| HS Code | 669034 |
| Product Name | Ardisiae Japonicae Herba Veterinary Grade API |
| Botanical Source | Ardisia japonica (Thunb.) Blume |
| Pharmaceutical Part | Whole herb |
| Active Marker Compounds | Bergenin, ardisin, saponins, flavonoids, coumarins |
| Api Grade | Veterinary grade bulk active pharmaceutical ingredient |
| Indications | Antitussive, expectorant, anti-asthmatic, anti-inflammatory, antibacterial; supports respiratory health in veterinary use |
| Target Animal Species | Swine, cattle, sheep, goats, poultry, rabbits |
| Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Quality Specifications | Complies with veterinary pharmacopoeia standards; standardized for herbal API assay and impurity limits |
| Storage And Shelf Life | Store in tightly sealed containers in a cool, dry, dark place; avoid moisture; shelf life 24 months when stored as recommended |
As an accredited Ardisiae Japonicae Herba 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 | Packaged in sealed, light-resistant, tamper-evident drums and bags. Supplied as veterinary-grade API powder in 25 kg quantities. |
| Container Loading (20′ FCL) | One 20′ FCL of Ardisiae Japonicae Herba Veterinary Grade API, packed in sealed drums/pallets, secured for safe transport. |
| Shipping | Ship as veterinary-grade herbal API in sealed, moisture-resistant containers. Label clearly with batch number and storage conditions. Keep cool, dry, and away from direct sunlight during transit. Include Certificate of Analysis, Safety Data Sheet, and origin documentation. Ensure compliance with regional veterinary drug transport regulations. |
| Storage | Store in tightly sealed, original containers in a cool, dry, well-ventilated area below 25°C. Protect from light, moisture, and strong odors. Avoid direct sunlight and freezing. Keep away from incompatible substances and foodstuffs. Ensure containers are clearly labeled. Use first-in, first-out rotation. |
| Shelf Life | Shelf Life: 24 months when stored sealed, cool, and dry. Protect from moisture and light. Use before expiry date. |
In nursery pig production where porcine respiratory disease complex is managed by prescription, Ardisiae Japonicae Herba Veterinary Grade API is incorporated into water-soluble granule intermediates at 15.0–30.0 g/kg of granulate, equivalent to 1.5–3.0% w/w of the dry granule mass, with dose rates recalculated on a bergenin marker basis under the applicable 2020 Chinese Veterinary Pharmacopoeia monograph for Ardisiae Japonicae Herba. The production line uses a high-shear mixer with a 10.0–15.0% w/w ethanol-water binder sprayed at 40–50°C, followed by fluid-bed drying at 50–60°C inlet air until loss on drying is below 5.0% by USP <921>; the dried material is screened through 20–60 mesh to maintain dissolution time below 120 s in water at 25°C and pH 6.5–7.5. Sodium citrate at 0.5% w/w and potassium sorbate at 0.1% w/w are incorporated as buffering and preservation agents before the granulate is reconstituted into stock solutions at 1:500–1:1000 dilution. Finished powder and reconstituted oral solution are released under residual solvent limits from VICH GL18, stability protocols from VICH GL5 for climatic zones III and IV, and EU GMP Part II requirements for botanical API handling. Terminal product types include 100 g, 500 g, and 1 kg HDPE jars of water-soluble powder and oral solution concentrate for drinking water administration.
Addition of Ardisiae Japonicae Herba API to pelleted broiler finisher feeds is constrained by the thermal degradation of bergenin during post-pelletization conditioning; pilot-scale pelleting with steam at 65–70°C and die retention below 30 s shows acceptable marker recovery, whereas sustained exposure above 75°C accelerates degradation. Published data for this specific configuration are limited; the stated upper boundary is derived from pilot-batch assays rather than compendial compendia. The premix formulation contains 10.0% w/w of Ardisiae Japonicae Herba extract, 2.0% w/w sodium aluminosilicate as moisture scavenger, 1.5% w/w soybean oil as dust suppressant, and the balance ground limestone carrier. Mixing is performed in a ribbon blender for 15 min with coefficient of variation below 5.0% before the premix is added to feed at 1.0–2.0 kg per metric ton. Where the premix is used as a medicated feed premix, compliance follows EU Regulation 2019/6 for veterinary medicinal products where applicable, with feed hygiene under Regulation (EC) 183/2005 Annex II, and residual solvent control under VICH GL18. Terminal product types are 0.2%–0.5% medicated premixes and top-dress powders for broiler growers, packed in 25 kg multi-wall paper sacks with polyethylene liners.
Compression of bergenin-rich Ardisiae Japonicae Herba extract into canine tablets requires control of aggregate particle size distribution; extract particles above 250 µm cause content uniformity failures under USP <905> with acceptance values exceeding 15.0 in pilot batches, while friability increases above 1.0% when granule moisture falls below 2.5%. An extract standardized to 10.0% bergenin is added at 200 mg per 800 mg tablet core to deliver 20 mg bergenin, representing 25.0% w/w of core mass; the remaining core consists of microcrystalline cellulose 45.0% w/w, lactose monohydrate 24.0% w/w, crospovidone 3.0% w/w, povidone K30 2.0% w/w, and magnesium stearate 1.0% w/w. Wet granulation uses a 5.0% povidone K30 aqueous solution, tray drying at 45°C ± 2°C to 2.5–4.0% moisture, and compression on a 10-station B-tooling rotary press at 8–15 kN; target hardness is 60–90 N, with friability not more than 1.0% and disintegration per USP <701> below 15 min at 37°C. Release testing includes USP <905>, USP <701>, USP <921>, and VICH GL5 stability protocols for climate zones III and IV. Terminal product types are scored tablets in 30-count and 100-count HDPE bottles for prescribed canine respiratory phytotherapy.
Injectable presentations intended as adjunctive therapy in bovine respiratory disease require purified Ardisiae Japonicae Herba fractions because crude powder contains polysaccharides and chlorophyll-derived components that form haze and risk clogging 0.22 µm filters. The formulation uses bergenin at 1.0–2.0 mg/mL in phosphate buffer at pH 5.5–6.5, equivalent to 0.1–0.2% w/v of a purified extract containing not less than 85.0% bergenin; sodium metabisulfite 0.05% w/v is included as antioxidant. Aseptic filling is performed in an ISO 14644-1 Class 5 cleanroom, with 0.22 µm PVDF filtration and filling into 25 mL and 50 mL Type I glass vials with bromobutyl rubber stoppers. Because published data for terminal autoclaving of bergenin-containing solutions are limited, current pilot-batch design relies on aseptic filtration rather than terminal steam sterilization. Sterility conforming to USP <71>, bacterial endotoxin limits under USP <85>, and EU GMP Annex 1 for sterile veterinary products apply; particulate matter is monitored under USP <788>. Terminal product types are 25 mL and 50 mL vials for intramuscular or subcutaneous use where authorized.
For lamb oral drench powders, moisture-activated granulation of Ardisiae Japonicae Herba API uses 0.5–1.5% w/w hydroxypropyl methylcellulose E5 as binder in a top-spray fluid bed, with water addition at 8.0–12.0% of dry powder mass; the extract fraction is 20.0% w/w of the final powder, with sodium citrate 2.0% w/w to buffer the reconstituted drench to pH 6.0–7.0 and anhydrous dextrose q.s. The powders are premixed for 10 min, granulated at inlet air 35–45°C, dried to loss on drying not more than 4.0% by USP <921>, screened through 500 µm, and filled into 50 g high-density polyethylene sachets; each 10 mL drench dose is reconstituted in water at 25°C with a target dispersion time below 60 s. Release and stability requirements include VICH GL5 bracketing or matrixing protocols, USP <921>, the applicable 2020 Chinese Veterinary Pharmacopoeia monograph for identity, and residual solvent control under VICH GL18. Terminal product types are single-dose sachets and 50 g multi-dose oral drench powders for lambs.
Equine respiratory phytotherapy capsules require tamping-pin fill weight control within ±3.0% of target because Ardisiae Japonicae Herba extract bulk density varies from 0.35 g/cm³ to 0.55 g/cm³ depending on residual moisture and particle size; a size 1 hydroxypropyl methylcellulose capsule is filled with 250 mg of extract standardized to 10.0% bergenin plus 0.5% w/w silicon dioxide as glidant, delivering 25 mg bergenin per shell. Fill parameters on a dosing-disc capsule filler use pin height adjusted to achieve 250 mg ± 7.5 mg fill weight; in-process moisture is held at 3.0–5.0% because lower moisture increases electrostatic adhesion to capsule walls and higher moisture softens the hydroxypropyl methylcellulose shell. Release testing includes USP <701> disintegration below 30 min in water at 37°C, USP <711> dissolution with acceptance criteria justified by batch data, USP <921>, and residual solvent control under VICH GL18. Terminal product types are 60-count and 100-count hydroxypropyl methylcellulose capsule containers for prescribed equine respiratory preparations.
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Ardisiae Japonicae Herba Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied under the model family AJH-VET, with two controlled upstream forms: AJH-VET/EP, a native comminuted herb standardized to not less than 0.50% bergenin on a dried basis, and AJH-VET/EX, an aqueous ethanol extract standardized to 4.0–5.5% bergenin. The botanical source is the dried aerial part of Ardisia japonica (Thunb.) Blume; the primary analytical marker is bergenin (328.27 g/mol), with co-extracted flavonoids and triterpenoids retained in the extract grade to preserve the multi-component profile required by the veterinary herbal monograph. Both grades are controlled against Chinese Pharmacopoeia 2020 monograph requirements for identity, residual solvent, heavy metals, microbial limits, and marker content, with additional endotoxin controls applied to the sub-lot intended for injectable manufacturing. The product is an active pharmaceutical ingredient for further processing and is not a finished dosage form.
The native grade is micronized to a particle size D90 not exceeding 75 µm; the extract grade is spray-dried to D90 not exceeding 45 µm and vacuum-dried to moisture not exceeding 6.0%. The distinction between grades determines which dosage-form route is technically feasible. The native grade is appropriate for dry powders, premixes, and hard capsules; the refined extract grade is required where tablet hardness, injection clarity, or solution turbidity are critical. In a production-scale rotary tablet press, native-grade material with residual moisture above 8.0% has shown die-filling variability and capping at compression speeds above 60 rpm. The extract grade at 4.0–5.5% bergenin and moisture ≤ 6.0% can be processed by dry granulation with microcrystalline cellulose and crospovidone at 12–22 kN compression force, giving tablet hardness between 70 N and 110 N and friability below 1.0% when tested according to Chinese Pharmacopoeia 2020 general chapter 0923.
For veterinary herbal APIs, the applicable quality framework combines the monograph of the source herb with veterinary-specific stability and residue guidance. The acceptance limits in Table 1 are used for batch release; they derive from the Chinese Pharmacopoeia 2020 monograph for Ardisiae Japonicae Herba and from VICH GL18 residual solvent guidance for herbal materials processed into multi-dose delivery forms. The AJH-VET/EX injection sub-lot applies an endotoxin criterion of ≤ 0.5 EU/mg because multi-dose injectable solutions for food-producing animals require a total endotoxin load below the relevant parenteral threshold after dilution to the intended dose. Identity is confirmed by thin-layer chromatography against a bergenin reference standard and by high-performance liquid chromatography retention time match within ± 0.2 min.
| Parameter | AJH-VET/EP native grade | AJH-VET/EX refined extract grade | Test reference |
|---|---|---|---|
| Bergenin content | ≥ 0.50% w/w dried basis | 4.0–5.5% w/w dried basis | HPLC, Chinese Pharmacopoeia 2020 general chapter 0512 |
| Loss on drying | ≤ 12.0% | ≤ 6.0% | Chinese Pharmacopoeia 2020 general chapter 0831 |
| Total ash | ≤ 10.0% | ≤ 5.0% | Chinese Pharmacopoeia 2020 general chapter 2302 |
| Heavy metals | Pb ≤ 5 mg/kg, As ≤ 2 mg/kg, Cd ≤ 1 mg/kg | Pb ≤ 5 mg/kg, As ≤ 2 mg/kg, Cd ≤ 1 mg/kg | Inductively coupled plasma mass spectrometry |
| Total aerobic count | ≤ 10^4 CFU/g | ≤ 10^3 CFU/g | Chinese Pharmacopoeia 2020 general chapter 1105 |
| Molds and yeasts | ≤ 10^2 CFU/g | ≤ 10^2 CFU/g | Chinese Pharmacopoeia 2020 general chapter 1105 |
| Escherichia coli | Absent in 1 g | Absent in 1 g | Chinese Pharmacopoeia 2020 general chapter 1105 |
| Salmonella | Absent in 25 g | Absent in 25 g | Chinese Pharmacopoeia 2020 general chapter 1105 |
| Particle size D90 | ≤ 75 µm | ≤ 45 µm | Laser diffraction, ISO 13320:2020 |
| Endotoxin | Not specified for oral grades | ≤ 0.5 EU/mg for injection sub-lot | Chinese Pharmacopoeia 2020 general chapter 1143 |
Batch release statistical control operates with a coefficient of variation for bergenin content not exceeding 3.0% across 10 consecutive lots. This limit is monitored by HPLC using a 250 mm × 4.6 mm C18 column with 5 µm particle size, UV detection at 275 nm, and an acetonitrile–0.1% phosphoric acid mobile phase. The native grade is released against the raw herb monograph; the extract grade is controlled with narrower moisture and ash limits because downstream unit operations such as lyophilization, sterile filtration, and roller compaction respond more sharply to residual non-marker solids.
Direct compression and capsule filling are governed by the flow function coefficient of the chosen grade. The extract grade is specified at not less than 4.0 after slugging on a 20 kN single-punch press and screening through a 1.0 mm sieve. For hard capsules, fill weight is adjusted to deliver the intended bergenin dose per unit; powder rheology testing with a Schulze ring shear tester is used when relative humidity exceeds 60%. Because the extract grade contains hygroscopic fractions, exposed powder beds must not remain open beyond 4 h at 25°C and 65% RH; otherwise lump formation increases sieve retention above 5.0%. Pre-drying to moisture ≤ 6.0% is therefore required before dry granulation at relative humidity above 60%.
In wet granulation for granules and premix intermediates, the binder system is selected to avoid introducing unacceptably high polysaccharide loadings that could reduce bergenin dissolution. A 2.0% w/v povidone K30 solution is used at 8–12% binder volume by mass. Granulation on a twin-screw extruder with an L/D ratio of 20:1 and barrel temperature 30–40°C produces agglomerates with a D50 between 200 µm and 500 µm. Drying in a fluidized bed at inlet air 50–60°C is stopped at a moisture endpoint of 3.0–5.0%. The process window is narrow because residual moisture below 3.0% increases fines and segregation, while moisture above 5.0% causes twin-screw torque fluctuation and reduced granule hardness. Published data for the exact moisture-torque relationship in this specific formulation configuration is limited.
The extract grade is produced by aqueous ethanol extraction followed by low-temperature vacuum concentration and spray drying. Residual ethanol is controlled to ≤ 5,000 ppm under VICH GL18; methanol is controlled to ≤ 3,000 ppm and ethyl acetate to ≤ 5,000 ppm where process solvents are used. The injection sub-lot is further processed by diafiltration and adsorption to reduce endotoxin and water-insoluble particulates. Sterile filtration is performed through 0.45 µm and 0.22 µm polyethersulfone membranes under ISO 14644-1 Class 5 conditions. Terminal sterilization at 121°C for 15 min is acceptable for the extract grade only when the bergenin assay loss does not exceed 5.0%; above pH 7.0, marker degradation increases and solution color shifts from amber to dark brown. Published process-validation data for terminal sterilization of this specific extract are limited, so aseptic filtration is preferred for thermolabile batches.
For injectable manufacture, the extract is reconstituted in Water for Injection at 40–50°C, adjusted to pH 4.5–6.5 with citrate or phosphate buffer, and protected from light during processing. The reconstituted solution is checked for subvisible particulates using light obscuration; the acceptance limit for particles ≥ 10 µm is ≤ 25 per mL and for particles ≥ 25 µm is ≤ 3 per mL. These limits are tighter than oral-solution limits because the injection route bypasses gastrointestinal dilution. The extract should not be combined with strong alkaline buffers, strong oxidizing acids, or amine-based preservatives at elevated temperature, as such combinations accelerate polyphenolic oxidation and may generate visible precipitates.
Oral solutions and premixes require a different dispersion sequence. The extract is first wetted with 0.3% w/v sodium carboxymethylcellulose solution before high-shear mixing at 3,000 rpm for 10 min. This wetting step prevents floating extract agglomerates that otherwise reduce suspension homogeneity. For premix, the extract is adsorbed onto microcrystalline cellulose or lactose at a ratio of 1:3 before addition to the mineral carrier. Direct addition to mineral premix carriers without adsorption can produce segregation with a relative standard deviation above 5.0% after 10 min ribbon blending. Blend uniformity is tested using 10 sampling points and is considered acceptable when the bergenin assay relative standard deviation is ≤ 5.0%.
Compared with isolated bergenin monohydrate, the extract grade does not form a true solution at veterinary-relevant concentrations; it yields a polydisperse suspension. Isolated bergenin at the same marker dose may dissolve more readily, but it lacks the co-extracted flavonoids and triterpenoids retained in the herbal API. This difference changes formulation design: an oral solution of extract at 0.5% bergenin equivalent requires a suspending agent such as sodium carboxymethylcellulose at 0.3% w/v and a wetting agent to maintain a 24 h sedimentation volume ratio above 0.90. Isolated bergenin may require only pH adjustment and co-solvent addition. In capsules and tablets, the extract grade contributes non-marker solids that must be accounted for in the core weight; a 10 mg bergenin dose from the extract grade at 5.0% bergenin requires 200 mg extract per unit, whereas the same dose from isolated bergenin requires approximately 10 mg active compound.
Synthetic mucokinetic agents such as bromhexine hydrochloride are single chemical entities controlled at 99.0% or greater assay with related substances limits. The herbal API is standardized to bergenin as a marker, not as the sole active moiety; therefore its release includes botanical identity tests, marker assay, heavy metals, and microbial limits rather than a pure-compound related substances panel. This regulatory distinction explains why the veterinary herbal API is suitable for herbal premixes and traditional veterinary formulations, while isolated bergenin or synthetic drugs are preferred where exact molar dosing and narrow therapeutic indexing are required. For granule and solution dosage forms, the herbal API also requires additional stability controls because the non-marker fraction can affect moisture uptake, browning, and suspension viscosity at 40°C and 75% RH in accelerated stability studies.
In premix and granule feed applications, dispersibility is regulated more by particle surface polarity and hygroscopicity than by marker content alone. The extract grade at 45 µm D90 disperses uniformly in a standard feed premix carrier after adsorption to precipitated calcium carbonate at 1:2 by mass, giving a coefficient of variation of 4.8% in a 100 kg pilot batch when blended for 12 min in a double-ribbon mixer. The native grade can be blended directly into whole grain carriers, but it requires the same total aerobic count and mold limits to avoid microbial load build-up during storage at 25°C and 60% RH. Both grades should be protected from moisture and stored in sealed high-density polyethylene containers with desiccant when ambient relative humidity exceeds 60%.
