| HS Code | 570000 |
| Product Name | Banlangen Granules Veterinary Grade API |
| Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Api Category | Botanical Active Pharmaceutical Ingredient |
| Veterinary Grade | Yes |
| Botanical Source | Isatis tinctoria / Isatis indigotica root |
| Physical Form | Granules |
| Color | Brown to yellowish-brown |
| Odor | Characteristic herbal odor |
| Solubility | Freely soluble in water forming a colloidal solution |
| Particle Size | Over 90% passes through 20 mesh |
| Active Marker Compounds | Indigotin, indirubin, and Banlangen polysaccharides |
| Storage Conditions | Cool, dry, airtight, light-resistant container |
| Shelf Life | 24 months from date of manufacture |
As an accredited Banlangen 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 | Packaged in 25 kg sealed drums: Banlangen Granules veterinary-grade API for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Container Loading (20′ FCL) | 20′ FCL container loaded with Banlangen Granules Veterinary Grade API, properly palletized, sealed, and secured for safe transport. |
| Shipping | This veterinary-grade API is shipped in sealed, moisture-resistant containers to preserve granule integrity. Handling requires cool, dry conditions away from direct sunlight. International transport complies with pharmaceutical safety regulations, with complete documentation for customs. Proper labeling ensures safe storage and suitability for manufacturing tablets, injections, capsules, powders, granules, premixes, or solutions. |
| Storage | Store Banlangen Granules Veterinary Grade API in a cool, dry, well-ventilated area. Keep away from moisture, direct sunlight, and heat sources. Preserve in tightly closed, original containers, protected from cross-contamination. Ensure proper labeling and secure storage to restrict unauthorized access. Follow local regulations and product-specific guidance for handling, hygiene, and disposal. |
| Shelf Life | Shelf life is 24 months under proper storage in a cool, dry, sealed container, protected from light and moisture. |
In commercial broiler and layer integrations, the water-soluble powder route remains the primary mass-administration format when flock-level support is required during the first 7 days after placement and after transport stress. The Banlangen Granules Veterinary Grade API used in this pathway is released against the Veterinary Pharmacopoeia of the People’s Republic of China 2020 Banlangen monograph, with identity verified by thin-layer chromatography against epigoitrin and indirubin reference standards. Facilities handling the material must operate under veterinary GMP principles aligned with ISO 22000:2018 clause 8.5.1 for hazard control planning and 21 CFR Part 211 for cross-contamination prevention when the material is blended as a medicated drinking-water product. The working addition ratio in finished drinking water is typically 0.5–1.0 g of extract per 1 L of solution, equivalent to 500–1000 g per 1000 L header tank volume, with the lower bound used in birds over 28 days and the upper bound reserved for acute flock-level challenge under veterinary direction. In production, the dry extract and dextrose monohydrate are blended in a ribbon blender at 120 rpm for 15 minutes, then transferred to a fluid-bed granulator where a 10% w/w aqueous binder is sprayed at 55–65 °C inlet air temperature, 35–40 °C exhaust temperature, and 80–120 mL/min spray rate. The resulting granulate is passed through an 80-mesh screen and dried to a moisture content of no more than 3.0% w/w to prevent caking during storage. For free-flowing water-soluble powders, sodium citrate dihydrate is incorporated at 1.0–2.0 wt% and silicon dioxide at 0.3–0.5 wt% as anti-caking agents. A known production bottleneck is bridging of the spray-dried extract in the dispensing hopper when relative humidity exceeds 60%; therefore, pre-drying at 45 °C for 2 hours and climate-controlled dispensing at or below 35% RH are required. The terminal finished product types in this application segment are 100 g, 500 g, and 1 kg water-soluble powder sachets and 5 kg bulk packs for proportional dosing through drinking-water medicators.
The limiting step in manufacturing a stable Banlangen premix for swine is not extraction yield but the control of particle size distribution and hygroscopic bridging during micro-dosing. In EU member states, the material is classified as a feed material under Regulation (EU) No 68/2013, not as a zootechnical additive under Regulation (EC) No 1831/2003; placement therefore requires feed hygiene compliance under Regulation (EC) No 183/2005 and GMP+ BA4 feed safety assurance, with HACCP verification to ISO 22000:2018 clause 8.5.1. The addition ratio in complete feed ranges from 2 kg to 5 kg per tonne, with 2–3 kg/tonne used in sow lactation rations and 4–5 kg/tonne used in nursery creep feed under veterinary prescription in jurisdictions where the extract is authorized as a complementary feed material. A loss-in-weight micro-doser must be calibrated for a feed factor of 0.95–1.02 because bulk density of the spray-dried API typically ranges between 0.38 g/cm³ and 0.52 g/cm³; volumetric auger systems without mass feedback create batch-to-batch coefficients of variation above 10%. The preferred mixing train is a twin-shaft paddle mixer with a working volume of 1000 L, operating at 45–50 rpm for 180–240 s after the premix is added. Blend uniformity testing is conducted using a USP <905> sampling protocol with 10–12 sampling points, accepting a relative standard deviation of no more than 5.0% for total polysaccharide content. Downstream pelleting must keep conditioner temperature below 65 °C because moisture and heat accelerate browning reactions between reduced sugars in the carrier and nitrogenous alkaloids in the extract; finished pellet moisture should be no more than 12.0% w/w. The terminal finished product types are 5 kg and 25 kg medicated premix sacks, 2.5% concentrated creep feed premixes, and sow top-dress supplements.
When oral drenches are compared with in-feed delivery in ruminant production systems, the decision is driven by ruminal retention time, the avoidance of feed refusal in stressed calves, and the need for individual animal dosing rather than group-level exposure. The Banlangen Granules Veterinary Grade API for oral solutions is generally formulated as a 5.0–10.0% w/v aqueous extract solution with a dose of 5–10 mg total extract solids per kg body weight per day, administered for 3–5 consecutive days. The exact addition ratio in the finished product is determined by target dose volume, with a 100 mL bottle containing 5.0–7.5 g of extract when the dose is 1 mL per 10 kg body weight. The production process starts with purified water heated to 40–45 °C, into which the extract is added under a high-shear disperser with a tip speed of 10–15 m/s for 20 minutes. The pH is adjusted to 5.8–6.2 using 0.1 M citric acid or 0.1 M sodium hydroxide to prevent precipitation of the polysaccharide fraction, and the solution is passed through a 0.45 µm polyethersulfone membrane filter to remove insoluble plant mucilage. Sodium benzoate at 0.1% w/v and potassium sorbate at 0.1% w/v are dissolved before final volume adjustment. Regulatory compliance for this route in the EU falls under Regulation (EU) 2019/6 on veterinary medicinal products, with stability data generated according to VICH GL18 residual solvent requirements and VICH GL3 stability testing where the product is registered as a veterinary herbal preparation. The receiving farm must maintain the solution in a closed container at 15–25 °C and use it within 48 hours after first opening unless the formulation contains a preservative system validated by challenge testing. The terminal finished product types are 100 mL and 500 mL oral drench bottles, 1 L bulk oral solution packs for pump dosing, and 5 L mixing packs for automatic milk replacer proportioners.
Compaction of a high-hygroscopicity botanical extract into a 150–300 mg oral solid dosage form for companion animals requires the granulation endpoint to be specified by moisture and particle size rather than by visual appearance; otherwise, the tablet press will exhibit sticking, capping, and unacceptable weight variation. For tablets, the Banlangen Granules Veterinary Grade API is incorporated at 10.0–20.0 wt% of the core, with the remaining mass composed of microcrystalline cellulose, lactose monohydrate, crospovidone at 2.0–4.0 wt%, and magnesium stearate at 0.5–0.75 wt%. For capsules, the extract is often dry-blended with pregelatinized starch at a 1:1 ratio to obtain a fill weight of 300–500 mg. The granulation process uses a high-shear mixer with impeller speed of 250–300 rpm and chopper speed of 1500–2000 rpm for 3–5 minutes after adding a 5.0% w/w PVP K30 aqueous binder. The wet mass is dried in a fluid-bed dryer at 55–60 °C until loss on drying reaches 2.0–3.0% w/w, then passed through a 0.8 mm screen. Compression is performed on a rotary tablet press at 10–15 kN with a compression speed of 30–50 rpm. The tablet hardness target is 80–120 N, and disintegration time is controlled to no more than 15 minutes according to USP <701>. The relevant standards for the finished companion animal product include USP <905> for content uniformity, USP <711> for dissolution using 900 mL of pH 6.8 phosphate buffer at 37 °C with paddle speed of 50 rpm, and USP <561> for botanical identity. The terminal finished product types are 100 mg and 200 mg extract tablets in aluminum/PVC blister packs, and 150 mg extract capsules in HPMC shells with a shelf life of 24 months under 25 °C/60% RH storage conditions.
The production of an injectable grade from a crude botanical extract is constrained by the need to remove high-molecular-weight polysaccharide aggregates, denature residual proteins, and reduce endotoxin load to a limit compatible with parenteral administration; this process is significantly more complex than the oral powder pathway and requires separate dedicated equipment to prevent cross-contamination. The Banlangen extract for injection is typically dissolved at 0.5–1.5% w/v total solids in water for injection at 35–40 °C, then subjected to ultrafiltration through a 10 kDa polyethersulfone membrane cassette to remove potential antigenic polysaccharide aggregates. The filtrate is treated with 0.1% w/v activated carbon for 20 minutes at 40 °C to reduce bacterial endotoxin, followed by 0.22 µm sterilizing filtration through a polyvinylidene fluoride cartridge with a rated throughput of 10–15 L/m²/h. The solution is aseptically filled into depyrogenated Type I glass vials under nitrogen overlay. The absence of terminal steam sterilization is justified only if the filtration is validated for each batch because the heat-labile indirubin marker degrades by more than 10% when held at 121 °C for 15 minutes. The addition ratio is deliberately kept at the lower end of the range when the injectable is intended for intravenous administration in small animals, while the upper end is reserved for intramuscular use in large animals under veterinary supervision. The relevant compliance matrix includes USP <85> for bacterial endotoxins, USP <788> for particulate matter, and the Veterinary Pharmacopoeia of the People’s Republic of China 2020 injection monograph for sterility and pH. Residual solvent testing under VICH GL18 is often limited to ethanol and methanol if alcohol precipitation was used during extraction.
| Quality attribute | Acceptance limit | Method/standard |
|---|---|---|
| Bacterial endotoxins | ≤0.25 EU/mg | USP <85> |
| Particulate matter ≥ 10 µm | ≤6,000 particles/container | USP <788> |
| Particulate matter ≥ 25 µm | ≤600 particles/container | USP <788> |
| Sterility | No growth after 14 days | VPPRC 2020 injection monograph |
| pH | 5.5–6.5 | USP <791> |
The terminal finished product types in the injectable segment are 10 mL and 50 mL sterile vials, 100 mL multi-dose vials with 0.5% w/v benzyl alcohol as preservative, and 5 mL pre-filled syringes for companion animal use under emergency veterinary supervision.
Top-coated aquafeed pellets containing Banlangen extract present a different stability problem from dry premixes: the lipid coating layer becomes the primary oxygen barrier, but it also creates a route for moisture entrapment at the pellet surface if the coating solidifies too rapidly. In this application, the Banlangen Granules Veterinary Grade API is applied at 3–8 g per kg of extruded feed, with the higher end used for shrimp nursery feeds and the lower end used for grow-out fish feeds. The production sequence begins after extrusion and drying of the base pellet to 8.0–10.0% w/w moisture. The extract is dispersed in a mixture of fish oil and soy lecithin at 2.0–4.0 wt% of the total feed mass, then applied in a vacuum coater operating at 0.4–0.6 bar vacuum for 15–20 minutes. The coating layer is allowed to set at 25 °C for 2 hours before packaging. Published data for specific Banlangen aquafeed leaching kinetics is limited; therefore, the coating integrity in water must be verified batch-wise by measuring total polysaccharide loss after 30 minutes of immersion in 28–30 °C seawater or freshwater at the target farm system. Compliance in this segment is governed by feed hygiene requirements under ISO 22000:2018 clause 8.5.1 and HACCP, with the material excluded from the EU Register of Feed Additives; any therapeutic claim must be supported by local aquaculture veterinary authorization. The terminal finished product types are 2 mm extruded floating pellets for freshwater fish, 3 mm sinking shrimp feed, and 0.8 mm micro-pellets for larval nursery systems.
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Banlangen Granules Veterinary Grade API is a standardized botanical extract prepared from the dried root of Isatis indigotica Fort., produced as a free-flowing brown to dark brown granule or fine powder for use solely as an active pharmaceutical ingredient in veterinary medicinal products. It is intended for downstream incorporation into tablets, injections, capsules, powders, granules, premixes, and oral solutions. The material is not a finished veterinary drug and is not released for direct administration without formulation, batch testing, and registration-specific release. The product model is a manufacturer-assigned identifier, not a compendial designation; the model code often distinguishes spray-dried powder from wet-granulated intermediate and may encode the nominal extraction ratio or dosage-form compatibility class. No universal model system exists, so purchase specifications must state the manufacturer’s model number and the corresponding certificate of analysis. Standardization is performed by high-performance liquid chromatography against marker constituents of Isatis indigotica root, typically the indigo/indirubin fraction and, where the registered specification requires, total alkaloid content calculated as epigoitrin on a dried basis. Because the raw root material varies with harvest season, geographic origin, and storage interval, the manufacturer’s registered specification is the controlling document for lot-to-lot acceptance.
Release testing follows the veterinary drug registration dossier, with analytical methods aligned to pharmacopoeial general chapters and ISO/IEC 17025 for laboratory competence. Identity is confirmed by thin-layer chromatography or HPLC retention-time matching against a certified Banlangen reference extract. Assay limits are expressed as marker content; if total alkaloid content is included, the result is calculated as epigoitrin on a dried basis. Chromatographic separation uses a C18 stationary phase with 5 µm particle size and a 150 mm × 4.6 mm internal diameter column. Loss on drying, total ash, and heavy metals are controlled because the aqueous extract is hygroscopic and may concentrate soil-derived elements during extraction. Microbial limits include total aerobic microbial count, total combined yeast and mold count, and absence of Escherichia coli and Salmonella species. For injection-grade material, a bacterial endotoxin limit is added to the specification; the exact limit is stated in the finished product registration and is not universal across all dosage forms.
| Parameter | Typical acceptance criterion | Reference framework |
|---|---|---|
| Appearance | Brown to dark brown granules or powder, free from visible foreign matter | Veterinary drug registration file |
| Identification | HPLC retention time matches Banlangen reference extract | Chinese Veterinary Pharmacopoeia, where applicable |
| Loss on drying | ≤5.0% | Pharmacopoeial general chapter |
| Total ash | ≤5.0% | Pharmacopoeial general chapter |
| Heavy metals | ≤10 mg/kg | Pharmacopoeial general chapter for botanical APIs |
| Arsenic | ≤2 mg/kg | Pharmacopoeial general chapter |
| Total aerobic microbial count | ≤1000 CFU/g | Pharmacopoeial microbial limits |
| Total combined yeast and mold count | ≤100 CFU/g | Pharmacopoeial microbial limits |
| Marker assay | Not less than the label claim; product-specific | HPLC-DAD or HPLC-UV |
The values listed above are commonly encountered release limits for botanical extract APIs and are not a substitute for the registered specification. Where a finished product is intended for injection, the API specification also includes bacterial endotoxins, particulate matter after reconstitution if applicable, and sterility of the final filtered solution if required by the finished dosage form.
Dry blending precedes tablet compression and capsule filling. Banlangen extract granules are milled until not less than 90% passes through a 60-mesh sieve, then blended with diluents, disintegrants, and lubricants. Direct compression is feasible only when the loss-on-drying result is below the registered limit and ambient relative humidity is below 60%; above that threshold, pre-drying in a fluidized-bed dryer or tray dryer at product temperature not exceeding 60°C restores flow and reduces sticking. Wet granulation with aqueous binder solution may be used, but the binder addition rate is controlled to avoid partial solubilization of the extract; excessive water produces hard agglomerates and slow tablet disintegration. During tablet compression, tooling sticking is minimized by using low-moisture granulation and, where compatible, 0.5% to 1.0% magnesium stearate by weight. If the extract contains residual polysaccharide moisture, ejection force increases and tablet capping in high-speed presses is observed.
For capsules, the milled blend is filled on an intermittent-motion capsule machine or a continuous dosator-type machine. Fill weight uniformity is monitored according to the pharmacopoeial uniformity of dosage units method. For oral solutions and injectable solutions, the granular API is dissolved in purified water or water for injection with mechanical stirring at 40°C to 50°C; the temperature is not raised above 60°C because the marker compounds are heat-labile. The solution is passed through a 0.45 µm clarifying membrane before final sterile filtration through a 0.22 µm membrane for injectable preparations. When the API is specified for injectable solutions, it must meet the bacterial endotoxin limit established in the finished product registration and be dissolved in water for injection. Terminal sterilization by autoclaving is not automatically acceptable because heat may reduce marker content; if terminal sterilization is used, stability-indicating assays are required to demonstrate marker recovery after the cycle. For premixes, the API is dispersed onto a feed carrier such as corn gluten meal or calcium carbonate; mixing uniformity is validated in the registration file. For powders and granules for sachets, the API is blended with a flow aid and filled under low-humidity conditions.
The polysaccharide fraction of Banlangen extract is water-soluble and contributes to solution viscosity. At reconstitution concentrations above 10% w/v, viscosity increases nonlinearly and can complicate filterability through 0.22 µm membranes. Filterability is therefore tested on the finished solution using a constant-pressure apparatus; a pre-filter with nominal pore size of 0.45 µm is used to reduce membrane fouling. For tablet formulations containing more than 20% by weight of the API, disintegration time can exceed 15 minutes unless a disintegrant such as crospovidone or sodium starch glycolate is included at 3% to 5% of tablet weight. The aqueous solubility of the extract is pH-dependent; below pH 3.0 the polysaccharide fraction can precipitate and reduce the effective marker concentration in solution. Therefore, pH adjustment for oral solutions is performed after the extract is fully dispersed, and acidic buffer systems are compatibility-tested before use.
Spray drying is used to convert the aqueous extract into a free-flowing powder. The extract is pumped to a rotary atomizer or two-fluid nozzle at feed solids concentrations from 15% to 25% w/w. At higher solids, the feed viscosity exceeds the atomizer design range and the resulting powder bulk density increases beyond the target for aqueous dissolution. Inlet air temperature is maintained between 160°C and 180°C, while outlet air temperature is held between 70°C and 85°C. The product temperature remains below 60°C to limit degradation of epigoitrin. On production-scale spray dryers with cyclone recovery, fine particle entrainment reduces yield; installation of a bag filter downstream is used to recover fines and reduce dust emission.
Fluidized-bed top-spray granulation is selected when the API is required as a directly compressible granule. Inlet air temperature is controlled between 60°C and 75°C, product temperature between 35°C and 45°C, and spray rate is adjusted to maintain bed relative humidity below 55%. If the spray rate exceeds the evaporation capacity of the inlet air, localized overwetting forms hard agglomerates and nonuniform marker distribution. The air distribution plate open area and granulator bowl L/D ratio influence fluidization; no universal settings apply, and scale-up must be verified with a trial batch. Twin-screw wet granulation is less common for this extract because the high polysaccharide content can create a sticky mass at low water levels; where used, screw speed and barrel temperature are kept low to avoid thermal degradation.
Scale-up from pilot to production spray dryer is sensitive to exhaust air capacity. If the production dryer exhaust fan cannot maintain the target outlet temperature at the selected feed rate, product temperature rises and marker loss increases; therefore feed rate is reduced or inlet temperature is lowered. The use of a rotary atomizer at 15,000 to 25,000 rpm is typical for pilot units, but production units may require lower rotation to reduce fines; droplet size affects both bulk density and dissolution rate. Published data for this specific configuration is limited, and registration trial batches determine the final ranges.
Human-grade Banlangen formulations are released under the Chinese Pharmacopoeia or related human OTC monographs and are usually finished granules containing sucrose, dextrin, or both. Veterinary-grade Banlangen API must satisfy veterinary drug registration and food-producing animal residue avoidance criteria, and is supplied without added excipients unless a premix carrier is specified. Crude root powder differs from the API in marker content, particle size, and water solubility. Crude powder contains the intact plant matrix; the API is an aqueous or hydroalcoholic extract that has been dried and standardized. Extraction removes most of the fiber matrix and reduces soil-derived elements, but it concentrates water-soluble polysaccharides, alkaloids, and oligosaccharides. In tablet granulation, this concentrated polysaccharide fraction increases wet mass viscosity and can slow tablet disintegration; in solutions, the water-soluble fraction is beneficial but may precipitate under acidic conditions or high ionic strength.
| Attribute | Veterinary-grade API | Human-grade Banlangen granules | Crude Banlangen root powder |
|---|---|---|---|
| Compendial status | Manufacturer veterinary drug registration | Chinese Pharmacopoeia/human OTC monograph | Raw material monograph |
| Dosage-form suitability | Tablets, injections, capsules, powders, granules, premixes, solutions | Finished oral granule | Decoctions and feed ingredient |
| Excipient content | None unless specified | Sucrose, dextrin, or both | None |
| Marker standardization | HPLC marker claim | Not always standardized | Unstandardized, harvest-dependent |
| Microbial/endotoxin control | API release plus endotoxin where injection-grade | Finished-product limits | Minimal; requires further processing |
| Particle size | Milled or granulated to defined sieve cut | Finished granule size | Coarse botanical powder |
Unlike single-entity synthetic antiviral APIs such as amantadine hydrochloride or oseltamivir phosphate, Banlangen API is a multi-component botanical product. Its activity cannot be expressed as a single molar dose; batch consistency relies on chromatographic fingerprinting and marker-content ratios rather than a single stoichiometric assay. This difference affects dissolution testing because the marker release profile may not represent the entire product weight; dissolution methods are therefore finished-product specific and are not automatically required by the API specification. In feed premixes, the marker is extracted from the feed matrix before HPLC analysis, and method recovery correction factors are established during analytical validation. Substitution of a synthetic antiviral on a weight-for-weight basis is not appropriate and is not supported by the compendial framework.
Veterinary API supply is controlled under the Ministry of Agriculture and Rural Affairs veterinary drug registration framework and Veterinary Good Manufacturing Practice. A certificate of analysis alone is insufficient; the documentation package includes the manufacturing process description, extraction solvent declaration, residual solvent report, pesticide residue statement, and stability summary. Solvent residues are controlled according to VICH GL18 where applicable; if ethanol is used in extraction, residual ethanol is reported and limited. For food-producing animals, withdrawal period data are generated for the finished product, but the API manufacturer may be required to provide batch data to support depletion studies. Importing jurisdictions may require technical documentation under Regulation (EU) 2019/6 or national phytochemical requirements; published data for specific jurisdictional acceptance of this veterinary-grade Banlangen configuration is limited. The material is not automatically interchangeable with a human-grade Banlangen extract because residual solvent, microbial, and documentation requirements differ.
Stability protocols for the API include accelerated storage at 40°C ± 2°C and 75% ± 5% relative humidity for screw-capped HDPE containers; testing at 0, 1, 2, 3, and 6 months covers appearance, moisture, marker assay, and microbial limits. If the container is not moisture-tight, moisture gain can exceed 5.0% within 4 weeks, causing granule agglomeration. For long-term storage, 25°C ± 2°C at 60% ± 5% relative humidity is the conventional condition; registered stability data may differ.
Batch-to-batch control begins at raw root intake. The extraction ratio is adjusted to the major marker assay of the input root lot; root lots with lower marker content require a higher extraction ratio, which increases the final polysaccharide content and may reduce tablet hardness or raise solution viscosity. Drying yield varies with feed solids and inlet air temperature; if outlet humidity is not controlled, the powder may agglomerate in the cyclone and require re-milling. Sieve analysis after drying rejects oversize granules. The finished API is packaged in food-grade polyethylene double bags inside a fiber drum, and the label carries the manufacturer’s model code, batch number, production date, and storage instruction. Storage is maintained in a dry warehouse below 30°C and protected from light.
