| HS Code | 815474 |
| Product Name | Kushen Injection Veterinary Grade API |
| Source | Sophora flavescens root extract |
| Active Ingredients | Matrine and Oxymatrine |
| Physical Form | Crystalline powder for API compounding |
| Solubility | Soluble in water |
| Ph Range | 4.0–6.0 in aqueous solution |
| Assay Content | ≥98% combined matrine and oxymatrine |
| Veterinary Indications | Anti-inflammatory, antiviral, and antipyretic use for livestock and poultry |
| Dosage Form Compatibility | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Storage Conditions | Store in a cool, dry, well-ventilated area protected from light |
| Shelf Life | 24 months from date of manufacture |
| Regulatory Classification | Veterinary-grade active pharmaceutical ingredient, non-GMO |
As an accredited Kushen Injection 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 | Supplied in sealed, moisture-proof 25 kg drums, preserving purity and stability for veterinary tablet, injection, and powder formulations. |
| Container Loading (20′ FCL) | One 20′ FCL container loading of Kushen Injection veterinary-grade API, securely packed in sealed drums on pallets for safe transport. |
| Shipping | Shipments of Kushen Injection Veterinary Grade API are securely packaged in sealed, moisture-proof containers to maintain purity and stability. Temperature-controlled shipping is used for injections and solutions; powders, granules, tablets, capsules, and premix ship at ambient conditions. Full documentation, certificates, and traceability are provided for compliance. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature, protected from light and moisture. Keep container tightly sealed when not in use. Avoid exposure to direct sunlight, high heat, or freezing. Ensure compatibility with approved packaging for veterinary use. |
| Shelf Life | Shelf life is typically 24 months when stored in a cool, dry, well-ventilated area, protected from light and moisture. |
Premix production for broiler and layer operations begins with a sizing check: the API powder frequently shows a bimodal particle distribution with a fine fraction below 75 µm and a coarse fraction above 150 µm, while the ground corn or rice hull carrier is typically 600–1,000 µm. Direct blending of these fractions causes segregation during transfer. To counter this, the API is pre-blended with precipitated silica or sodium sulphate at a 1:9 w/w ratio in a low-shear ribbon mixer operating at 20 rpm for 10–15 min; the silica acts as a flow aid and moisture scavenger. The intermediate premix is then let down into a carrier to a target total alkaloid concentration of 5–10 g/kg as matrine. Loss on drying is controlled at ≤5.0% to avoid cohesion in the mixer, and the final blend is packed in 25 kg polyethylene-lined bags without prior compaction. Homogeneity acceptance uses 10 thief samples drawn from the V-blender after the mixer has discharged; the HPLC assay must fall between 90.0% and 110.0% of label claim, and the relative standard deviation across the 10 sample points must be ≤5.0%. Cross-contamination in a multi-species feed mill is managed by running a 1% carryover flush of ground limestone after the medicated premix; unmedicated feed following the flush is assayed to confirm total alkaloid residues below the legal threshold for the destination market. The final premix is intended for incorporation into complete feed at 2–5 kg per tonne, but the exact inclusion rate is set by the registered veterinary medicinal product licence, not by the API vendor. Process bottlenecks on production lines include dead zones behind the ribbon agitator and static adhesion to stainless steel surfaces when ambient relative humidity exceeds 60%. In such conditions, the mixer is fitted with an anti-static grounding kit and the baghouse is inspected after each batch. Table 1 lists the release methods applied to this dosage form.
| Control parameter | Method / standard | Acceptance limit |
|---|---|---|
| Total alkaloid content as matrine | HPLC, in-house validated method | 90.0–110.0% of label claim |
| Loss on drying | Ph. Eur. 2.2.32 | ≤5.0% for premix granules |
| Blend uniformity | 10-point sampling, HPLC | RSD ≤5.0% |
| Particle size Dv90 | Laser diffraction | 250–425 µm |
| Microbial enumeration | USP <61> | TAMC ≤10³ CFU/g, TYMC ≤10² CFU/g |
| Specified organisms | USP <62> | Salmonella absent in 25 g, E. coli absent in 1 g |
The water-soluble powder presentation is formulated as a free-flowing granule by dissolving the API together with citric acid, lactose monohydrate, and a low-foam wetting agent in purified water, followed by spray drying at an inlet temperature of 140–160°C and outlet temperature of 70–85°C. The citric acid-to-API ratio is typically 2:1 to 5:1 to ensure the final medicated drinking water remains below pH 4.5, where the alkaloidal nitrogen stays protonated and precipitation is reduced. Water hardness is a critical operational boundary: when total hardness exceeds 400 mg/L as CaCO₃, calcium and magnesium salts can form insoluble alkaloid complexes that accumulate in nipple drinker lines; field installations with hard bore water require an inline acid dosing module or a pre-softening step. The recommended stock solution concentration at the farm is 1,000 ppm total alkaloid, then diluted to the therapeutic concentration according to the approved label; mixing-tank shear imposed by a 1,400 rpm propeller for 20 min dissolves the granule without denaturing the extract, while longer mixing beyond 60 min may entrain air and increase oxidation. The final solution is filtered through a 100–250 µm inline mesh screen to remove undissolved carrier. Compliance for this presentation requires microbial limits per USP <61> and USP <62>; because it is administered via drinking water, the batch must be free of Salmonella in 25 g and E. coli in 1 g. The main production-scale failure mode is not chemical degradation but palatability rejection: high concentrations above 2,000 ppm total alkaloid reduce water intake in swine, so farms must monitor daily water consumption during treatment. Published data for this specific configuration is limited because drinking-water formulations are registered separately by each competent authority; the API formulator must therefore qualify the granule using the target market’s field dilution water, not only standard laboratory water. Table 2 compares aqueous process parameters across the three liquid-compatible presentations.
| Parameter | Injection | Soluble powder | Oral solution |
|---|---|---|---|
| Vehicle | Water for Injection | Potable water | Purified water |
| pH target | 3.8–5.0 | 3.5–4.5 | 4.0–5.5 |
| Processing temperature | 20–30°C | 25–35°C | 20–25°C |
| Filtration | 0.22 µm PVDF | 100–250 µm mesh | 10 µm cartridge |
| Critical release standard | USP <71>, USP <85> | USP <61>, USP <62> | USP <61>, USP <62> |
Dry oral solid dosage forms for companion animal products are manufactured by low-shear wet granulation or direct compression only after the API has been assayed for oxymatrine-to-matrine ratio, loss on drying, and tapped bulk density. The API from different extraction batches can vary in tapped bulk density from 0.30 g/mL to 0.55 g/mL; blends prepared from low-density lots exhibit poor flow through a rotary press and are prone to capping at compression forces above 15 kN. A typical tablet batch is granulated with 5–10% povidone solution in a high-shear mixer, tray-dried at 50°C until loss on drying is 2.0–3.0%, then milled through a 0.8 mm screen. Magnesium stearate is added at 0.5–1.0% w/w in the final blending step; higher levels reduce tablet hardness below 40 N. The final tablets are compressed to a hardness of 50–80 N and a disintegration time of ≤30 min per USP <701>. Capsule formulations are filled into size 0 or size 1 hard gelatin capsules at a target fill weight of 300–500 mg, using a tamping pin station adjusted to the granule’s Carr index. Uniformity of dosage units is verified by USP <905> with an acceptance value ≤15.0. The process bottleneck is hygroscopicity: the oxymatrine-rich API absorbs moisture above 60% relative humidity, causing punch sticking and capsule shell brittleness. The manufacturing suite is therefore maintained at 35–45% relative humidity and 18–22°C, and bulk containers are sealed with desiccant sachets after sampling. Finished oral solids must comply with the heavy-metal and residual-solvent limits of the destination pharmacopoeia; where no monograph exists, ICH Q3D element risk assessment and VICH GL18 residual solvent testing apply.
Where the target feed mill lacks a dedicated premix line, the API is converted into a low-dust premix powder by spray-adsorption onto maltodextrin or calcium carbonate. The process begins only after the API’s particle-size distribution has been measured by laser diffraction; if the span exceeds 2.0 and the fine fraction below 45 µm is greater than 40%, static charging during transfer creates predictable assay failures in the first and last 10 kg of the batch. The API is therefore pre-dispersed in a 5% aqueous binder solution and sprayed onto the carrier in a fluid-bed granulator with an inlet air temperature of 60–70°C and spray rate of 80–120 g/min per kg of carrier. After the granulate reaches a final moisture of ≤4.0%, it is sieved through a 500 µm screen and blended with antistatic colloidal silica at 0.5–1.5% w/w. The final powder is filled into 20 kg anti-static polyethylene liners and labelled with the total alkaloid concentration, which is usually 10–20 g/kg for in-feed use. Dustiness is measured by a Heubach rotating drum or equivalent gravimetric method; the limit is set at ≤2 mg/m³ for operator exposure. The finished powder is incorporated into feed cubes or top-dressed onto feed at the farm; top-dressing without prior dilution is not recommended because localised high concentrations may cause feed refusal. Where the target species is a ruminant, the formulation must avoid unprotected alkaloid release in the rumen if the authorization specifies a bypass or post-ruminal presentation; this is achieved by coating the granulate with a pH-dependent lipid matrix, but published data for this specific configuration is limited. Release compliance for feed-use powder follows ISO 22000 prerequisite programme documentation, with sampling plans per ISO 2859-1 for visual defects and label verification.
Aquaculture feed integration demands a different granule-binding strategy because final pellets are extruded at temperatures above 80°C and dried at 90–105°C, conditions that can degrade the heat-sensitive alkaloid fraction. To avoid exposing the API to the extrusion barrel, the active component is applied after extrusion by vacuum coating: the pellets enter a vacuum coater and the pressure is reduced to −0.08 MPa to open internal pores, then a fish-oil suspension containing the API at 2–5 g/kg of feed is sprayed at 40–50°C. The coater then vents to atmospheric pressure to pull the oil into the pellet core; this yields a final water-stable pellet with a leaching loss of less than 10% after 2 h immersion. Inclusion in shrimp and fish feed is restricted to jurisdictions where the API is registered as a veterinary feed additive for aquatic species; in many markets its use in aquaculture is not permitted, and formulators must verify the legal status before quoting a formulation. The available industrial data for aquatic species is limited at production scale, so pilot extrusion tests are run with each new pellet recipe to measure the interaction between the API and fishmeal lipids. The main process bottleneck is pellet buoyancy: vacuum coating with high oil loads above 6% can reduce sinking speed, so specific gravity is measured by salt flotation. The final coated pellet is packed in 20 kg woven sacks with an inner PE liner and stored below 30°C; oxidation of the fish-oil carrier is monitored by peroxide value below 5 meq/kg at the time of bagging.
Competitive Kushen Injection Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Kushen Injection Veterinary Grade API is a low-endotoxin quinolizidine-alkaloid active pharmaceutical ingredient derived from dried roots of Sophora flavescens Aiton. The grade is standardised to matrine (C15H24N2O, CAS 519-02-8) and oxymatrine (C15H24N2O2, CAS 16837-52-8) and is supplied as a water-soluble powder or sterile-filtered aqueous concentrate. The same API is specified for incorporation into tablets, injectable solutions, capsules, powders, granules, premixes, and drinking-water solutions, provided the finished batch is revalidated for the intended route. Catalogue model numbers are not uniform across manufacturers; procurement is based on grade designation, certificate of analysis, and route-specific acceptance criteria rather than a common trade model.
The botanical matrix is not a synthetic single-marker API. The specification therefore includes chromatographic identity, total alkaloid assay, related alkaloid profile, residual solvent control, elemental impurity limits, microbial quality, and bacterial endotoxins. For a multi-dosage-form veterinary API, the injection route imposes the most restrictive controls, while tablet, capsule, powder, granule, premix, and solution applications tolerate a broader but still controlled impurity profile.
Raw plant material is authenticated by macroscopic, microscopic, and thin-layer chromatographic methods prior to extraction. The root should be free from visible fungal staining and atypical root fragments. Because alkaloid distribution varies with harvest year, drying method, and extraction solvent, the final API is not released on crude extract ratio alone. Release criteria are expressed as total quinolizidine alkaloid concentration on a dried basis, measured by high-performance liquid chromatography using a C18 column (250 × 4.6 mm, 5 µm) and ultraviolet detection at 205–220 nm. Quantification is performed against reference standards for matrine and oxymatrine, with a simultaneous fingerprint for sophocarpine when required by the manufacturer specification. Where applicable, method conditions follow general chapter 0512 HPLC of the Chinese Veterinary Pharmacopoeia 2020 edition.
Harvest timing of Sophora flavescens root influences the matrine-to-oxymatrine ratio. Published quantitative harvest studies for veterinary suppliers are limited; therefore, a batch-specific chromatographic ratio is more reliable than a fixed extract marker specification. The manufacturer should provide residual solvent data according to VICH GL18 and elemental impurity data according to VICH GL19. Botanical raw material must also be assessed for pesticide residues and aflatoxins where regional monographs require, for example USP <561> or equivalent local chapters.
Compared with feed-grade or oral-grade extracts, injection-grade Kushen API is distinguished less by total alkaloid content than by pyrogen, bioburden, particulate, and residual solvent controls. Feed-grade extracts may contain acceptable levels of bacterial endotoxin, yeast and mould, and nonvolatile plant residues because the exposure route is oral and the finished feed is not sterile. Injection-grade material is supplied with a validated endotoxin limit, a defined total aerobic microbial count, and absence of specified pathogens. A supplier certificate of analysis may specify bacterial endotoxins at ≤0.5 EU/mg, total aerobic microbial count ≤100 CFU/g, and total combined yeast and mould count ≤10 CFU/g; these values are not harmonized across all veterinary pharmacopoeias and should be confirmed against the target species and finished dosage form.
Injection-grade API is not automatically sterile. Sterility is a finished-product attribute. The API must nevertheless possess a sufficiently low bioburden to permit terminal sterilisation or aseptic filtration without exceeding the finished-product endotoxin limit. Residual solvents must also be controlled more tightly when the API is intended for parenteral use. Ethanol used in extraction and recrystallization is normally limited to 0.5% for oral dosage forms if it remains as the principal solvent, while class 2 solvents such as methanol, dichloromethane, and toluene are controlled at VICH GL18 limits. Elemental impurities are risk-assessed per VICH GL19; botanical products can accumulate lead, cadmium, arsenic, and mercury from soil. Typical release limits for the botanical API include lead ≤5 ppm, cadmium ≤1 ppm, arsenic ≤2 ppm, and mercury ≤0.1 ppm; these values are illustrative and must be verified against the supplier certificate of analysis and jurisdiction.
Manufacturing commonly uses aqueous-ethanol extraction followed by macroporous adsorption resin chromatography. The extraction solvent composition influences the matrine-to-oxymatrine ratio and the retention of polysaccharides. Ethanol fractions above 70% v/v tend to narrow the alkaloid profile but may co-elute lipophilic plant pigments. The resin eluate is concentrated under vacuum below 60 °C to reduce thermal degradation of oxymatrine, then filtered through a sterilizing-grade polyethersulfone membrane with a nominal pore size of 0.22 µm when the API is supplied as a liquid concentrate. For powder, the concentrate may be spray-dried with a cyclone and baghouse collection. Powder bulk density is controlled because low bulk density below 0.35 g/mL can create filling consistency problems in hard capsule operations and increase dust loss during tablet compression. Ultrafiltration membranes with molecular weight cut-offs of 10 kDa or lower are sometimes used for depyrogenation; published data for oxymatrine rejection and yield loss in this specific application are limited, so process validation is required for each membrane cassette configuration.
Formulators should not assume that one particle-size distribution and moisture specification is optimal for every dosage form. A direct-compression tablet formulation requires adequate powder flow. If the API has a Carr index above 25%, glidants and dry granulation or slugging are used. Process engineers operating rotary tablet presses observe capping and weight variation when residual moisture exceeds 5%; pre-drying in a vacuum dryer at 40–50 °C is therefore specified before compression. Fluidized-bed granulation at an inlet air temperature of 50–60 °C is common for wet-granulated tablets, but the aqueous binder spray rate must be limited because the alkaloid powder becomes sticky at high humidity.
For premix and powder applications, the API content is generally low. A geometric dilution sequence is used in a ribbon or paddle mixer to reach a coefficient of variation below 5%. Twin-shell blenders with an intensifier bar are used when the premix contains free-flowing carriers such as lactose monohydrate or corncob granules. For drinking-water solutions, the API is added to a small volume of water for reconstitution and then mixed into the medicated water tank under continuous agitation. Solution pH is maintained between 4.0 and 6.5 to retain the alkaloid salt in solution. Alkaline pH above 8.0 may precipitate the free base and reduce delivered dose.
Injectable solutions are prepared by dissolving the API in Water for Injection and adjusting tonicity with sodium chloride. Terminal sterilisation at 121 °C for 15 min is feasible only if the finished container-closure integrity and solution pH stability have been demonstrated. Aseptic filtration through a 0.22 µm sterilizing-grade filter is validated by filter integrity testing according to ASTM F838-20. The injection-grade API is not a single-dose sterile product; it is a low-burden API intended to support such downstream processing.
Residual solvents must be quantified at the API stage, not inferred from the finished product. Because the same API lot may be split across tablet, injection, capsule, powder, granule, premix, and solution batches, the release documentation should carry the most restrictive route-specific data that apply. Ethanol is normally limited to 0.5% for oral dosage forms if it is the principal residual solvent, while class 2 solvents are controlled at VICH GL18 limits. Methanol, dichloromethane, toluene, and n-hexane should be monitored when the extraction and resin-elution steps use solvent mixtures. Residual solvent results are reported in ppm or mg/g, with the method stated on the certificate of analysis.
Elemental impurities for botanical APIs are risk-assessed per VICH GL19. Because Sophora flavescens roots are cultivated and harvested from soil, the lead, cadmium, arsenic, and mercury burden can vary by region and drying process. The API supplier should provide a validated inductively coupled plasma mass spectrometry method with limits that match the target species and finished dosage form. Additional tests for pesticide residues may be required under USP <561> for articles of botanical origin, or equivalent regional monographs. Aflatoxin controls are applied when the root may be susceptible to post-harvest fungal contamination.
The following table lists release criteria frequently referenced for injection-grade Sophora flavescens API. Values are lot-specific and should be confirmed against the supplier certificate of analysis before use in a finished veterinary medicinal product.
| Parameter | Release criterion | Analytical basis |
|---|---|---|
| Appearance | Pale yellow to off-white powder; clear to slightly opalescent after dissolution | Visual inspection |
| Identification | Retention times corresponding to matrine and oxymatrine reference standards | HPLC |
| Total quinolizidine alkaloids, dried basis | ≥95.0 % | HPLC, 205–220 nm |
| Matrine | Report result | HPLC |
| Oxymatrine | Report result | HPLC |
| Loss on drying | ≤5.0 % | Oven or vacuum drying |
| Residue on ignition | ≤0.5 % | Muffle furnace |
| Bacterial endotoxins | ≤0.5 EU/mg | USP <85>, EP 2.6.14 |
| Total aerobic microbial count | ≤100 CFU/g | Compendial microbial enumeration |
| Total combined yeast and mould count | ≤10 CFU/g | Compendial microbial enumeration |
| Lead | ≤5 ppm | ICP-MS, VICH GL19 |
| Cadmium | ≤1 ppm | ICP-MS, VICH GL19 |
| Arsenic | ≤2 ppm | ICP-MS, VICH GL19 |
| Mercury | ≤0.1 ppm | ICP-MS, VICH GL19 |
| Residual solvents | Class 2 and class 3 solvents within limits | VICH GL18 |
| Sterility | Not claimed for API; finished product requirement | Finished dosage form |
Because published harmonized limits for this specific botanical injection-grade API are limited, the finished-product manufacturer must set internal limits based on risk assessment, target species, and route of administration. The values above are not a replacement for a supplier certificate of analysis.
Release documentation changes by administration route. Injectable applications require bacterial endotoxin data, bioburden data, and filter compatibility information. Oral solid dosage forms require particle-size distribution, powder flow, and moisture data. Premixes require verification of blend uniformity and carrier compatibility. Drinking-water solutions require dissolution time in defined water hardness and pH stability data. The table below summarises the route-specific emphasis.
| Route / dosage form | Critical API attributes | Reference standard or test |
|---|---|---|
| Injectable solution | Endotoxin, bioburden, residual solvents, filterability, pH stability | USP <85>, VICH GL18, filter integrity ASTM F838-20 |
| Tablet / capsule | Particle-size distribution, bulk density, moisture, flow | Compendial sieving, tapped density |
| Powder / granule | Bulk density, loss on drying, blend uniformity | Compendial moisture, HPLC assay |
| Premix | Low inclusion rate, carrier compatibility, coefficient of variation | HPLC assay, mixing validation |
| Drinking-water solution | Dissolution time, pH stability, hardness tolerance | Dissolution test, pH measurement |
Operational boundaries include pre-drying at humidity above 60% relative humidity to prevent agglomeration, avoidance of strong oxidisers, and avoidance of alkaline buffers above pH 8.0 because free-base precipitation may occur. Combination with concentrated metal-salt solutions is not recommended without compatibility testing; published data for admixture compatibility with veterinary injectable excipients are limited.
