| HS Code | 354474 |
| Product Name | Fuzheng Jiedu Granules Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Product Type | Veterinary Grade Active Pharmaceutical Ingredient (API) derived from Fuzheng Jiedu Granules |
| Dosage Forms Supported | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Primary Active Components | Astragalus membranaceus extract, Glycyrrhiza uralensis extract, and other standardized traditional Chinese medicinal herbal constituents |
| Physical Form | Granular or powdered substance with a characteristic herbal odor and slightly sweet-bitter taste |
| Solubility | Partially soluble in water with fine suspension formation suitable for veterinary formulations |
| Pharmacological Action | Enhances immunity, supports vital qi, clears heat, removes toxins, improves resistance against pathogenic challenges, and aids in stress recovery |
| Therapeutic Indications | Auxiliary prevention and treatment of viral infections, immunocompromised states, toxemia, and metabolic stress in livestock and poultry |
| Target Species | Pigs, chickens, cattle, sheep, and other food-producing veterinary species |
| Usage And Formulation Application | Can be used as an API base for the preparatory manufacture of tablets, injections, capsules, powders, granules, premixes, and oral solutions with appropriate veterinary excipients |
| Storage Conditions | Keep sealed in a dry, cool, well-ventilated place, protected from moisture, heat, and direct light |
| Shelf Life | 24 months under recommended storage conditions |
| Quality Compliance Profile | Meets veterinary-grade acceptance criteria for active component content, heavy metal limits, microbial purity, residual solvents, and particle uniformity |
As an accredited Fuzheng Jiedu Granules 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 | Fuzheng Jiedu Granules Veterinary Grade API: 25 kg drums, double-lined with polyethylene bags, sealed for safety and stability. |
| Container Loading (20′ FCL) | 20' FCL loading: Fuzheng Jiedu veterinary API, drum-packed, palletized, secured for safe transport of finished granules/powders. |
| Shipping | Shipping: Available worldwide via air, sea, or courier with tamper-evident, moisture-resistant packaging. Temperature-controlled options available to preserve stability. Compliance with veterinary API regulations, including proper documentation and customs clearance, is ensured. Hazard and handling labels applied for safe transit. |
| Storage | Store Fuzheng Jiedu Granules Veterinary Grade API in tightly sealed, moisture-proof containers in a cool, dry, well-ventilated area. Protect from direct sunlight and high temperatures. Keep away from incompatible substances and food. Ensure container is properly labeled. Ideal storage temperature: below 25°C, with low humidity. |
| Shelf Life | Shelf life is 24 months from manufacture when stored unopened in a cool, dry, well-ventilated area. |
In rotary tablet press campaigns using the Fuzheng Jiedu Granules Veterinary Grade API, the hygroscopic granulate is pre-sieved through a 20 mesh (0.850 mm) oscillating screen with dry air at 35–40 °C until free surface moisture falls below 5.0% as measured by halogen loss-on-drying. A direct compression matrix is assembled at 45–60% w/w API granulate, 20–35% w/w microcrystalline cellulose PH-102, 2–4% w/w crospovidone type A, and 0.5–1.0% w/w magnesium stearate. The blend is mixed in a V-blender at 55–65% fill volume and 12–15 rpm for 10–14 min; mixing beyond 15 min segregates extract fines from the cellulose carrier on production-scale equipment. Tablets are compressed at 8–15 kN main compression and 2–4 kN pre-compression to a hardness of 60–90 N. Friability is controlled to ≤1.0% by Ph. Eur. 2.9.7, and disintegration is measured by Ph. Eur. 2.9.1 in water at 37±2 °C. When batch-to-batch moisture exceeds 5.5%, capping and edge chipping increase on presses running above 45 rpm; therefore, pre-compression force is increased and friability is tested every 30 min during the compression run. Terminal product is a scored veterinary tablet for oral administration. Swab sampling of punch faces and die bores is specified because extract residues form a tacky film under compression heat.
The granulate is dissolved in Water for Injections at 25–40 °C under closed-vessel agitation with an overhead stirrer at 200–400 rpm. The resulting solution is adjusted to pH 5.5–7.0 with 0.1 M citrate or phosphate buffer. Tonicity is adjusted with sodium chloride to 280–320 mOsm/kg measured by freezing point depression. Clarification uses a 0.45 µm polyethersulfone prefilter, followed by a 0.22 µm sterilizing-grade membrane. Filtration pressure is maintained below 0.3 MPa to avoid streaming of colloidal extract fractions. The filtrate is filled under ISO 14644-1 Class A laminar air with a Class B background according to EU GMP Annex 1. Terminal sterilization by autoclaving at 121 °C is avoided because published data for this specific multi-herb extract formulation is limited and heat-induced flocculation cannot be excluded without product-specific kinetic stability studies. Particle burden is monitored by light obscuration per Ph. Eur. 2.9.19 with acceptance limits ≥10 µm not more than 6,000 per container and ≥25 µm not more than 600 per container. Compatibility with butyl rubber stoppers and borosilicate glass vials is tested under 40±2 °C and 75±5% relative humidity for 14 days. Divalent cations in cleaning residuals or WFI distribution piping may generate visible haze due to phenolic and polysaccharide components; stainless steel of grade 316L and passivated surfaces are specified.
Before engaging dosator-type capsule fillers, the cohesive fraction of the API granulate is evaluated with a powder rheometer and tapped density analyzer. A capsule blend is prepared from 50–70% w/w API granulate, 20–35% w/w lactose monohydrate 200 mesh, 0.5–1.5% w/w colloidal silicon dioxide, and 1–2% w/w sodium stearyl fumarate. Target loss-on-drying is ≤3.0% before encapsulation; above 3.5%, the powder adheres to dosator pins and causes fill weight drift. Hausner ratio is maintained at ≤1.25 and Carr compressibility index at ≤20% to ensure reproducible filling on intermittent-motion capsule machines running at 30,000–60,000 capsules/hour. Size 0 or 1 hard gelatin or HPMC capsules are filled to 300–500 mg target weight with ±3% individual fill tolerance. The line is equipped with 100% checkweighing and metal detection at 0.8 mm ferrous, 1.2 mm non-ferrous, and 1.5 mm stainless steel detection limits. Release identification is performed by thin-layer chromatography against botanical reference extracts, not by a single-marker HPLC assay, because the extract granulate is a multi-component herbal preparation. Terminal product is a veterinary hard capsule for oral administration. Batch changeover requires vacuum extraction and disassembly of the powder bowl and dosator head; residual extract dust on polymer contact parts is hygroscopic and can cement within 8 h at 60% RH.
| Solid-dose operation | Pre-blend LOD limit | Uniformity criterion | Critical machine parameter |
|---|---|---|---|
| Direct compression veterinary tablet | ≤5.0% | ≤2.0% RSD by Ph. Eur. 2.9.40 | 8–15 kN compression force |
| Dosator capsule filling | ≤3.0% | ≤2.0% RSD by Ph. Eur. 2.9.40 | ≤1.25 Hausner ratio |
| Auger sachet powder/granule | ≤2.5% | ≤5.0% RSD by Ph. Eur. 2.9.40 | ≤2.0% fill weight CV |
For unit-dose oral powder sachets, the API granulate is dry-blended with anhydrous dextrose or lactose monohydrate at a ratio of 10–20% w/w API, 0.5–1.0% citric acid, 0.2–0.5% colloidal silicon dioxide, and sufficient vehicle to target 2.0–5.0 g fill weight. The powder blend is dried to a loss-on-drying of ≤2.5% before stick-pack forming. For granule-filled sachets, the blend is compacted on a roller compactor at 4–6 kN/cm roll force and dry-screened through 1.0 mm and 1.6 mm mesh to give free-flowing granules with bulk density 0.55–0.75 g/mL. On vertical form-fill-seal machines with auger dosing, fill weight coefficient of variation is maintained at ≤2.0% at 40–60 packs/min. Seal integrity is tested at −0.08 MPa vacuum decay and peel strength above 3.0 N/15 mm on laminate foil. Because the extract granulate is hygroscopic, the primary packaging includes aluminum foil laminate with a moisture vapor transmission rate below 0.5 g/m²/24 h at 38 °C/90% RH. Terminal product is a water-dispersible oral powder or granule for administration after dissolving in drinking water or drench. Mixing validation requires sampling 10 locations per blend batch and demonstrating total extractives RSD ≤5.0% according to Ph. Eur. 2.9.40. Electrostatic charging of extract fines during auger filling at 20–30% relative humidity causes powder adhesion to the forming collar; therefore, area humidity is controlled at 45–55% RH with grounded stainless steel contact surfaces.
The veterinary grade granulate is first triturated with a compatible carrier such as calcium carbonate, wheat middlings, or rice hull powder at 1:9, then further diluted to a final premix potency of 1:100 or 1:1000 w/w before delivery to feed mills. Mixing is performed in a horizontal ribbon mixer at 60–70% fill volume for 8–12 min, with inter-batch cleaning of dead zones at shaft ends and discharge gates. Homogeneity of the premix is verified by sampling 20 points according to ISO 6497:2005; the acceptance criterion is a coefficient of variation below 5.0% for total extractive marker. The final medicated feed is mixed in a double-ribbon or paddle mixer to a target inclusion of 1–5 kg premix per tonne of complete feed. Carryover is controlled through sequential flushing with a non-medicated feed batch; validated residues in the following batch must not exceed 1.0% of the active substance content of the previous medicated batch, consistent with the cross-contamination limits of Regulation (EU) 2019/4 on medicated feed. Terminal product is a complete feed or top-dress powder. Direct addition of the undiluted granulate to feed is not specified because fine extract particles segregate in vertical screw conveyors and adhere to polyethylene bucket elevator surfaces under static charge. Published data for this specific herbal API in medicated feed matrices is limited; therefore, site-specific recovery validation with a total extractives marker is required before commercial distribution.
Because the granulate is intended for drinking water application, reconstitution in hard water is evaluated before field use. A stock solution is prepared at 10–20% w/v in potable water at 25–30 °C under agitation for 15–20 min. The stock solution is then diluted through a proportional dosing pump at 1:500 to 1:1000 into the drinking line. A 75 µm inline strainer is installed before the dosing pump to prevent nozzle blockage from undissolved extract particles. Hard water containing calcium and magnesium above 250 mg/L as CaCO₃ may produce turbidity; chelation with 0.1–0.3% sodium citrate or ethylenediaminetetraacetic acid disodium salt is used when water hardness exceeds the limit. The solution pH is maintained between 4.5 and 6.5 to suppress flocculation and microbial growth. Chlorinated water at free chlorine levels above 1.0 mg/L oxidizes phenolic constituents and is neutralized with sodium thiosulfate at stoichiometric equivalence prior to reconstitution. Dosing pump contact materials are specified as 316L stainless steel, EPDM, or PTFE; natural rubber components are excluded due to extract-mediated swelling. The diluted solution is used within 12 h at ambient temperature and within 24 h under 2–8 °C protection. Terminal product is a medicated drinking water for poultry or swine lines. Published stability data for this specific extract solution under field water matrices is limited; a pilot-scale compatibility trial with the target farm water source is required.
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Fuzheng Jiedu Granules Veterinary Grade API is a dry botanical extract granulation supplied for further manufacture into tablets, injections, capsules, powders, final granules, premixes, and solutions. The model structure uses the symbol FZJ-VET-G followed by a particle-size suffix. The standard grade FZJ-VET-G/80 is specified for oral solid dosage forms and dry premixes; FZJ-VET-G/120 is the fine-particle designation for solution and injectable preconcentrate development; FZJ-VET-G/60 is intended for high-loading premix carriers. The material is not a finished veterinary medicine and is not supplied sterile, depyrogenated, or ready for injection. It is released under a veterinary GMP quality system and is intended to be further processed by manufacturers holding appropriate veterinary drug manufacturing authorisations. The granulated presentation is designed to reduce dust generation, improve flow, and lower segregation tendency compared with raw botanical powders while retaining dispersibility in water for downstream solution preparation. The product is a multicomponent extract; potency and quality are controlled by marker-based HPLC release rather than by a single isolated active pharmaceutical ingredient. It is not labelled with a standalone therapeutic claim; final efficacy, target species, and withdrawal period are determined by the finished product marketing authorisation.
The primary distinction is process control of particle size, moisture, microbial load, and marker content. Crude botanical powder contains whole plant cell matrix, seasonal marker variation, fibre, and soil-borne microbial contamination. The granulated API is extracted and densified, then sieved to a defined particle-size band. Unlike a pure synthetic API, it is not standardised to a single molecule; its activity remains a function of the total extractable profile. However, the granulated form reduces uncontrolled variables during weighing and blending. In production-scale ribbon blenders, fine powders can fluidise and segregate, while the densified granules settle closer to common excipient densities. The bulk density of the standard grade is typically 0.48–0.60 g/cm³, which is closer to lactose monohydrate and microcrystalline cellulose than the 0.25–0.35 g/cm³ range often observed for fine botanical powders. Dust exposure during charging is lower, but local exhaust ventilation and containment are still required because the extract can form a respirable dust if broken. The product does not eliminate the need for marker-specific testing; it changes the sourcing risk profile from uncontrolled botanical powder to a controlled extract granulation.
Tablet and capsule processing requires loss on drying below 5.0% and not more than 5% retained on an 80-mesh screen. Direct compression may be used when the extract content is low, but at higher extract loads the granulation can reduce compactibility. High-shear wet granulation is commonly performed in a vertical granulator with an impeller speed of 200 rpm and a chopper speed of 1500 rpm; the endpoint is often judged by torque or power draw rather than fixed time because polysaccharide-rich botanical extracts release water progressively during massing. A binder solution containing polyvinylpyrrolidone at 2–5% w/w may be added, and drying is controlled to a final loss on drying of 2.0–4.0%. Overdrying can increase tablet hardening and disintegration time. Capsule filling is performed on dosator or tamping-pin machines after the granulate is blended with 0.5–1.0% colloidal silicon dioxide or equivalent glidant. In-feed powder and final granule formulations require geometric dilution into a suitable carrier, with a blend uniformity target of relative standard deviation not exceeding 5.0% after the defined mixing time. The granulated API improves flow and uniformity, but it does not remove the need for blender qualification or periodic sampling.
Injectable and ophthalmic solution manufacture is the most restrictive route. FZJ-VET-G/120 may be selected for solution development, but it is not supplied sterile or pyrogen-free. The extract must be dissolved in Water for Injection under controlled shear, adjusted to pH 5.0–7.0, clarified through a 0.45 µm filter, and then sterilised through a 0.22 µm filter. Botanical extracts contain intrinsic endotoxin from the source plant material; sterilising filtration alone is not a recognised depyrogenation step. A validated depth filtration, charged membrane, or ultrafiltration step is required before final sterilisation unless the process validation demonstrates adequate endotoxin reduction. Polysaccharides in the extract may increase solution viscosity and reduce filter throughput; membrane sizing should be determined by pilot filtration studies using the actual solution composition. The solution may darken if held at alkaline pH above 8.0, and strong oxidising agents are incompatible because they degrade marker compounds. Terminal autoclaving of the dry granulate is not recommended because it can cause agglomeration and reduce marker recovery. Published data for this specific injectable configuration is limited; each manufacturer must generate route-specific endotoxin, particulate, and stability data before registration.
Premix and liquid feed applications use the same API but are controlled by adsorption, water uptake, and particle adhesion. For dry premixes, the 80-mesh granule is mixed into a mineral or lactose carrier at 1%–5% active inclusion; the final mixture should demonstrate a relative standard deviation below 5.0% and pass sieve segregation testing after pack-off. High ambient relative humidity above 60% causes caking because the extract contains hygroscopic sugars and polysaccharides. Opened containers should be reclosed immediately, and storage areas should be maintained below 25°C with desiccant where necessary. For oral solution preparation, the granulate is dispersed in water at 25–40°C with high-shear mixing, then passed through a 100 µm strainer before final dilution. The product may be unstable in strongly acidic media below pH 3.0 or strongly alkaline media above pH 9.0; precipitation can occur. If a multidose oral solution is formulated, preservative compatibility with parabens or benzalkonium chloride should be verified because botanical polyphenols may bind preservatives and reduce assay recovery.
Release is based on a certificate of analysis with compendial or validated in-house methods. The product is a multicomponent extract; therefore the specification includes marker assays rather than a single potency value. Table 1 presents the standard release categories for the oral-grade granulate. Injectable development requires additional limits for bacterial endotoxin, insoluble particulate matter, and final sterility that are not part of the standard oral-grade specification.
| Parameter | Acceptance criterion | Test basis |
|---|---|---|
| Appearance | Light brown to brown free-flowing granules | Visual inspection |
| Particle size | NLT 95% through 80 mesh (180 µm) | USP<786> / Ph. Eur. 2.9.12 |
| Loss on drying | ≤ 5.0% | USP<731>, 105°C |
| Total ash | ≤ 6.0% | USP<730> |
| Heavy metals | Pb ≤ 10 ppm; Cd ≤ 1 ppm; As ≤ 2 ppm; Hg ≤ 0.5 ppm | ICP-MS after closed-vessel digestion |
| Total aerobic microbial count | ≤ 103 CFU/g | USP<61> |
| Yeast and mould | ≤ 102 CFU/g | USP<61> |
| Escherichia coli | Absent in 1 g | USP<62> / ISO 16649-2:2001 |
| Salmonella | Absent in 25 g | ISO 6579-1:2017 |
| Residual solvents | Class 2 solvents ≤ compendial limits; ethanol ≤ 5000 ppm if declared in process | USP<467> / ICH Q3C |
Because the same granule is compacted, filtered, and dry-mixed, the relevant specification parameters must be selected according to the intended dosage form. For tablet and capsule manufacture, loss on drying, particle-size distribution, compactibility, and disintegration are process-critical. For solutions and injectables, dissolution rate, bioburden, endotoxin, filter adsorption, and insoluble particulate matter dominate. The 80-mesh grade may be acceptable for oral solids and premixes, but the 120-mesh grade is preferred for solution manufacture because reduced particle size increases wetting and dissolution. For tablets requiring rapid disintegration, a superdisintegrant such as croscarmellose sodium at 2–5% w/w may be required; high extract loading can extend disintegration beyond 15 min if the granule is compressed too densely. In sustained-release capsules, the extract can alter hydration rate and slow release. A single API specification therefore does not guarantee suitability for all routes. The manufacturer must perform dosage-form-specific development studies and cannot rely solely on the supplier’s release specification.
Compared with non-veterinary botanical extracts, this API is controlled for veterinary manufacturing use, including carryover risk, animal-species safety, and cleaning validation documentation. It should not be used as a substitute for a registered veterinary medicine, and in food-producing species the final product must carry the appropriate withdrawal period where required. Compared with a synthetic single-molecule antiviral or immune-modulating API, the granulated extract has no single pharmacokinetic peak. Bioequivalence cannot be demonstrated by a single plasma concentration curve; equivalence is based on marker content, marker ratio, dissolution profile, and batch-to-batch consistency in the final veterinary dosage form. Compared with single-herb extracts, the drying behaviour of this multi-plant extract is influenced by co-extracted polysaccharides. The glass transition temperature may be low, and spray drying can become sticky if the outlet temperature exceeds 80°C. Manufacturers replacing a single-herb extract with this multi-plant granulate should re-qualify granulation endpoints, drying profiles, and cleaning procedures because the broader chemical fingerprint may affect residue detection.
Table 2 summarises the comparative dimensions that affect sourcing and formulation decisions.
| Comparison dimension | FZJ-VET-G/80 | Crude botanical powder | Human botanical extract | Synthetic single-molecule API |
|---|---|---|---|---|
| Standardisation basis | Multi-marker HPLC release | Visual or thin-layer identification; seasonal variation | Often single-marker or food-grade | Single active assay |
| Microbial load | ≤ 103 CFU/g oral grade | Variable; may exceed 105 CFU/g | May be controlled for human oral intake | Low bioburden or sterile |
| Residual solvent control | Controlled to ICH Q3C classes | Not routinely tested | May follow food or dietary supplement limits | Controlled for synthesis solvents |
| Dosage-form fit | Multi-formulation granule | Poor flow, high dust, segregation | Usually fine powder; may require granulation | Crystalline; may require milling |
| Regulatory status | Veterinary API requiring downstream GMP | Raw botanical or feed herb | Not automatically suitable for veterinary use | Requires veterinary drug approval |
Operational boundaries and incompatibilities are governed by the extract’s hygroscopicity and polyphenol content. The dry granulate should be pre-dried before tableting when ambient relative humidity exceeds 60%. Prolonged storage above 25°C is not recommended; accelerated storage at 40°C and 75% relative humidity may show darkening and marker loss. Strong oxidising agents should not be mixed with the granulate because marker degradation can occur. Strong alkaline granulation aids that raise the wet mass pH above 9.0 should be avoided because oxidative browning may occur. The dry granulate should not be autoclaved unless the process is validated; dry heat or steam sterilisation can cause agglomeration and reduce marker recovery. In liquid formulations, high concentrations of strong anionic surfactants should not be used without compatibility testing because precipitation can occur. The product is intended solely for incorporation into veterinary medicines by authorised manufacturers; it is not a finished dosage form, not a direct farm feed ingredient, and not a substitute for a registered veterinary medicinal product.
