptance criteria are not assignable from the product string alone. Loss on drying is determined by USP <731>; microbiological examination follows USP <61> and USP <62>; heavy metals may be measured by USP <231> or inductively coupled plasma-mass spectrometry; and residual solvents are assessed by USP <467> when organic solvents are used during extraction. If the powder is intended for sterile injectable processing, bacterial endotoxin control under USP <85>, particulate matter control under USP <788>, and sterility testing under USP <71> become relevant. Published data for this specific configuration are limited; therefore, the supplier’s certificate of analysis, stability data, and method validation report are the controlling documents for release.
The as-supplied powder should not be considered sterile, depyrogenated, or suitable for direct injection. For injectable veterinary products, the powder must be dissolved or dispersed in Water for Injection, clarified, depyrogenated, and sterilized by a validated method. If the active constituents are thermolabile, terminal steam sterilization may be incompatible; in such cases, aseptic filtration through 0.22 µm membrane filters is used, provided that filter compatibility and adsorption of polyphenolic or tannin fractions are assessed. Bacterial endotoxin limits are established according to USP <85> and are product-specific; the limit is calculated from the maximum dose administered to the target species and route, not transferred from a tablet monograph. Particulate matter must meet USP <788> for injectable preparations, and sterility testing follows USP <71>. Process water, buffer salts, and tonicity agents must be of injectable grade. If membrane adsorption or colloidal loading is observed, a depth filter or 0.45 µm pre-filtration step may be required before sterile filtration. Anion-exchange depyrogenation of the bulk solution should be evaluated with recovery studies because positively charged alkaloid fractions may bind to the resin and reduce the active marker content.
Dry blending of the powder into tablet and capsule excipient systems requires characterization of particle-size distribution, bulk density, tapped density, and flow. Bulk and tapped density are assessed by USP <616>; particle-size distribution is measured by USP <786> or laser diffraction. If direct compression is selected, a high active load may produce weight variation or sticking because of the extract matrix. Wet granulation or roller compaction is then introduced. For hard capsules, the milled API is blended with lactose monohydrate or microcrystalline cellulose and a glidant such as colloidal silicon dioxide; fill weight and content uniformity are verified according to USP <905>. The powder may be electrostatic at low process humidity, which can interfere with capsule plug formation on automatic capsule fillers. If environmental relative humidity exceeds 60% during tableting, the API should be pre-dried or the suite humidity controlled, because moisture uptake reduces flow and promotes sticking during compression.
Wet granulation introduces water and binder that can alter the chemical stability of multi-component botanical powders. In high-shear granulators, impeller torque and power draw are used to detect granulation end-point; the water amount is typically added at a rate slow enough to avoid overwetting of hygroscopic fractions. Drying in a fluid-bed dryer or tray dryer is then performed at product-specific inlet-air temperatures. Conservative development often evaluates drying at or below 60 °C until product-specific thermal stability data establish a higher safe operating range. The dried granule is milled and sieved to a defined particle-size distribution, with oversized granules recycled only after verifying that repeated compaction does not induce segregation or alter dissolution. Because botanical tannins and polyhydroxylated constituents can interact with povidone and starch, binder selection should be evaluated in a small-scale formulation study measuring tablet hardness, disintegration, and dissolution. If the API contains residual acidic or alkaloidal fractions, granulation fluid pH may require buffering to avoid hydrolysis or precipitation during drying.
Batch-to-batch variability in plant raw material moisture and extractable solids can shift the wet massing endpoint; therefore, the amount of granulating fluid is adjusted based on the API lot loss on drying. Direct compression is generally feasible only when the lot is dry, free-flowing, and contains a low extractable resin fraction. If the powder is compressed as a high-dose tablet, pre-drying at low relative humidity and the use of colloidal silicon dioxide may be necessary. Tablets should be monitored for capping, lamination, and punch filming; these failures are often related to residual moisture, binder type, or over-lubrication. Avoid combination with strong oxidizing agents unless compatibility has been demonstrated, because polyphenolic fractions may undergo oxidation and discoloration.
Compared with purified matrine or oxymatrine isolates, this powder may retain the broader extract matrix, which can influence solubility, hygroscopicity, color, and analytical interference. High-performance liquid chromatographic assay of a single marker may not reflect the total active fraction; for regulatory control, multiple markers or a chromatographic fingerprint should be considered. Compared with feed-grade botanical powders, the veterinary-grade API is expected to meet tighter microbial enumeration, heavy metal, and residual solvent criteria, but this expectation must be verified rather than assumed. Unlike a synthetic single-compound API, the multi-constituent botanical powder introduces natural variability in constituent ratios; this variability must be managed through controlled raw-plant sourcing, extraction process reproducibility, and batch-to-batch blending. The difference from other products rests on intended use: feed-grade material may be acceptable for oral premix but not for injectable or solution formulations, while single-marker extracts may be appropriate for standardization but may not replicate the full extract matrix.
Oral solutions and drinking-water preparations require solubility assessment of the active fraction. The powder is not necessarily fully soluble; suspended or colloidal particles may form and cause sedimentation in dosing lines. If the product is compounded into a solution, the use of pH modifiers and cosolvents should be evaluated according to target-species palatability and stability. Precipitation at acidic pH or after dilution into hard water can result in non-uniform dose delivery through nipple water systems; therefore, solution formulation studies should include pH and hard-water challenge testing. For medicated premix, the API is blended onto a carrier such as lactose monohydrate or calcium carbonate at a defined inclusion rate, and homogeneity must be demonstrated under intermittent mixing. If the premix is used in medicated feed, 21 CFR 225 current good manufacturing practice requirements may apply to the medicated feed manufacturing facility.
Release of the powder requires a certificate of analysis that extends beyond visual inspection. A control strategy for a veterinary-grade botanical API should include identity, purity, microbial safety, and physical attributes. The following matrix is not a product-specific specification but a framework of compendial methods commonly applied to multi-constituent veterinary botanical powders. Each acceptance criterion must be assigned by the manufacturer or the dosage-form sponsor and justified by process capability and target-species safety.
| Attribute | Method | Role in Release |
|---|---|---|
| Identification | HPLC or TLC | Confirms botanical marker profile |
| Loss on drying | USP <731> | Controls moisture content and drying consistency |
| Microbial enumeration | USP <61> / USP <62> | Limits total aerobic microbial count, yeast, mold, and specified organisms |
| Heavy metals | USP <231> or ICP-MS | Limits lead, arsenic, cadmium, and mercury |
| Residual solvents | USP <467> | Detects residual extraction solvents |
| Bulk and tapped density | USP <616> | Supports capsule filling and tableting operation |
| Particle-size distribution | USP <786> or laser diffraction | Guides blending, flow, and dissolution performance |
| Bacterial endotoxins | USP <85> | Required if the API is intended for injectable preparation |
| Sterility | USP <71> | Required only if the API carries a sterile claim |
For injectable solution development, forced degradation studies across a pH range of 3.0 to 9.0 are recommended to identify precipitation or degradation boundaries. Solution clarity and particulate matter are tested according to USP <788>. If the solution is intended for small-volume parenteral administration, the endotoxin limit is derived from the maximum dose and is not a fixed value transferred from other species or products. Sterile filtration validation should include filter compatibility, extractables, and bacterial retention; terminal sterilization may require autoclave mapping and thermal stability data. The use of buffering salts, tonicity agents, or stabilizers must be justified by batch data and finished-product stability, not assumed from use in nonsterile oral forms.
The powder’s multi-dosage-form designation does not guarantee that every lot will perform identically in all routes. Injectable processing imposes stricter limits on bioburden, endotoxin, particulate matter, and chemical purity than tablet or capsule processing. A lot released for oral solid dosage use may still require additional purification or depyrogenation before injectable compounding. Conversely, a lot prepared to injectable-grade specifications may be used in oral powders or granules only if the higher processing cost is accepted and the formulation does not rely on insoluble botanical carriers. The manufacturer’s CoA should identify the intended route or specify the maximum bioburden and endotoxin burden for the lot.
