| HS Code | 840828 |
| Product Name | Chuanban Yulian Pills Veterinary Grade API |
| Api Classification | Veterinary-grade plant-derived active pharmaceutical ingredient for oral and parenteral formulations |
| Physical Appearance | Fine, free-flowing yellowish-brown to brown powder with a characteristic herbal odor |
| Active Substances | Standardized mixture of berberine, palmatine, jatrorrhizine and related alkaloids from the Chuanban Yulian herbal complex |
| Solubility | Slightly soluble in cold water; soluble in hot water, dilute ethanol and aqueous alkaline solutions |
| Applicable Dosage Forms | Tablets; injections; capsules; powders; granules; premix; solutions |
| Mechanism Of Action | Exerts antimicrobial, anti-inflammatory and intestinal mucosal protective effects by inhibiting bacterial adhesion and reducing pro-inflammatory cytokine release |
| Clinical Indications | For prevention and treatment of bacterial enteritis, diarrhea and respiratory tract infections in livestock, poultry and aquatic animals |
| Quality Standards | Meets veterinary pharmacopoeia requirements for identification, assay, loss on drying, heavy metals, microbial limits and residue solvents |
| Storage And Shelf Life | Preserve in well-closed, light-resistant containers in a cool, dry place; shelf life is 24 months under recommended storage conditions |
| Packaging Specification | Available as 1 kg, 5 kg and 25 kg sealed drums with double polyethylene bag liners |
| Handling Safety | Wear protective gloves, dust mask and safety goggles during handling; avoid direct inhalation and skin contact |
As an accredited Chuanban Yulian Pills Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Packaged in sealed, moisture-proof 25 kg fiber drums with double polyethylene liners for safe veterinary API transport and storage. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Chuanban Yulian Pills veterinary-grade API, securely packed for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Shipments of Chuanban Yulian Pills Veterinary Grade API are packed in sealed, moisture-proof containers to maintain stability and potency. Transport complies with hazardous-material and veterinary pharmaceutical regulations, with temperature-controlled options. Ensure dry, ventilated conditions, avoid direct sunlight, and clearly label for animal-use-only. |
| Storage | Store in a cool, dry, well-ventilated area, away from direct sunlight, heat, and moisture. Keep the container tightly sealed when not in use. Protect from contamination and incompatible substances. Avoid freezing unless otherwise specified. Ensure proper labeling, and store securely, out of reach of children and animals. |
| Shelf Life | Shelf life is 24 months when stored unopened in a cool, dry place, protected from light and moisture. |
In swine feed manufacturing, Chuanban Yulian Pills Veterinary Grade API is not introduced into the final ration directly; it is first converted into a 1:100 intermediate pre-blend on acid-washed diatomaceous earth screened to 250–710 μm using ISO 3310-1 sieves. The batch record requires geometric dilution because the active botanical markers segregate along bulk-density fault lines when the API exceeds 5.0% w/w of the pre-blend mass, a limit confirmed by marker-depleted core samples taken from the mixer discharge. A ribbon mixer with working capacity of 500–1000 L is operated at 15–20 rpm for 10–12 min; extended mixing beyond 20 min increases electrostatic adhesion to stainless steel walls and lowers marker recovery by as much as 8%. Bulk density of the pre-blend is adjusted to 0.55–0.75 g/cm³ to match ground corn and soybean meal in final rations. Loss-on-drying is maintained below 7.0% w/w; higher residual moisture triggers fungal amylase activity during storage. The pre-blend is let down through a bin discharger with screw feeder accuracy of ≤ 2% relative standard deviation per batch record. Swine final feed is sampled from not fewer than 10 points per batch and assayed by HPLC-UV at 254 nm under a stability protocol aligned with VICH GL3 light and heat conditions. Inclusion rates are not fixed by a public pharmacopoeial monograph for this API; dietary concentration is calculated from the batch certificate marker content and the target oral dose validated by the prescribing veterinarian. Terminal finished products include grower-finisher premix, sow transition premix, and creep feed top-dress.
Water-soluble powder and liquid concentrate forms for broiler and layer houses are governed by the API dissolution profile in hard water with total dissolved solids of 150–300 mg/L as CaCO₃. The active botanical salts dissociate poorly above pH 7.8; therefore the manufacturer acidifies drinking water to pH 4.2–6.0 with citric acid or phosphate buffer before API introduction. High-shear mixing at 800–1200 rpm for 5 min is used in the proportioner tank. A stock solution is prepared as 2–5% w/v and then dosed through a medicator at 1:100 to 1:200 dilution into the barn water line. Residual chlorine above 2 ppm must be quenched with sodium thiosulfate because oxidation of phenolic markers reduces HPLC recovery. Turbidity after 24 h at 25°C is kept below 10 NTU; higher turbidity indicates precipitation of poorly soluble aglycones. An ORP electrode in the bulk tank is maintained at +150 to +250 mV, and a 80-mesh inline screen protects the proportioner from insoluble leaf fragments. Terminal products include water-soluble sachets, 100 g/1000 L stock solutions, and automated proportioner concentrates. Residual solvent compliance follows VICH GL18, with Class 2 solvents capped at 0.6% w/w.
Parenteral use demands apyrogenicity and subvisible particulate control. The API is dissolved at 30–40°C in Water for Injection with 0.8–1.2% w/v sodium chloride or 4.5–5.5% w/v dextrose to achieve osmolality of 280–330 mOsm/kg. pH is adjusted to 5.0–6.5 with citric acid or disodium phosphate because precipitated aglycones form below pH 4.0. The bulk solution is first passed through a 0.45 μm nylon prefilter, then through a 0.22 μm polyethersulfone sterilising membrane under nitrogen pressure not exceeding 2.0 bar. Differential pressure across the sterilising filter is monitored to detect gel blockage from residual polysaccharides in the botanical matrix. Moist heat sterilisation at 121°C for 15 min is acceptable only if the marker compound degrades less than 5%; otherwise aseptic filtration followed by filling in a laminar-flow isolator is used. The glass vials are depyrogenated at 250°C for 45 min before filling. Terminal product is a 100 mL multi-dose bottle with benzyl alcohol at 1.0% w/v. Subvisible particulate acceptance follows USP <788>: not more than 6000 particles ≥ 10 μm and 600 particles ≥ 25 μm per container. Bacterial endotoxins are controlled per Ph. Eur. 2.6.14, with a typical veterinary intravenous limit of 5.0 EU/kg body weight per hour. Production equipment consists of a 14.5 L jacketed glass-lined reactor and a peristaltic filling line; the key batch bottleneck is the API lot-to-lot extractable solids variance of ≥ 5%, which requires assay-based adjustment of input mass before compounding. Bulk solution viscosity at 25°C is retained in the range 1.1–1.6 mPa·s; values above this interval indicate polymer contamination or premature aggregation.
During direct compression of 100 mg and 250 mg veterinary tablets for dogs, Chuanban Yulian Pills Veterinary Grade API exhibits cohesive failure along the punch face when the powder moisture content exceeds 5.0% w/w. The wet granulation route uses 5% w/w povidone K-30 in isopropanol and drying at 45°C to a loss-on-drying of 2.0–3.5% w/w. Lubrication with magnesium stearate is limited to 0.5–1.0% w/w because hydrophobic film formation delays disintegration beyond the 45 min veterinary limit. Tablet hardness is set at 40–70 N, and friability is held below 1.0% per USP <1216>. Dissolution in 0.1 M hydrochloric acid at 37°C requires not less than 70% marker release at 30 min using USP <711> Apparatus II at 50 rpm. Immediate-release tablets also meet USP <701> disintegration in purified water at 37°C within 15 min. If the API is moisture-intolerant, dry granulation by roller compaction at 30–60 kN with a 1.0 mm screen yields granules with bulk density of 0.45–0.55 g/cm³. Content uniformity follows USP <905> acceptance value not more than 10.0. Excipients include microcrystalline cellulose, lactose monohydrate, and croscarmellose sodium at 2.0% w/w. Terminal products include scored 100 mg and 250 mg tablets blister-packed in PVC/PVDC.
Thermal treatment during aquafeed extrusion at 105–135°C for 20–40 s obliges the formulator to apply the API after pellet cooling rather than pre-mixing it into the meal. The API is suspended in fish oil or soy lecithin at a ratio of 1:5 to 1:10 w/w and sprayed onto cooled pellets at 35–45°C using a vacuum coater at 0.4–0.6 bar. Marker retention exceeds 85% after 24 h in aerated freshwater tanks at 28°C when 3% w/w sodium alginate is incorporated as a binder. Coated pellet moisture is kept below 8.5% w/w; above this threshold, lipid oxidation initiates and accelerates API marker loss over 60-day warehouse storage. Oil uptake is checked by Soxhlet extraction per ISO 6492; oil retention above 6% w/w causes pellet softening and API leaching into pond water. Post-coating must be completed within 4 h of extruder discharge to prevent moisture migration from wet pellets into the lipid coat. Terminal products include 2–4 mm sinking pellets, top-dress powder, and extruded floating feed. Feed sampling follows ISO 6497 procedures with 10 incremental points per lot.
Wet granulation of Chuanban Yulian Pills Veterinary Grade API for calf oral drench requires a binder solution of polyvinylpyrrolidone in purified water at 8% w/v. The granulate is forced through a 1.0 mm screen and dried on a fluidised bed at 55–65°C until residual solvent content complies with VICH GL18. Fluid-bed airflow is maintained at 1.5–2.5 m/s and product temperature is not allowed to exceed 65°C to avoid caramelisation of residual sugars in the botanical matrix. The final particle size distribution is 150–850 μm, with fines below 75 μm limited to less than 10% w/w to avoid dusting losses in the dairy barn. When suspended in water at 50 g/L, the product settles within 3 min; addition of 0.5% w/w xanthan gum extends suspension time to 20 min and prevents fish-eye dispersion when the gum is pre-blended with the API before wetting. Terminal products include 10 g/100 g oral drench, 500 g bulk jar, and 25 kg multiwall pre-mix bag. Chemical stability follows VICH GL1 bracketed storage conditions for Zone II climates, with an open-container study at 30°C/65% RH.
Equine capsule fill weight is constrained by gulp transit and the dissolution profile. The API is blended as a 1:10 trituration with anhydrous lactose and filled into size 0 hard gelatin capsules at 250 mg API per capsule. Powder flow is improved with 1% w/w colloidal silicon dioxide; a Carr index of 18–22% is achieved at 30% RH. The lactose trituration is pre-screened through 180 μm before blending to prevent demixing in the hopper. Capsules are banded to prevent moisture ingress during stable storage. Dissolution in pH 1.2 simulated gastric fluid with pepsin is conducted per USP <711> Apparatus II at 50 rpm, with not less than 70% marker released at 45 min. Disintegration follows USP <701> in purified water at 37°C; complete rupture must occur within 15 min. Terminal product is the 250 mg capsule in high-density polyethylene jars with desiccant. Published data for this specific configuration in equine clinical use is limited; the formulation is restricted to pharmacy-compounded or prescription-only distribution under veterinary supervision.
The matrix below consolidates analytical and control references applicable to each downstream route. Where a public monograph for this specific API is limited, the listed standards govern the general dosage form, residual chemistry, and sampling procedure.
| Dosage route | Governing standard | Test condition | Limit |
|---|---|---|---|
| Swine feed premix | ISO 3310-1, VICH GL3 | HPLC-UV at 254 nm, mixer discharge sampling | Moisture < 7.0% w/w; API pre-blend ≤ 5.0% w/w |
| Poultry drinking-water solution | VICH GL18 | High-shear mixing 800–1200 rpm | pH 4.2–6.0; turbidity < 10 NTU |
| Bovine injectable | USP <788>, Ph. Eur. 2.6.14 | Sterile filtration 0.22 μm | Osmolality 280–330 mOsm/kg; ≥ 10 μm particles ≤ 6000/container |
| Canine tablet | USP <711>, USP <1216> | Dissolution 0.1 M HCl, 37°C | Release ≥ 70% at 30 min; hardness 40–70 N |
| Aquafeed extruded pellet | ISO 6492, ISO 6497 | Vacuum coating 0.4–0.6 bar | Marker retention > 85%; moisture < 8.5% w/w |
| Calf oral granule | VICH GL18, VICH GL1 | Fluidised bed 55–65°C | Particle 150–850 μm; fines < 10% w/w |
| Equine capsule | USP <711>, USP <701> | Apparatus II 50 rpm, pH 1.2 | Release ≥ 70% at 45 min; Carr index 18–22% |
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Chuanban Yulian Pills veterinary grade API is supplied as a bulk active substance rather than a finished pill dosage form. The term “Pills” in the commercial designation is a legacy label; the material is the active pharmaceutical ingredient used by veterinary manufacturing sites to prepare tablets, injections, capsules, powders, granules, premixes, and solutions. The product is identified by retention time and infrared absorption against a qualified reference standard. Where no regional pharmacopoeial monograph exists, the active substance master file applies validated chromatographic purity, residual solvent, elemental impurity, and particle size controls. The active substance is one chemical entity with no separate molecular models; the commercial grades are differentiated by physical and microbiological specifications rather than by chemical structure. Therapeutic indications for the finished products are assigned by the marketing authorization holder and are not determined solely by the active substance grade.
Release documentation includes certificate of analysis values for assay, related substances, water content, residue on ignition, residual solvents, elemental impurities, and particle size distribution. The material is released as injectable grade, oral solid grade, and premix grade. These designations are physical quality models: each grade shares the same chemical identity but is assigned distinct particle size, moisture, bioburden, and endotoxin boundaries according to the intended dosage form risk profile. The injectable grade is controlled for pyrogen and subvisible particulate risk. The oral solid grade is controlled for flowability, compressibility, and blend uniformity. The premix grade is controlled for dilution uniformity and carrier compatibility in medicated feed manufacturing.
Assay and related substances are measured by high-performance liquid chromatography with ultraviolet detection. Release criteria require 98.0–102.0% active substance on a dried basis, with any unspecified impurity limited to ≤ 0.2% and total impurities limited to ≤ 0.5%. Retention-time match against a reference standard is required. Residual solvents are controlled under VICH GL18; Class 1 solvents are not detected at the method limit, Class 2 solvents are below permitted daily exposure-derived limits, and Class 3 solvents are limited to ≤ 0.5% w/w unless justified by the manufacturing process. Elemental impurities are controlled under VICH GL37 and reported by ICP-MS. Water content is determined by Karl Fischer titration according to Ph. Eur. 2.5.12. The injectable grade is additionally controlled for bacterial endotoxins because terminal filtration or heat treatment may remove bacteria but is not guaranteed to remove endotoxins.
| Attribute | Method or Standard | Injection grade | Oral solid grade | Premix grade |
|---|---|---|---|---|
| Particle size D90 | ISO 13320:2020 | ≤ 10 µm | ≤ 75 µm | ≤ 150 µm |
| Loss on drying | Ph. Eur. 2.5.12 | ≤ 0.5% | ≤ 1.0% | ≤ 1.5% |
| Total aerobic microbial count | Ph. Eur. 2.6.13 | ≤ 10² CFU/g | ≤ 10³ CFU/g | ≤ 10⁴ CFU/g |
| Bacterial endotoxins | Ph. Eur. 2.6.14 | dose-specific | not applicable | not applicable |
| Bulk density | Ph. Eur. 2.9.34 | — | 0.35–0.60 g/mL | 0.40–0.65 g/mL |
Process conflict occurs when the injection-grade particle size is achieved by jet milling and the resulting micronized powder becomes electrostatically charged. Milling in a fluidised-bed opposed-jet mill with compressed air at 0.8 MPa and classifier speed set to target ≤ 10 µm D90 raises surface area. Exposed powder can adsorb moisture within 30 min if the room condition exceeds 35% RH. The milling chamber is therefore conditioned with dry nitrogen at ≤ 10 °C, and the product is discharged into double anti-static polyethylene liners. For the oral solid grade, pinned-disc milling under nitrogen may be used; the target D90 of ≤ 75 µm is verified by laser diffraction after every milling campaign. Published data for this specific API are limited, so mills are qualified with placebo runs to confirm no cross-contamination.
Parenteral solutions prepared from this API normally require buffering at a pH range of 4.5–6.5 before aseptic filtration through a 0.22 µm membrane. The injection-grade material is released with a bioburden count of ≤ 10² CFU/g and an endotoxin limit calculated from the intended species, dose, and route. The calculation follows the established formula of dividing the species-specific endotoxin limit by the maximum administered dose per kilogram per hour. For products where published data confirm a high safety margin, a typical in-process limit is ≤ 0.5 EU/mg. Terminal sterilisation at 121 °C for 15 min may be substituted only after degradation studies demonstrate assay loss below 0.5% after the heat cycle. The manufacturing area must maintain ISO 14644-1 Class 8 or better during solution preparation and ISO Class 5 at the point of fill. Filtration compatibility is tested with PVDF and polyethersulfone membranes because cellulose-based membranes may adsorb the active substance at low concentrations. The final solution is adjusted to an osmolality of 280–320 mOsm/kg by freezing point depression per USP 785. If the API is suspended rather than dissolved, particle size must remain ≤ 10 µm D90 and the formulation must pass syringeability assessments using an 18-gauge needle at 10 mL/min.
Tablet and capsule development begins with a particle size and flow assessment. Bulk density is typically between 0.35 g/mL and 0.60 g/mL, and the compressibility index is calculated according to Ph. Eur. 2.9.36. When the compressibility index exceeds 25%, direct compression is not recommended without the use of flow-aid combinations. A formulation of API plus microcrystalline cellulose, sodium starch glycolate, and 0.5% w/w colloidal silicon dioxide is often evaluated. Magnesium stearate is restricted to ≤ 1.0% w/w to avoid overlubrication and subsequent tablet friability failure. Compression is performed on an instrumented rotary tablet press at 20–30 kN force. Friability is tested according to USP 1216 with a limit of ≤ 1.0% after 100 revolutions. Content uniformity is tested according to USP 905 with an acceptance value limit of ≤ 15.0. During encapsulation, the powder blend is filled into hard gelatin or hypromellose capsules to a target weight variation of ±5.0%, and dissolution testing is performed with USP 711 apparatus 2 at 50 rpm in 900 mL of pH 6.8 phosphate buffer unless the marketing authorization specifies otherwise. The API should be sieved through a 500 µm screen before blending to remove agglomerates formed during storage.
In premix manufacturing, the API is first adsorbed onto a suitable carrier. Lactose monohydrate, ground corn, wheat midds, and calcium carbonate are candidate carriers. The carrier is selected based on particle size, oil absorptive capacity, and moisture content. The premix is shipped as a concentrated intermediate and is diluted at the feed mill to a final concentration such as 0.5–10 kg/t of finished feed, depending on the target species and dosage schedule. Uniformity is assessed by taking 10 samples from the mixer and analyzing active content by HPLC. The relative standard deviation across those samples should not exceed 5.0%. If granulation is required, the API can be granulated with 3.0–5.0% w/w povidone solution in a fluid-bed granulator with inlet air at 45–55 °C. The granule target size is 250–850 µm, and the drying endpoint is 1.0–2.5% moisture. Granule stability is sensitive to over-drying and to moisture uptake above 60% relative humidity. Dried granules should be packed in sealed HDPE containers with closure desiccant. Batch-to-batch variability in carrier particle size must be controlled because segregation can occur when the carrier and API particle sizes differ by more than an order of magnitude. After final feed dilution, recovery of the active substance is required to be within 90.0–110.0% of the labeled concentration, with carryover limits defined by the facility's cleanout validation.
The primary difference is the multi-route release design. A conventional veterinary API may be marketed with a single particle size specification and no endotoxin limit if it is intended only for oral powders. This product is released in injectable, oral solid, and premix grades whose physical and microbiological boundaries are assigned according to the dosage form risk profile. Human-grade active substances are not automatically acceptable for veterinary use; the veterinary regulatory pathway requires impurity and residue justifications under VICH guidance and, where applicable, residue depletion data in target food-producing species. In comparative terms, the injection grade of this API has an endotoxin and bioburden specification that is tighter than the oral solid grade. The oral solid grade is controlled for particle size and moisture to support direct compression. The premix grade is characterized by dilution uniformity and carrier compatibility rather than by tablet compressibility. Published independent studies comparing this API with other substances in identical formulation matrices are limited. However, the multi-grade framework moves particle size, endotoxin, and solvent controls upstream to the active substance manufacturer.
Material handling restrictions apply at relative humidity above 60%. The API should be dispensed in a dry room maintained at ≤ 35% RH and 15–25 °C. Contact with strong oxidizing agents, hypochlorite-based sanitizers, and amine-based additives should be avoided unless compatibility is demonstrated by forced degradation studies. Storage is in sealed HDPE containers with desiccant; the retest interval is 36 months from release date when stored below 25 °C and protected from light. Micronization must be conducted with cooled air to maintain product temperature below 40 °C; uncontrolled dry milling may alter surface energy and reduce blendability. Process cleaning must be validated to a carryover limit not exceeding 0.1% of the smallest subsequent batch size. Published data for this specific API in all species-specific medicated feed matrices is limited; process validation should confirm blend carryover, cleanout limits, and in-process hold times at the manufacturing site.
