| HS Code | 873939 |
| Product Name | Baitouweng Likang Powder Veterinary Grade API |
| Dosage Forms | Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Api Name | Baitouweng Likang Powder (Veterinary Grade Active Pharmaceutical Ingredient) |
| Active Constituents | Pulsatilla saponins and related bioactive compounds from Baitouweng (Pulsatilla chinensis) |
| Intended Species | Livestock and poultry (e.g., pigs, cattle, sheep, chickens, ducks) |
| Pharmacological Action | Antibacterial, anti-inflammatory, antipyretic, and antidysenteric effects |
| Indications | Treatment of bacterial enteritis, dysentery, and gastrointestinal infections in veterinary medicine |
| Administration Routes | Oral (via water, feed, or direct dosing) and parenteral (injectable formulations) |
| Storage Conditions | Store in a cool, dry, well-ventilated area away from direct sunlight and moisture |
| Shelf Life | Typically 24 months when sealed and stored under recommended conditions |
| Quality Standard | Veterinary Grade API conforming to pharmacopoeial purity and safety specifications |
As an accredited Baitouweng Likang 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 | Packaged in 25 kg fiber drums with double polyethylene liners, sealed moisture-proof, labeled for veterinary use. |
| Container Loading (20′ FCL) | 20′ FCL container loading: Baitouweng Likang Powder veterinary API sealed in drums/cartons, palletized, secured to ensure safe, stable transport. |
| Shipping | Our veterinary-grade Baitouweng Likang Powder is shipped in sealed, moisture-proof drums with tamper-evident packaging. We ensure cold-chain or ambient transport as required, with full documentation, COA, and customs compliance. Globally available via express or air/sea freight, with robust protective cushioning to guarantee product integrity during transit. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature (below 25°C). Keep the container tightly sealed and protected from light, moisture, and direct sunlight. Avoid contact with incompatible substances. Ensure proper labeling and segregation in accordance with veterinary API handling guidelines. |
| Shelf Life | Shelf life for this veterinary API is 24 months in original sealed container below 25°C, protected from moisture and light. |
In nursery pig production, post-weaning enteritis control through medicated feed requires Baitouweng Likang Powder Veterinary Grade API to be introduced through a dedicated micro-ingredient line. The starting fraction is screened through a 450 µm (40 mesh) circular vibratory sieve and temporarily stored in a stainless-steel receiving bin with a relative humidity alarm set at 45%. The addition ratio for this route is calculated from the Chinese Veterinary Pharmacopoeia (CVP 2020, Part 2) reference dosage for Baitouweng San in swine of 30–45 g crude powder per animal per day. At a standardized extract ratio of 10:1, the equivalent API intake is 3.0–4.5 g per animal per day; with a nursery dry-matter intake of 1.0 kg per animal per day, the complete feed inclusion rate becomes 3.0–4.5 kg/tonne. For a 0.5% medicated premix dilution step, the premix loading is 600–900 kg/tonne; for a 1.0% premix it is 300–450 kg/tonne. The conversion matrix across extract ratios is given below.
| Extract ratio | CVP crude reference (g/pig/day) | API intake (g/pig/day) | Complete feed inclusion (kg/tonne) | 0.5% premix loading (kg/tonne) |
|---|---|---|---|---|
| 5:1 | 30–45 | 6.0–9.0 | 6.0–9.0 | 1,200–1,800 |
| 10:1 | 30–45 | 3.0–4.5 | 3.0–4.5 | 600–900 |
| 20:1 | 30–45 | 1.5–2.25 | 1.5–2.25 | 300–450 |
The production process uses a 1,500 L horizontal ribbon mixer with a 22 kW drive and agitator speed of 20–25 rpm. The botanical extract is pre-blended with colloidal silicon dioxide at 1.0–2.0% w/w of the API mass before introduction to the mixer to reduce electrostatic adhesion to the carrier; the carrier itself is ground corncob or rice hull with a particle-size window of 100–800 µm, moisture content below 10%, and aflatoxin B1 below 10 µg/kg. Geometric dilution sequencing is observed: the API-silica pre-blend is first combined with an equal mass of carrier and mixed for 6 min, then the remaining carrier is added and the batch is mixed for a further 8–10 min. Homogeneity is verified by sampling 10 points across the mixer trough and assaying anemoside B4 by HPLC-UV; the acceptance limit is a coefficient of variation below 7%. Cross-contamination control in the feed mill requires a flush sequence with 20 kg of ground limestone after each batch; the flush material is quarantined and cannot be reworked into subsequent batches. Compliance is anchored to Regulation (EC) No 183/2005 for feed hygiene requirements and Regulation (EU) 2019/4 where the product is registered as a medicated feed ingredient in the relevant jurisdiction; in China, the CVP 2020 Part 2 monograph for Baitouweng San provides identity and assay limits, and production must follow veterinary drug Good Manufacturing Practice under the Ministry of Agriculture and Rural Affairs. The terminal product type is a free-flowing 0.5% or 1.0% medicated premix packed in 25 kg multi-wall paper bags with an inner polyethylene liner, heat-sealed, and palletized for feed-mill receiving.
The limiting parameter in waterborne administration of Baitouweng Likang Powder Veterinary Grade API is not the chemical stability of the anemoside B4 marker but the physical rehydration and dispersion behavior in farm utility water. The particulate extract after spray drying exhibits a bulk density of 0.30–0.40 g/mL and tends to form hydrated agglomerates when introduced into water with total hardness above 250 mg/L CaCO₃ or pH above 7.8. For broiler applications, the CVP 2020 dosage for Baitouweng San in poultry of 2–3 g crude powder per bird per day is converted through a 10:1 extract ratio to 0.2–0.3 g API per bird per day. At a modelled daily water intake of 200 mL, the target concentration is 1.0–1.5 g/L. The production process therefore blends the spray-dried extract with anhydrous glucose and citric acid monohydrate in a V-blender with intensifier bar, operating at 10–15 rpm for 20–30 min, to produce a water-soluble powder with a reconstitution pH of 4.5–5.5. The citric acid fraction is held at 2–5% w/w, and the glucose fraction is adjusted by difference. The blended powder is sieved through 600 µm and filled into 100 g aluminium-laminated sachets under a controlled environment of <40% relative humidity. On the farm, the powder is reconstituted to a 100 g/L stock solution and injected into the drinking line by a diaphragm metering pump with a flow range of 2–20 L/h, calibrated to an injection ratio of 1.0–1.5% v/v. The injection point is located upstream of the drinker ring after the water meter, and a minimum contact time of 10 s is maintained before the first drinker. Field-relevant failure modes include meter pump diaphragm failure from undissolved botanical particulates, precipitation of calcium-carbonate-bound saponins in hard water, and microbial biofilm growth in stock solution tanks after 4 h of stagnation; stock tanks should be cleaned with citric acid rinse and refilled within 2 h. Compliance for the drinking-water route is guided by the EU Regulation 2019/6 framework for veterinary medicinal products and by the general CVP 2020 requirements for water-soluble powders; where no public monograph defines a wet-sieve particle limit for this specific API, development specifications commonly apply a 180 µm wet-sieve criterion, but published data for this specific configuration is limited. The terminal product type is a 100 g or 500 g water-soluble powder in moisture-barrier sachets, dispensed through proportioner devices into drinking lines.
Sterile production of an injectable presentation from Baitouweng Likang Powder Veterinary Grade API subjects the botanical extract to a sequence of depyrogenation, clarification, and aseptic filtration in which the limiting unit operation is membrane fouling by high-molecular-weight polysaccharide and condensed tannin fractions. The starting solution is prepared in Water for Injection at an API concentration of 0.05–0.10 g/mL, corresponding to 0.5–1.0 g/mL crude equivalence at a 10:1 extract ratio, with benzyl alcohol at 1.5% v/v as preservative for multi-dose vials and sodium citrate buffer to pH 5.5–6.5. The solution is cooled to 2–8°C for 12–18 h to precipitate cold-insoluble polysaccharides and is then clarified through a 0.45 µm polyethersulfone membrane. Sterile filtration uses a 0.22 µm double-layer PVDF capsule filter with an effective filtration area of 0.5–1.0 m² per 100 L; flux decline of more than 30% within 15 min indicates a need for additional pre-filtration or enzymatic clarification, and the filter capsule is not reused. Terminal sterilization by saturated steam at 121°C for 15 min is generally avoided for anemoside B4-bearing formulations because the saponin marker degrades under prolonged high-temperature exposure; instead, aseptic filling is used under Grade A laminar airflow within EU GMP Annex 1 and ISO 14644 Class 5 conditions. The filling line uses a ceramic rotary piston pump with a fill-volume tolerance of ±1.5% and nitrogen overlay in the filling tank to reduce oxidative darkening. Compliance for sterility and endotoxin is demonstrated by USP <71>, USP <85>, and USP <788>; particulate limits follow EU GMP Annex 1 for injectables, and container quality is tested under Ph. Eur. 3.2.1 for Type II glass. The terminal product type is a 20 mL or 50 mL amber Type II glass vial with bromobutyl rubber stoppers and aluminium overseals, labelled for parenteral use under veterinary prescription for neonatal calf enteritis adjunct therapy.
When the API is formulated as a tablet for small ruminant oral dosing, the principal process constraint is powder flow before compression. The spray-dried botanical extract typically exhibits an angle of repose above 42° and a compressibility index above 25%, which prevents direct compression at press speeds above 30 rpm. The formulation is therefore processed by wet granulation, with the API adjusted to elementary composition and blended with microcrystalline cellulose at 30–50% w/w, lactose monohydrate at 20–40% w/w, croscarmellose sodium at 2–5% w/w as disintegrant, colloidal silicon dioxide at 0.5–1.5% w/w, and magnesium stearate at 0.5–1.0% w/w added after granulation. The wet mass is prepared in a planetary mixer at 60–80 rpm using purified water as the granulating liquid, passed through a 1.5 mm screen, tray-dried at 40–45°C to final moisture below 3%, and milled through an 800 µm oscillating granulator. Tableting is performed on a 16-station rotary press with compression force set between 8–14 kN, target hardness of 40–80 N, and friability below 1.0% after 100 revolutions in a Ph. Eur. 2.9.7 tester. Tablet mass uniformity follows Ph. Eur. 2.9.5, and disintegration follows Ph. Eur. 2.9.1 with a 15 min limit in water at 37±2°C. The terminal product type is a 500 mg or 1,000 mg uncoated tablet packed in 100-count HDPE bottles with desiccant.
Dosator-type capsule filling of Baitouweng Likang Powder Veterinary Grade API requires granulation before encapsulation because the spray-dried extract contains an excess of fines below 75 µm and exhibits powder bridging at filling speeds above 30 cycles/min. The granulation is performed in a top-spray fluid bed with a 5% w/v povidone K30 binder solution, inlet air temperature 55–70°C, product temperature 30–38°C, and spray rate 80–120 g/min for a 25 kg batch. After drying, the granule is sieved through 850 µm and retained on 250 µm; the fine fraction below 250 µm is reintroduced into the next binder batch, not discarded. The final blend is adjusted to a bulk density of 0.55–0.65 g/mL and tapped density of 0.80–1.20 g/mL, measured by Ph. Eur. 2.9.34. Filling is performed on a dosator machine with pin height 18–22 mm and station speed 25–35 cycles/min; fill weight is verified every 15 min with a 0.1 mg balance, and acceptable variation is ±5% for capsules below 300 mg fill weight. The capsule shell for canine products is size 0 at 250–500 mg fill weight; for feline products, shell size 3 is used at 150–250 mg. Uniformity of dosage units is tested under Ph. Eur. 2.9.40, and mass uniformity under Ph. Eur. 2.9.5. The terminal product type is a hard gelatin or hydroxypropyl methylcellulose capsule packed in PVC/PVDC blister with 10 capsules per strip.
Oral granule production for feed top-dressing in sheep and lambs uses wet granulation rather than dry blending because the target finished granule size of 500–1,000 µm is required to limit dusting and to maintain segregation resistance when the granule is spread over a total mixed ration. The API is mixed with sucrose powder at 10–20% w/w as water-soluble carrier, microcrystalline cellulose at 20–30% w/w as filler, and povidone K30 at 3–5% w/w as binder; the dry blend is granulated with purified water in a high-shear mixer at impeller speed 150–200 rpm. The wet mass is extruded through a 2.0 mm screen, spheronized at 400–600 rpm for 5–8 min, and dried in a tray dryer at 40–45°C to moisture below 3%. The addition ratio for sheep is derived from CVP 2020 Baitouweng San dosage of 30–45 g crude per animal per day; for a 10:1 extract ratio the API dose is 3.0–4.5 g per animal per day, which is provided by 10–15 g of a granule containing 30% w/w API. Compliance follows the granule general chapter of CVP 2020 and, for export, the relevant requirements of the overseas veterinary drug registration dossier. The terminal product type is a 500 g polypropylene jar with a 10 g dosing spoon and induction-sealed liner.
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Baitouweng Likang Powder Veterinary Grade API is a processed botanical active pharmaceutical ingredient derived from Pulsatilla chinensis (Bunge) Regel and supplied as a free-flowing powder for incorporation into tablets, injections, capsules, powders, granules, premixes, and solutions. The material is not a finished dosage form and is not intended for direct administration without formulation, dilution, or extraction according to the target route. Supplier documentation identifies the article by pharmacopoeial name and lot code rather than a universal model number; a representative material code used in procurement specifications is BLK-P-2405, but the valid vendor article number must be read from the certificate of analysis for each delivery. The defining characteristics of this grade are standardized marker content, controlled particle-size distribution, reduced fibrous residue, and application-specific heavy metal and microbial limits.
Pharmacopoeial positioning of this material corresponds to the traditional veterinary preparation Pulsatilla Powder, also described in some formularies as Baitouweng San. It differs from simple milled root because the powder is air-classified and specified by marker content rather than by raw plant macroscopic identity alone. The analytical marker is typically anemoside B4, a triterpenoid saponin, expressed by high-performance liquid chromatography on the dried basis. Actual lot concentrations are product-specific; procurement specifications commonly require not less than 4.0% anemoside B4. A separate semi-purified extract may contain 10.0% or more of the same marker, while unclassified crude root powders often fall between 0.5% and 1.5%. The Likang powder therefore occupies an intermediate position between crude botanical powder and concentrated extract, retaining native non-marker constituents while offering greater analytical consistency than crude material.
The powder is produced under veterinary GMP controls with batch records covering incoming botanical identity, drying, milling, classification, blending, metal detection, and final sampling. Because no single model number is recognized across all pharmacopoeias, finished-dose manufacturers should specify the following on the purchase order: botanical source, marker content, sieve cut or laser-diffraction D90, loss on drying, total ash, residual solvents, microbial limits, and packaging. Without these parameters, lot-to-lot variation can affect tablet hardness and injection filtration throughput.
Because the material is intended for seven different dosage-form routes, the optimal particle-size distribution is not uniform. Tablets and capsules usually require a fine, free-flowing powder; premixes and granules may tolerate coarser particles but are more sensitive to blend segregation; injectables and solutions require extraction or filtration before use and therefore are less dependent on dry-flow properties than on extractive consistency and low endotoxin load.
The primary technical differences are observed in four areas: marker standardization, particle-size control, microbial burden, and excipient compatibility. Crude pulsatilla root powder exhibits macroscopic identity and may pass a pharmacopoeial thin-layer chromatography identification test, but its marker concentration and particle-size distribution can vary widely with growing region, harvest year, and drying method. The Likang powder grade is blended to a declared marker band and classified to a defined D90, which reduces the need for reformulation at the finished-dose stage. Retention of native root constituents distinguishes it from purified extract; this can be relevant where the non-saponin fraction contributes to clinical effect or where a highly purified extract creates solubility, reconstitution, or cost limitations.
| Parameter | Baitouweng Likang Powder-grade API | Crude root powder | Semi-purified extract |
|---|---|---|---|
| Marker content as anemoside B4, dried basis | ≥ 4.0% | 0.5–1.5% typical | ≥ 10.0% |
| Laser-diffraction D90 | ≤ 150 µm | often > 250 µm | ≤ 100 µm typical |
| Loss on drying | ≤ 5.0% | 8–12% typical | ≤ 3.0% |
| Total ash | ≤ 7.0% | often > 10% | ≤ 5.0% |
| Total aerobic microbial count | ≤ 10³ CFU/g | variable, frequently untreated | ≤ 10³ CFU/g |
| Endotoxin limit for parenteral screening | vendor-specific; < 0.25 EU/mg required for injectable use | not normally controlled | vendor-specific |
These values are procurement specifications, not batch release certificates. Actual results must be verified against the vendor certificate of analysis for each lot.
Finished-dose manufacturers typically apply the following test designations: loss on drying by USP <731> or equivalent oven method at 105°C; total ash by USP <561>; elemental impurities by USP <232> and USP <233> or ICH Q3D; residual solvents by USP <467>; microbial enumeration by USP <2021> and specified organisms by USP <2022>; and bacterial endotoxins by USP <85> when the route is parenteral. Particle-size distribution is determined by laser diffraction according to ISO 13320-1:2020 or by sieve analysis per USP <786>. Bulk and tapped density are measured by USP <616>, and powder flow is assessed by USP <1174>.
The product specification should also include macroscopic and microscopic identity, thin-layer chromatography profile, and heavy metal speciation. For veterinary APIs intended for multi-species feed or premix use, control strategies should address carryover and cross-contamination under EU Regulation 2019/4 on medicated feed, and current GMP for veterinary products as described in EU GMP Annex 2 or equivalent national guidelines. Supplier documentation should state whether the material is irradiated or treated with ethylene oxide; these are not normally accepted for a botanical veterinary API without registration-specific approval.
Density parameters influence capsule filling and tablet compression. A bulk density below 0.45 g/mL and tapped density above 0.70 g/mL can increase fill weight variability in low-speed dosator capsule machines. These values are guidance thresholds, not pharmacopoeial acceptance criteria; botanical lots should be qualified on the specific filling line.
For tablet manufacture, the API is blended with a directly compressible filler such as microcrystalline cellulose and a disintegrant such as crospovidone. The product is not typically compressed as a pure powder; a dry granulation step may be used when the D90 exceeds 180 µm or when bulk density is below 0.45 g/mL. Magnesium stearate levels above 1.0% w/w can prolong disintegration and reduce tablet hardness, especially if the botanical powder contains free fatty acids or residual moisture above 5.0%. Precompression force, turret speed, and hopper vibration are adjusted for flow variability. Finished tablets manufactured from the API should be checked for content uniformity by USP <905>, disintegration by USP <701>, and dissolution where applicable by USP <711>. If the powder is intended for capsules, target D90 below 150 µm and loss on drying below 5.0% reduce powder bridging and tamping pin variability.
Granules and premixes require carrier selection to preserve homogeneity. A premix carrier such as calcium carbonate or ground corn cob may be used at a dilution ratio determined by the dose. In low-shear tumble blenders, segregation risk increases when the geometric mean particle size of the botanical powder and carrier differ by more than a factor of 3. A common remedial strategy is to mill the botanical API through a 0.5 mm or smaller screen before addition to the carrier. Uniformity of dosing units for medicated premixes is verified according to USP <905> or equivalent national monographs.
Use of Baitouweng Likang Powder in injectable products is not a direct reconstitution process. The API is typically extracted with water or an aqueous alcohol mixture, filtered through a sequence of decreasing pore sizes down to 0.22 µm or 0.45 µm, and then filled. The extraction step carries most of the saponin fraction into solution, while fibrous plant residue and high-molecular-weight polysaccharide material remain partly insoluble. Filtration throughput is sensitive to total ash and insoluble particle load; a crude root powder with total ash above 10% will reduce membrane throughput more than a classified material with total ash below 7.0%. If the solution is intended for parenteral administration, the finished product must meet bacterial endotoxin limits appropriate to the species and route. For the raw botanical powder, a vendor release limit of < 0.25 EU/mg is a typical screen; however, this limit alone does not guarantee that a finished injectable will pass the finished-product test because process water, containers, and excipients contribute to the total endotoxin load.
Solution formulations also require attention to pH and solvent composition. Saponins such as anemoside B4 are sensitive to strongly acidic hydrolysis; prolonged exposure below pH 3.0 can degrade the marker and create aglycone precipitates. Solutions should be buffered only after compatibility testing because phosphate buffers can interact with calcium and magnesium present in the botanical matrix. Co-solvents such as propylene glycol may be used for poorly water-soluble fractions, but solvent concentration should not exceed the tolerance established for the target species. Published data for this specific powder in concentrated injection vehicles is limited; pilot-scale extraction trials are required.
Wet granulation using water or aqueous binder solutions exposes the marker saponin to hydrolysis. The degradation rate depends on granulation temperature, residence time, and binder pH. Aqueous granulation at inlet air temperatures above 60°C during fluid-bed drying should be justified by stability data because saponin-rich botanical powders can agglomerate and darken. Hydrolysis is accelerated when the granulating fluid is acidic or when the wet mass is held for more than 30 min before drying. Pilot studies indicate that a drying endpoint below 5.0% moisture is preferred for granule storage, but overdrying below 2.0% can make the granules friable. If wet granulation is required, a low-shear granulator with a binder spray rate calibrated to the powder's water absorption capacity reduces overwetting and case hardening. Alternative dry granulation by roller compaction avoids water exposure and is suitable for formulations that buffer poorly.
Marker stability in finished products should be followed by a stability-indicating high-performance liquid chromatography method; a loss of marker content greater than 10% relative to initial during accelerated storage at 40°C and 75% RH signals a formulation or packaging weakness. However, the specified marker is only one chemical surrogate; changes in the non-marker fraction may influence clinical effect and are harder to quantify. Therefore, the powder's shelf life should not be assigned solely from marker content. Real-time stability under the intended packaging is required for each finished dosage form.
Field experience with botanical APIs indicates that low-shear blending is the most common source of content uniformity failure. A twin-shell V-blender or double-cone blender operating at fill levels above 60% of vessel volume may develop dead zones when the botanical powder has a cohesive fraction. If the D90 exceeds 200 µm, coarse particles migrate to the surface or to the discharge port during rotation, producing superpotent or subpotent samples. Anchorless statements about mixing should therefore be replaced with an acceptance criterion: uniformity of blend samples by high-performance liquid chromatography should show relative standard deviation below 5.0% for the marker. If the relative standard deviation exceeds this, the powder should be milled, the blender load should be reduced, or a high-shear pre-blend step should be introduced before final lubrication.
Production-scale equipment behavior also shows that stainless steel contact surfaces are preferred; carbon steel can introduce iron contamination detectable by elemental impurity testing. For premix production, a horizontal ribbon blender with a spray bar for liquid binder should be cleaned between batches to prevent cross-contamination with ionophores or antibiotics. Cleaning validation for botanical residues requires a visual and analytical check because color or odor alone is not a reliable indicator. The powder should be stored in closed containers below 25°C and below 60% RH; if storage above 60% RH occurs, pre-drying may be required before tablet compression to reduce picking and sticking.
Intended therapeutic categories are governed by the finished product registration and not by the API alone. In traditional veterinary formularies, Baitouweng San is classified as a clearing-heat and cooling-blood preparation used in gastrointestinal disorders of swine, poultry, and rabbits. Modern label language must be authorized by the registration authority; the API supplier is not responsible for clinical claims on finished products. For feed medication, the inclusion rate must be calculated from the marker content of the specific lot and the species-specific daily dose; a fixed percentage without lot correction may underdose or overdose the active fraction.
Solutions for oral drench or drinking water require solubility screening. The native powder is only partially water-soluble; undissolved solids can settle and clog drinking-water medicators. For such applications, a clarified extract or a sieved fraction may be more appropriate. If the powder is used directly in water, a dispersing agent and continuous stirring are required; sedimentation volume after 24 h should be measured and controlled. Published data for this specific powder in drinking-water systems is limited.
