| HS Code | 966428 |
| Product Name | Banqing Lianhuang Powder Veterinary Grade API |
| Api Type | Standardized animal-use Chinese medicine botanical extract |
| Source Material | Dried powders/extracts of Isatidis Radix (Banlangen), Isatidis Folium (Daqingye), Forsythiae Fructus (Lianqiao), and Scutellariae Radix (Huangqin) |
| Intended Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, and Solutions |
| Physical Appearance | Brownish-yellow to brown fine powder |
| Odor And Taste | Mild characteristic herbal odor with a bitter taste |
| Solubility | Partly soluble in water forming an opaque colloidal dispersion; soluble in dilute alcohol; practically insoluble in pure organic solvents |
| Ph Of 1 Percent Formulation | 5.5 to 7.0 |
As an accredited Banqing Lianhuang 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 | Packaging: Double polyethylene-lined fibre drums, net 25 kg per drum. Sealed, moisture-protected, labelled with product name and specifications. |
| Container Loading (20′ FCL) | One 20′ FCL shipment of Banqing Lianhuang Powder veterinary API, packed in sealed containers, palletized and secured for transport. |
| Shipping | Shipping for Banqing Lianhuang Powder (Veterinary Grade API) is conducted in sealed, moisture-proof containers to maintain purity and stability. All shipments include full safety documentation and compliance with veterinary pharmaceutical regulations. We offer secure, trackable global logistics via air, sea, or courier, with temperature-controlled options available for sensitive environments. |
| Storage | Store Banqing Lianhuang Powder Veterinary Grade API in its original, tightly sealed container in a cool, dry, well-ventilated area. Protect from direct sunlight, heat, moisture, and strong oxidizers. Maintain room temperature; avoid damp environments. After each use, reseal promptly. Follow labeled expiry date and all veterinary pharmaceutical storage guidelines. |
| Shelf Life | Shelf life: 24 months in unopened, well-sealed original containers stored in cool, dry, ventilated conditions away from light and moisture. |
Banqing Lianhuang Powder Veterinary Grade API is handled as a multi-component botanical solid with non-uniform particle geometry, hygroscopic fractions, and assayed marker constituents that shift under terminal heat exposure. Because downstream dosage forms include tablets, injections, capsules, powders, granules, premix, and solutions, the manufacturing route is selected only after evaluating tapped density, loss on drying, particle size distribution, angle of repose, and marker solubility in the target carrier. A release specification for non-sterile botanical APIs of this class typically includes loss on drying ≤5.0% w/w, total aerobic microbial count ≤10³ CFU/g, and Salmonella negative per 25 g. Screening through a 60-mesh sieve is used to remove coarse lignified material before charging. These parameters align with the monograph expectations of the China Veterinary Pharmacopoeia 2020 and the API GMP requirements of ICH Q7 sections 7.1 and 11.1.
Dry blending of an oral water-soluble powder for weaned piglets begins with a 1:5 geometric pre-mix of the botanical API and dextrose monohydrate in a 200 L V-blender operating at 60% working volume. The finished oral powder is formulated to deliver 5.0–10.0 g API per 100 g of powder, with anhydrous citric acid, sodium bicarbonate, and polyvinylpyrrolidone K30 as auxiliary dispersing and buffering agents. The pre-mix is screened through a 500 µm sieve before full batch addition. Final blending is conducted for 15 minutes at 25 rpm; blend uniformity is accepted only when ten sampling points yield assay values within 90.0–110.0% of label claim and relative standard deviation ≤5.0%. Powder temperature is kept below 35 °C and ambient relative humidity below 45% RH to prevent particle agglomeration and caking in the finished container. The process is controlled under 21 CFR 210/211 and ICH Q7 section 7.1; raw material identity is confirmed by FTIR or the pharmacopeial method before charging. The terminal product type is an oral water-soluble powder intended for administration via drinking water or top dressing.
In compound feed production, the API is incorporated into a carrier premix before it is metered into complete feed at the mixing plant. The primary process constraint is not the final addition ratio alone but the ability to achieve coefficient of variation below 5.0% RSD when the active substance is dosed at 0.05–1.0 kg per metric ton of complete feed. A first dilution step at 1:10 with spray-dried rice hulls or calcium carbonate is performed in a ribbon mixer with a working volume not exceeding 60% of total capacity. After 8 minutes of mixing, a second 1:10 dilution is prepared; only then is the premix introduced into a 2-ton paddle mixer for final dosing. This staging avoids the dead zones observed when raw API is added directly to complete feed lines. Compliance with EU 183/2005/EC feed hygiene and ISO 22000:2018 HACCP requires documented residue carry-over limits below 1.0% w/w for non-target feed batches. The terminal product is a medicated premix or complete feed powder.
Direct compression of Banqing Lianhuang Powder alone is not a robust route above a 25% w/w loading because its fibrous botanical particles exhibit high elastic recovery and capping at compression pressures above 150 MPa. Dry granulation by roller compaction at 30–50 bar hydraulic pressure, followed by screening through a 1.25 mm sieve, increases bulk density from 0.35 g/mL to 0.55 g/mL and yields granules with a Hausner ratio below 1.25. A representative tablet formula contains 30.0% w/w API, 48.0% w/w microcrystalline cellulose PH102, 15.0% w/w lactose monohydrate, 5.0% w/w croscarmellose sodium, and 2.0% w/w magnesium stearate. Tableting on a rotary press with 12 kN compression force and 60 rpm turret speed produces 500 mg tablets with hardness 8–10 kp. Friability is controlled to ≤0.8% per USP <1216>. Compliance for veterinary tablets follows 21 CFR 210/211 and ICH Q7 because the product is intended for oral administration in swine and cattle. The terminal dosage form is a divisible veterinary tablet.
When the active botanical powder is filled into hard gelatin capsules at 20.0–30.0% w/w loading without granulation, low bulk density and particle cohesion create fill weight variability and powder bed starvation in dosing-disk capsule machines. Pre-processing by dry granulation with 5.0% w/w pregelatinized starch and 1.0% w/w talc results in a granule with angle of repose 32–35°, Carr index ≤20%, and bulk density 0.48–0.52 g/mL. The API is first de-aggregated through a conical mill fitted with a 0.25 mm screen, then blended in a V-blender for 15 minutes at 50% capacity. Capsule filling on an intermittent machine with 0.90 mm dosing disk and 10 mm pin height achieves weight variation ≤3.0% RSD for 250 mg fill weight. In-process verification includes weight checks every 15 minutes and moisture limit ≤5.0% w/w. This route is appropriate for companion animal veterinary capsules. Compliance is based on 21 CFR 211.84 raw material identity testing and 21 CFR 211.110 in-process sampling. Terminal product type is oral hard gelatin capsule.
| Dosage form | API loading | Key granulation route | Critical in-process limit | Terminal product |
|---|---|---|---|---|
| Oral water-soluble powder | 5.0–10.0 g/100 g | Low-shear dry blending | Blend RSD ≤ 5.0% | Drinking-water powder |
| Feed premix | 0.05–1.0 kg/t | Staged geometric dilution | CV < 5.0% RSD | Medicated premix |
| Veterinary tablet | 30.0% w/w | Roller compaction plus rotary compression | Hardness 8–10 kp | Divisible tablet |
| Hard gelatin capsule | 20.0–30.0% w/w | Dry granulation plus dosing-disk filling | Fill variation ≤ 3.0% RSD | Oral capsule |
| Effervescent granule | 10.0–20.0% w/w | Fluid-bed spray granulation | Moisture 1.5–2.5% w/w | Dispersible granule |
Preparation of an injectable solution from Banqing Lianhuang Powder requires sequential clarification before terminal sterile filtration because the raw powder contains lignified botanical fragments and water-insoluble constituents. In an injectable formulation, 1.0%–5.0% w/v of the botanical API is dispersed in Water for Injection containing 10–20% v/v propylene glycol and 0.1% w/v sodium metabisulfite as antioxidant. The suspension is stirred at 60 °C for 60 minutes, cooled to 25 °C, then pre-filtered through a 5.0 µm polypropylene depth filter and a 0.45 µm PVDF membrane; sterile filtration through a 0.22 µm PVDF cartridge follows. Processing limits include maximum filter differential pressure of 1.5 bar and total normalized throughput of not more than 800 L/m² before cartridge replacement due to membrane fouling. Autoclaving at 121 °C for 15 minutes is generally avoided because published data for marker stability under terminal steam sterilization of this specific botanical mixture is limited, and aseptic filtration is preferred. Compliance follows EU GMP Annex 1 aseptic processing requirements and VICH GL18 for residual solvents. The terminal dosage form is a sterile veterinary injection.
For concentrated drinking-water solutions and oral drench liquids, the powder is dispersed rather than fully dissolved because not all botanical markers remain in molecular solution at neutral pH. In solution manufacturing, 2.0–8.0 g of API per 100 mL is mixed with 0.5% w/w sodium citrate dihydrate, 0.2% w/w potassium sorbate, and 0.5% w/w citric acid in purified water at 40 °C. The mixture is high-shear mixed with a rotor-stator homogenizer operating at 3000 rpm for 15 minutes to reduce particle aggregates below 10 µm. The liquid is then passed through a 50 µm in-line strainer and filled into amber polyethylene terephthalate bottles. Terminal product is an oral solution or concentrated drinking-water solution for pigs and poultry. Process controls align with 21 CFR 210/211 and EU Regulation 2019/6; in-process pH is maintained at 4.0–4.5 to retard microbial proliferation and reduce precipitation of acid-sensitive fractions.
Fluid-bed spray granulation is used when the final granule must disperse rapidly in cold tap water without leaving insoluble residues. A powdered API addition ratio of 10.0–20.0% w/w is first blended with crystalline citric acid, sodium bicarbonate, sorbitol, and 5.0% w/w sodium starch glycolate. The blend is fluidized at 45–50 °C using a Wurster column with an inlet humidity below 30% RH to prevent premature acid-base reaction during processing. An aqueous binder of 2.0% w/w polyvinylpyrrolidone K30 and 0.5% w/w polysorbate 80 is sprayed through a 1.2 mm nozzle at 2.5 bar until granules reach D50 250–400 µm. After drying to moisture 1.5%–2.5% w/w, the granules are sealed in foil sachets without exposure to ambient humidity above 55% RH. Terminal dosage form is an effervescent or rapidly dispersible veterinary granule for administration via drinking water or oral syringe. Monographs from the China Veterinary Pharmacopoeia 2020 and loading validation under ICH Q7 section 12 provide the applicable standards.
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Banqing Lianhuang Powder Veterinary Grade API is a crude multi-botanical powder manufactured from four pharmacopoeially recognized plant materials: Isatidis Radix, Indigo Naturalis, Forsythiae Fructus, and Phellodendri Chinensis Cortex. The product is dry-milled after low-temperature drying and is supplied as an unextracted active pharmaceutical ingredient for subsequent manufacture of veterinary tablets, capsules, oral powders, granules, premixes, and liquid oral preparations. The model designation BQLH-VAPI denotes the standard 80-mesh grade with not less than 95% passage through a 180 µm sieve; BQLH-VAPI/100 and BQLH-VAPI/200 identify finer milling grades intended for capsule blends and suspension vehicles where sedimentation rate must be reduced. Unlike purified dry extracts or isolated marker compounds, the veterinary-grade powder retains the native plant matrix, including cellulosic tissues, mineral ash, and bound polyphenols. This retention alters downstream processing in a measurable way: the material is only partially water-soluble, exhibits a bulk density commonly in the range of 0.45–0.70 g/cm³ after tapping, and requires formulation-specific particle-size reduction before uniform tablet compression. The API is not a sterile or apyrogenic material and is not intended for direct intravenous or intramuscular injection without further extraction, purification, and terminal sterilization. The product is produced under an active pharmaceutical ingredient quality system aligned with ICH Q7; batch release depends on the supplier’s certificate of analysis because no fully harmonized international monograph currently defines identity and assay limits for this specific multi-herb combination.
| Parameter | Method / reference | Typical control limit for BQLH-VAPI standard grade | Relevance for downstream processing |
|---|---|---|---|
| Appearance | Visual inspection | Brownish-yellow to brownish-green powder | Indicates drying and milling consistency |
| Particle size | ISO 2591-1:2008 | ≥95% through 180 µm | Controls blend uniformity and powder dosing |
| Loss on drying | USP 731 | NMT 5.0% | Prevents mold growth and tablet sticking |
| Total ash | USP 561 | NMT 15.0% | Limits abrasive mineral load and punch wear |
| Acid-insoluble ash | USP 561 | NMT 5.0% | Detects soil contamination |
| Lead / cadmium / arsenic / mercury | USP 233, ICP-MS | Pb NMT 10 mg/kg; Cd NMT 1 mg/kg; As NMT 2 mg/kg; Hg NMT 0.1 mg/kg | Elemental impurity control |
| Total aerobic microbial count | ChP 1105 | NMT 104 CFU/g | Non-sterile dosage form control |
| Molds and yeasts | ChP 1106 | NMT 102 CFU/g | Fungal contamination control |
| Escherichia coli / Salmonella | ChP 1105 / ChP 1106 | Absent in 1 g / absent in 25 g | Pathogen exclusion |
| Bulk / tapped density | USP 616 | 0.45–0.70 g/cm³ | Hopper design, capsule fill, powder flow |
These values are not universally harmonized; they represent common release criteria for crude botanical powders used in veterinary oral dosage forms and must be superseded by the approved specification in the marketing authorization or site master file. Each parameter is measured by a defined method so that batch-to-batch variability can be trended. Loss on drying by USP 731 at 105 °C to constant mass is critical because residual moisture above 5.0% can accelerate mold growth and alter tablet hardness. Total ash and acid-insoluble ash act as markers for mineral contamination from harvest soil; ash levels above the upper limit can interfere with dry blending and increase abrasive wear on rotary tablet punches. Heavy metal screening by ICP-MS according to USP 233 is applied because the product is obtained from field-grown plant material that may accumulate lead, cadmium, arsenic, and mercury. Microbial limits follow ChP 1105 and ChP 1106; because the powder is not sterile, the total aerobic microbial count is usually controlled at not more than 104 CFU/g, with absence of Escherichia coli in 1 g and absence of Salmonella in 25 g. Particle-size distribution is determined by air-jet sieving with ISO 2591-1:2008; the standard grade passes ≥95% through 180 µm, while the fine grade is specified against a 150 µm or 75 µm sieve depending on dosage form. Published data for batch-to-batch variance in this specific formulation is limited; manufacturers usually set in-house control limits based on at least 20 production batches.
Compared with purified Banqing Lianhuang dry extract or isolated marker compounds such as berberine hydrochloride, the crude powder carries a substantially larger mineral and fiber burden. This is a material difference for formulation: a dry extract standardized to a marker may be readily dissolved or dispersed into a clear or translucent liquid, whereas the crude API leaves insoluble plant residue and requires thickening or suspension aids in oral liquids. In tablet manufacture, the crude powder’s high fiber content reduces compactability unless a binder such as povidone and a disintegrant such as croscarmellose sodium are added in the wet-granulation step. Compared with synthetic antibiotic APIs, this product does not have a single defined assay of one active molecule; it contains multiple components, including indigo alkaloids from Indigo Naturalis, berberine-type alkaloids from Phellodendri Cortex, and phenylethanoid glycosides from Forsythiae Fructus. Therefore, the active ingredient cannot be described by a single purity value such as 99.0%. Instead, quality is expressed through marker content, botanical identity, and absence of contaminants. The product also differs from finished veterinary premixes: no carrier, diluent, preservative, or flavoring is included. A premix manufacturer must add a suitable carrier such as lactose, corn starch, or calcium carbonate to improve flow and reduce dusting. Because this is a veterinary-grade API, any use in food-producing animals must comply with withdrawal periods and regional maximum residue limit frameworks when applicable. Published clinical outcome data for this specific formulation is limited, and efficacy in a given target species should be demonstrated through controlled studies under the relevant veterinary medicinal product regulations.
The standard grade at ≥95% through 180 µm is acceptable for oral powders and premixes but may segregate in high-speed tablet compression if the distribution is bimodal. Fine grades passing 150 µm or 75 µm improve blend homogeneity in low-dose tablet formulations but increase surface area, which can raise moisture sorption at relative humidity above 60%. Flow characterization should include poured and tapped density per USP 616. From these values, the Carr index and Hausner ratio are derived. A Hausner ratio above 1.25 indicates poor flow and requires glidant addition, typically colloidal silicon dioxide at 0.5–1.0 wt%, or dry granulation. For capsule filling, the target is usually a tapped density above 0.60 g/cm³ and a repose angle below 40° after glidant addition; otherwise capsule fill weight variability increases beyond 5% relative standard deviation on automatic dosators. For premix applications, the API powder is blended with carriers in a ribbon blender or V-blender; the blend is assessed for homogeneity by sampling at least 10 points and analyzing marker content by high-performance liquid chromatography. The acceptance criterion for blend uniformity is often 90.0–110.0% of label claim with relative standard deviation not more than 5.0%. Because this material is hygroscopic in high-humidity environments, pre-drying at 45 °C to 50 °C in a fluid-bed dryer is recommended before milling or blending when warehouse relative humidity exceeds 60%. Residual moisture after drying should be retested by USP 731 before compression; moisture above 5.0% can cause picking and sticking on rotary tablet presses.
Wet granulation of BQLH-VAPI is typically performed in a high-shear granulator with impeller speed 200–400 rpm and chopper speed 1500–3000 rpm, using purified water or binder solution. The endpoint is determined by torque and visual consistency; overwetting produces hard granules that require milling and reduces tablet disintegration. A binder such as povidone at 2–5 wt% of dry granule mass is used because the plant fiber has poor native binding. Disintegrant at 3–5 wt% is added in the extra-granular phase to achieve disintegration below 15 min in 37 °C water per USP 701. Lubricant magnesium stearate at 0.5–1.0 wt% is added after granulation because the high surface area of the powdered herb can bind lubricant and slow dissolution. Compression force on a rotary press is adjusted to 8–15 kN depending on tablet diameter; hardness of 50–100 N and friability below 1.0% per USP 1216 are typical acceptance ranges. During process development, tabletability, compressibility, and compactibility are profiled on an instrumented tablet press to avoid capping caused by elastic recovery of lignified plant fibers.
The crude powder is not suitable for direct injection. It is a non-sterile particulate botanical material with endotoxin load that will vary with harvest and storage conditions. A manufacturer requiring an injectable dosage form must first prepare a decoction or hydroalcoholic extract from the API, then clarify by centrifugation, depth filtration, and membrane filtration at 0.45 µm followed by 0.22 µm. Terminal sterilization at 121 °C for 15 min may be applied only after formulation stability and pH compatibility have been confirmed; autoclaving can precipitate tannins and polysaccharides, producing visible particulate matter that fails USP 788. The finished injectable solution must meet the bacterial endotoxin limit specified in the marketing authorization, commonly below 0.5 EU/mL for intravenous products and higher for intramuscular products depending on dose volume. Bacterial endotoxin should be tested by USP 85. If the marketed product is a solution for oral administration, the raw API can be dispersed in a suspending vehicle with sodium carboxymethylcellulose or xanthan gum; sedimentation volume and redispersibility should be assessed at 25 °C after 24 h. Published data for this specific configuration is limited, so development batches should include a minimum of three production-scale lots to establish extraction efficiency and filtration throughput.
For capsule products, the standard API is often passed through a 0.5 mm or 0.2 mm screen and blended with lactose monohydrate and sodium starch glycolate. Capsules are filled on a dosator or tamping-pin machine to a target fill weight; fill weight variation is controlled at not more than 4% relative standard deviation for 300 mg or larger capsules. Because the crude powder has variable bulk density, fill weight must be calculated from tapped density rather than assumed from volume. For oral solutions and suspensions, the powder is added to a co-solvent system of purified water and glycerol or propylene glycol. The pH is adjusted with citrate buffer to 4.5–6.5 to reduce hydrolysis of phenolic glycosides. Preservatives such as sodium benzoate at 0.1–0.2% may be required for multi-dose bottles. The final liquid should be evaluated for zeta potential or sedimentation height after 24 h to ensure uniform dosing on shaking.
Premix compatibility with acidifiers, mineral premixes, and choline chloride should be evaluated before large-scale blending because the botanical matrix contains polyphenols, alkaloids, and organic acids. Acidic carriers at pH below 4.0 can ionize basic alkaloids and change particle-surface charge, which may reduce blend homogeneity or promote caking. Trace metal ions in mineral premixes—particularly iron, copper, and manganese—can catalyze oxidation of polyphenols and darken the blend during storage. Where the API is blended with choline chloride at high inclusion, the hygroscopicity of choline chloride accelerates moisture uptake; moisture content should be monitored at 40 °C/75% RH for stress testing. The powder should not be autoclaved in dry form because steam penetration is uneven in dense plant fiber and caking can occur. The API is not compatible with strong oxidizing agents; avoid direct blending with sodium percarbonate or calcium hypochlorite unless a protective carrier pre-blend is used.
Identity confirmation uses high-performance thin-layer chromatography and HPLC fingerprinting. The method should resolve marker bands for indigo, berberine, and forsythoside A. System suitability is evaluated by resolution between berberine and palmatine, with resolution not less than 1.5. Quantification of berberine hydrochloride by HPLC with UV detection at 345 nm may use a C18 column and acetonitrile–phosphate buffer mobile phase at pH 3.0. However, published data for this specific product is limited; laboratories must validate the method according to ICH Q2(R1).
Stability studies for the veterinary API should follow VICH GL3 where applicable. Long-term storage for climatic zone II is usually 25 °C/60% RH; accelerated testing is 40 °C/75% RH. Because the powder is hygroscopic, the container-closure system must be selected for moisture protection. Aluminum-laminated foil bags with desiccant are commonly used for bulk supply; a 25 kg net weight in double poly-lined fiber drums is typical. Under accelerated conditions, total aerobic microbial count, moisture, and marker degradation should be tested at 0, 3, and 6 months. Published long-term data for this specific product is limited, so a retest period of 24 months cannot be assumed without manufacturer data. The site master file should document moisture sorption isotherms at 25 °C, 30 °C, and 40 °C to support packaging choices. Storage below 25 °C in a dry area is recommended; exposure to direct sunlight and temperature cycling above 40 °C should be avoided.
