| HS Code | 979880 |
| Product Name | Banlangen Powder Veterinary Grade API |
| Product Type | Botanical active pharmaceutical ingredient (API) |
| Source Material | Root of Isatis tinctoria L. (Radix Isatidis) |
| Extract Type | Water-soluble concentrated extract powder |
| Active Marker | R,S-goitrin and indican |
| Appearance | Yellowish-brown to brown homogeneous powder |
| Odor | Slight characteristic herbal odor |
| Solubility | Soluble in water; suitable for aqueous solution and injection formulations |
| Particle Size | 95% minimum through 80 mesh |
| Shelf Life | 24 months in unopened original packaging |
| Storage | Store sealed in a cool, dry place away from direct sunlight |
| Compatible Formulations | Tablets, injections, capsules, powders, granules, premix, and solutions |
As an accredited Banlangen Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Sealed, moisture-proof packaging available in 1 kg, 5 kg, 10 kg, or 25 kg quantities for safe veterinary API storage. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Banlangen Powder veterinary grade API: packed in sealed drums, palletized, ventilated, secured for safe transport. |
| Shipping | Banlangen Powder Veterinary Grade API is shipped in sealed moisture-proof double polythene bags inside fiber drums or aluminum foil pouches. Store in a cool, dry place away from sunlight. Transport via air, sea, or express courier with complete documentation. Non-hazardous, but handle gently to prevent package damage. |
| Storage | Store Banlangen Powder (Veterinary Grade API) in a cool, dry, well-ventilated area at controlled room temperature, ideally below 25°C. Keep the container tightly sealed and protected from direct sunlight, moisture, and strong odors. Avoid exposure to excessive heat or humidity. Use clean, dry equipment when handling to prevent contamination and preserve potency. |
| Shelf Life | Shelf Life: 24 months when stored in a cool, dry, airtight environment, protected from light, moisture, and contamination. |
Water-soluble powder formulations intended for flock-level administration via drinking water generally employ Banlangen Powder Veterinary Grade API at 10–30 g per 100 g of finished powder, diluted at point of use to 0.5–1.0 g per litre of drinking water. The downstream process begins with sifting the extract through a 60-mesh stainless-screen sifter to remove hard agglomerates, followed by dry blending in a 500 L ribbon mixer with anhydrous dextrose, citric acid, and anticaking agent until near-infrared blend uniformity reaches a relative standard deviation ≤5.0%; mixing time typically runs 8–12 minutes at 60–80% working volume. Ambient relative humidity during sachet filling is maintained at ≤40% because the extract powder absorbs moisture above 60% RH, producing darkened granules and reduced flow; if excursions occur, pre-drying at 40–45°C for 2–4 hours is applied. Final powder moisture is controlled to ≤4.0% w/w as an internal release limit under current veterinary GMP expectations aligned with Regulation (EU) 2019/6, with validated cleaning procedures to prevent cross-contamination on shared lines. Terminal finished products include 100 g, 500 g, and 1 kg aluminium-laminated sachets or HDPE containers intended for dilution into poultry drinking systems.
Aqueous concentrate for injectable presentation is prepared at 10–20 mg total extract solids per mL and later sterile-filtered or terminally sterilised depending on heat-stability studies. The production process includes dissolution in Water for Injections at 60–70°C, addition of 0.1–0.3% w/v activated carbon for decolorisation and pyrogen reduction, and pH adjustment to 6.5–7.5 with 0.1 M sodium hydroxide or hydrochloric acid. Sterile filtration uses a 0.45 µm polypropylene prefilter and a 0.22 µm PVDF sterilising membrane; extracts with a high polysaccharide fraction can reduce cumulative filter throughput by more than 40% after 3,000 L/m², but published membrane-specific throughput data for this exact extract configuration is limited and filterability trials on each batch are required. When terminal steam sterilisation is selected, filled vials are autoclaved at 121°C for 15 minutes; otherwise aseptic filling under EU GMP Annex 1 (2022) applies. Release testing includes sterility by Ph. Eur. 2.6.1, bacterial endotoxins by Ph. Eur. 2.6.14, and sub-visible particulate matter by Ph. Eur. 2.9.19. Finished products are 10 mL, 50 mL, and 100 mL type II glass vials with bromobutyl rubber closures.
Ready-to-use oral solutions for neonatal calves and lambs are prepared at 20–50 mg/mL total Banlangen extract solids in purified water, with 10–20% v/v sorbitol or glycerin to suppress precipitation and 0.05–0.10% w/w potassium sorbate plus 0.05–0.10% w/w sodium benzoate as preservative. The manufacturing sequence involves dissolving the API in heated purified water at 55–65°C, cooling to 20–25°C, adding buffering agents to pH 5.5–6.5, and clarifying through a 5 µm polypropylene depth filter before filling into 100 mL, 250 mL, and 1 L HDPE bottles with dosing pumps or tamper-evident closures. Release tests include microbial enumeration under Ph. Eur. 5.1.4 and preservative efficacy under Ph. Eur. 5.1.3; visible precipitation after refrigeration at 2–8°C is a known physical instability and must be controlled by co-solvent selection. Terminal finished product types are oral drench solutions for calves, lambs, and goat kids administered via calibrated dosing gun.
For high-dose tablets and ruminant boluses, wet granulation is required because Banlangen Powder Veterinary Grade API displays a Carr index above 30% in bulk form and does not flow uniformly through direct compression tooling at high loadings. The formulation combines 30–50% w/w API with microcrystalline cellulose, dibasic calcium phosphate, and 10–15% w/w pregelatinised starch, then granulates with 3–4% w/w purified water or a suitable binder. Granules are dried to loss on drying 2.5–4.0% w/w, screened through 0.8 mm, lubricated with 0.5% w/w magnesium stearate, and compressed on a 16-station rotary tablet press at 10–20 kN main compression force to achieve tablet breaking force of 60–100 N; larger boluses are compressed on a hydraulic press at 25–50 kN. Release testing includes disintegration according to USP <701>, uniformity of dosage units by Ph. Eur. 2.9.40, and tablet breaking force by USP <1217>. Finished products are 500 mg and 1,000 mg tablets, and 3–15 g boluses for cattle and equine oral administration.
In oral granule production for suckling and weaned swine, Banlangen Powder Veterinary Grade API is incorporated at 20–40% w/w of the final granule mass to compensate for variable native extract assay while preserving acceptable palatability. The manufacturing process uses high-shear granulation with 3–5% w/w povidone K30 solution or equivalent binder, followed by fluid-bed drying at inlet air temperature 50–60°C, product temperature 35–45°C, and spray rate 2–4 kg/h through a 1.0 mm nozzle. Dried granules are sieved; release requires ≥90% particle fraction between 0.180 mm and 1.000 mm, loss on drying ≤3.0% w/w, and bulk density 0.45–0.60 g/cm³ to ensure consistent volumetric filling. Compliance for this dosage form follows the granule monograph of the Chinese Veterinary Pharmacopoeia 2020 where applicable for the target market, with batch records aligned to current veterinary GMP. Terminal packages include 50 g and 100 g aluminium sachets, plus 20 kg HDPE pails for on-farm mixing; granules are administered either directly or after dissolution in 1–2 L of water.
In companion animal capsule production, the extract’s moisture uptake above 55% RH makes low-humidity suites mandatory. The standard formulation loads 50–200 mg Banlangen Powder Veterinary Grade API per capsule into hydroxypropyl methylcellulose or hard gelatin shells, dry-blended with lactose monohydrate, 0.5–1.0% w/w colloidal silicon dioxide, and 0.3–0.5% w/w magnesium stearate. Encapsulation on a 30-station tamping pin machine uses tamping settings adjusted to 5–10 mm slug height, with periodic fill weight checks against Ph. Eur. 2.9.40 uniformity of dosage units; disintegration is tested by Ph. Eur. 2.9.1, and Karl Fischer moisture release limit is ≤6.0% w/w. Hard gelatin shells may exhibit splitting at relative humidity below 30%, while HPMC shells preferentially reduce hygroscopic sticking at higher fill weights. Finished products are 60, 100, and 250 capsule HDPE bottles or aluminium/PVC blister packs.
Because botanical extract API tends to segregate when blended directly into final compound feed, medicated premix production for poultry and swine employs a two-stage dilution. The primary premix incorporates 5–10% w/w Banlangen Powder Veterinary Grade API onto ground maize cob, wheat bran, or precipitated silica in a horizontal ribbon mixer operating at 30–50 rpm for 10–15 minutes; homogeneity acceptance is a coefficient of variation ≤5.0% across 10 sampling points. The validated primary premix is then diluted to a final feed inclusion of 1.0–5.0 kg per tonne in a second mixing stage, with bulk density variation between API lots of more than ±15% requiring recalibration of the volumetric metering device. Premix production follows Regulation (EC) No 183/2005 for feed hygiene and Directive 2002/32/EC for undesirable substances; medicated feed status additionally triggers Regulation (EU) 2019/6. Terminal finished products include 25 kg paper bags or 1,000 kg bulk bags of premix, and final compound feed containing the diluted premix.
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The Banlangen Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a spray-dried aqueous extract of Isatis indigotica root supplied under model codes BLG-VAPI-2025-P1 for dry oral dosage manufacturing and BLG-VAPI-2025-P2 for liquid and injectable production. The material is a brownish-yellow to dark brown powder with a characteristic faint odor, produced by hot-water extraction, concentration, and spray drying without maltodextrin carrier. Silicon dioxide is permitted as an anticaking agent at not more than 0.5% w/w. Release specifications include loss on drying not more than 5.0%, total ash not more than 5.0%, acid-insoluble ash not more than 0.5%, heavy metals not more than 10.0 mg/kg, arsenic not more than 2.0 mg/kg, and total aerobic microbial count not more than 1,000 CFU/g for P1 or 100 CFU/g for P2, with absence of Escherichia coli and Salmonella in both grades. HPLC-UV assay for (R,S)-goitrin is controlled at 0.10–0.40% on the dried basis, and adenosine is controlled at 0.05–0.15%. The powder is intended solely as an active pharmaceutical ingredient for further veterinary drug product manufacture; it is not presented as a sterile API, and P2 requires downstream aseptic filtration or terminal sterilization. Final dose and combination are fixed by the registered drug product.
Particle size is adjusted during spray drying by nozzle atomization and in-line cyclone classification. P1 complies with a D90 limit of 75 µm by laser diffraction according to ISO 13320:2020; P2 is micronized or air-classified to D90 not more than 25 µm. Bulk density ranges from 0.35 to 0.55 g/cm³ for P1 and 0.30 to 0.48 g/cm³ for P2. These ranges are established from three consecutive production campaigns on a 500 kg batch size spray dryer with inlet air temperature 160–180 °C and outlet air temperature 70–85 °C. P1 has a Hausner ratio of 1.18–1.25 and Carr index of 20–25, which supports direct compression and capsule filling. P2 shows higher surface-energy hygroscopicity; opened containers should be resealed with desiccant when ambient relative humidity exceeds 60%.
Injectable dosage forms require controlled endotoxin and particulate matter burdens but also require reconstitution behavior that does not generate sub-visible aggregates. The P2 grade is specified with a bacterial endotoxin release limit of 0.50 EU/mg by kinetic chromogenic LAL assay. This limit is intended to support downstream formulation where the final injectable volume and maximum dose are established by the product dossier. Because the API is not sterile, drug product manufacture must include terminal sterilization or aseptic filtration. Terminal moist-heat sterilization at 121 °C for 15 min can increase absorbance at 450 nm by 0.15–0.30 AU and may generate sub-visible precipitates from heat-sensitive polysaccharides. Aseptic filtration is therefore the preferred downstream route for P2-based injections.
Dissolving P2 in water for injection at 5.0% w/v yields a dark amber opalescent liquid with pH 5.5–6.5 and conductivity 800–1,200 µS/cm. Sub-visible particulate matter after reconstitution and filtration is assessed according to CPV 2020 General Chapter 0902. The recommended filtration train is a 0.45 µm polyethersulfone prefilter followed by a 0.22 µm PES membrane, sized at not less than 0.5 m² per 100 L of 5.0% w/v batch. Filtration pressure differential should not exceed 1.0 bar. Flux decline observed in production-scale filtration is attributed to high-molecular-weight polysaccharide fractions. Published data for this specific configuration is limited, so filter compatibility and flux trials are mandatory before scale-up.
Formulators should avoid pH below 3.0 because acidic polysaccharide fractions precipitate, and pH above 9.0 accelerates hydrolysis of the sulfur-containing marker (R,S)-goitrin. High-shear mixing of P2 solutions may also generate foam; silicone-based defoamers should be tested because they can reduce membrane filterability. The injectable grade is distinguished from the oral grade by lower bioburden, endotoxin control, and controlled sub-visible particulate behavior, not by a different active-marker content.
Banlangen powder is differentiated from crude root powder by normalized marker content, controlled particle size, and lower microbial burden. The table compares the two model grades with unprocessed root powder.
| Parameter | Method or standard | BLG-VAPI-2025-P1 | BLG-VAPI-2025-P2 | Crude root powder |
|---|---|---|---|---|
| Loss on drying | CPV 2020 General Chapter 0832 | ≤5.0% | ≤5.0% | ≤12.0% |
| Total ash | CPV 2020 General Chapter 2302 | ≤5.0% | ≤5.0% | ≤10.0% |
| Particle size D90 | ISO 13320:2020 | ≤75 µm | ≤25 µm | 250–850 µm |
| (R,S)-goitrin | HPLC-UV internal method | 0.10–0.40% | 0.10–0.40% | 0.02–0.08% |
| Adenosine | HPLC-UV internal method | 0.05–0.15% | 0.05–0.15% | 0.01–0.05% |
| Total aerobic microbial count | CPV 2020 General Chapter 1105 | ≤1,000 CFU/g | ≤100 CFU/g | ≤10,000 CFU/g |
| Bacterial endotoxins | CPV 2020 General Chapter 1143 | Not specified | ≤0.50 EU/mg | Not specified |
The marker normalization is achieved by blending extract batches to a target (R,S)-goitrin content before spray drying. This is a key difference from raw root powder, where marker variability can exceed ±40% across harvest origins. For low-dose tablet and premix formulations, this reduces assay adjustment at the drug product stage. Water-dispersible solids are controlled at not less than 85% for P1 and 90% for P2 using an internal wet-sieving method through a 75 µm screen.
On a 12-station rotary tablet press, blends containing 25% w/w BLG-VAPI-2025-P1, microcrystalline cellulose PH102, lactose monohydrate, and croscarmellose sodium at 3.0% w/w produced 500 mg tablets with hardness 60–90 N and friability below 0.8% when compressed at 6–12 kN. Content uniformity testing per CPV 2020 General Chapter 0941 gave (R,S)-goitrin RSD below 2.0% across three validation batches. For hard gelatin capsules, the same P1 grade filled at 30,000 capsules/h on an automatic dosing disc machine maintained weight variation below ±5.0%. Formulations containing more than 40% w/w of the extract required dry granulation because the spray-dried powder compacts poorly under direct compression at high loading. Roller compaction at 5–8 kN/cm roll pressure increased bulk density to 0.45–0.55 g/cm³ while preserving tablet hardness.
Premix manufacture at 2–5% API inclusion in corncob or calcium carbonate carrier achieved a coefficient of variation below 5.0% after 10 min of ribbon mixing. If the premix is stored at relative humidity above 65%, the powder absorbs moisture and caking occurs; desiccant-lined bulk bags are recommended. Granulation with 5% w/w povidone solution improved flow into veterinary granule sachets without changing the (R,S)-goitrin release profile. For powders intended for oral solution reconstitution, P2 grade is preferred because its smaller particle size reduces sedimentation during the dosing interval.
The API is not a fully soluble single molecule; water-dispersible polysaccharides and low-solubility constituents create an opalescent suspension and require agitation before dosing. At 10% w/v in hard water with total hardness above 200 mg/L as CaCO₃, calcium-bound polysaccharide flocs may settle within 30 min. Dispersion is stable for at least 6 h when vehicle pH is kept at 5.5–7.5, temperature is maintained below 35 °C, and conductivity does not exceed 1,000 µS/cm. For proportioner pump systems, pre-wetting with propylene glycol at 10–20% of final volume before adding water reduces nozzle blockage. Solutions prepared at 20 g/L should be stirred at 200–300 rpm for 15 min and passed through a 100 µm in-line strainer before entering dosing equipment.
P2 disperses faster than P1 but may generate foam during high-shear mixing. If a clear solution is required, the formulation must include a solubilizer such as cyclodextrin or a reduced polysaccharide grade; the standard veterinary grade alone will not yield a visually clear liquid. Water solubility is not a meaningful single-point specification because the product is a multi-component extract. Batch-to-batch dispersion behavior is therefore controlled by water-dispersible solids, particle size, and HPLC fingerprint similarity rather than by a single solubility value.
Compared with synthetic antiviral drug substances, Banlangen powder does not require a single-molecule dissolution specification. Its bioanalytical traceability relies on HPLC fingerprint similarity above 0.95 across five commercial lots, determined by congruence coefficient against a reference chromatogram at 254 nm. This is a fundamental difference from chemically synthesized ribavirin or amantadine APIs, where a single assay value and related-substances profile are sufficient for release. Compared with human-grade Banlangen extract powders, the veterinary grade differs mainly in microbiological control, residual solvent documentation, and veterinary-specific audit trail. Residual ethanol is not more than 0.5% w/w by headspace gas chromatography. Heavy metals are controlled against CPV 2020 limits for herbal extracts.
Operational boundaries include the following. Do not use in parenteral preparations without downstream bacterial endotoxin reduction. Do not process at pH below 3.0 or above 9.0. Avoid simultaneous incorporation of strong oxidizing agents because they degrade the sulfur-containing marker (R,S)-goitrin. Store at or below 25 °C and relative humidity below 60% in sealed HDPE drums with PE liners; retest interval is 24 months. Published data for clinical efficacy of Banlangen extract in specific veterinary target species is limited, and the manufacturer must rely on registered product dossiers for dose justification.
