| HS Code | 828724 |
| Product Name | Chuanku Gonglao Powder Veterinary Grade API |
| Api Status | Veterinary-grade active pharmaceutical ingredient for secondary formulation |
| Physical Form | Dry, homogeneous, fine powder |
| Color | Brown to yellowish-brown |
| Odor | Characteristic herbal odor |
| Taste | Bitter |
| Solubility | Partly soluble in water; dispersible in dilute hydroalcoholic vehicles |
| Active Phytochemicals | Standardized herbal actives including andrographolide, matrine-type alkaloids, and berberine-type alkaloids |
| Ph Range | pH 4.0 to 6.0 for a 1% aqueous dispersion |
| Assayed Content | Active marker content within 90% to 110% of labeled claim by HPLC |
| Dosage Form Compatibility | Suitable for use in tablets, injections, capsules, powders, granules, premix, and solutions |
| Storage Conditions | Store in tightly closed, moisture-proof containers below 25°C in a dry, dark place |
| Shelf Life | 24 months when stored under recommended conditions |
As an accredited Chuanku Gonglao 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 | Each package contains 25 kg of Chuanku Gonglao Powder Veterinary Grade API in sealed double bags inside a sturdy fiber drum. |
| Container Loading (20′ FCL) | 20′ FCL loading: Chuanku Gonglao Powder veterinary API, packed in moisture-proof sealed containers, palletized and secured for safe transport. |
| Shipping | Shipping of Chuanku Gonglao Powder Veterinary Grade API requires sealed, moisture-proof containers to preserve potency. Ship as non-hazardous pharmaceutical powder unless classified otherwise. Use temperature-controlled transport if specified; avoid direct sunlight and extreme heat. Include complete documentation, MSDS, and product certificates. Ensure compliant labeling for veterinary use and destination regulations. |
| Storage | Store Chuanku Gonglao Powder Veterinary Grade API in tightly sealed, original containers in a cool, dry, well-ventilated area. Protect from direct sunlight, moisture, and excessive heat. Keep away from oxidizing agents, food, feed, and incompatible materials. Ensure containers remain closed when not in use to preserve stability and prevent contamination. |
| Shelf Life | Store in a cool, dry place, protected from light. Shelf life is 24 months from manufacture date when unopened. |
Chuanku Gonglao Powder entering a tablet compression suite is first assessed for bulk density, tapped bulk density, and loss on drying because powders of this class often exhibit batch-to-batch variation in hygroscopicity. When the powder is pre-blended with microcrystalline cellulose type 102 and dicalcium phosphate dihydrate in a 1:5:4 ratio, the resulting mixture is passed through a 710 µm stainless steel screen to break loose agglomerates. The screened mixture is transferred to a 600 L bin blender and mixed at 12 rpm for 15 min; magnesium stearate is added at 0.75% w/w during the final 3 min of mixing to limit over-lubrication. Precompression force is held at 2.0–3.0 kN to evacuate air from the die cavity before main compression; turret speed is limited to 30–45 rpm because lower bulk density feeds unevenly at higher speeds. Tablets are pressed on a 27-station rotary press with a main compression force between 12 kN and 18 kN, depending on the batch granule hardness profile. In-process tablets are sampled every 15 min and tested for mass uniformity according to USP <905>, friability according to USP <1216>, and disintegration according to USP <701>. If capping occurs at press speeds above 45 rpm, the dry granulation route is substituted: the API blend is compacted on a roller compactor at a roll pressure of 25–40 bar, a roll gap of 1.5 mm, and a roll speed of 8–12 rpm, milled through a 1.0 mm mesh, and re-blended before tableting. This route is preferred for high-dose tablets because direct compression of low-bulk-density powders can cause weight fluctuation and segregation. Tablet hardness is measured with an in-line hardness tester and correlated with disintegration time; tablets are packaged in aluminium/PVC blister cavities with a desiccant pouch when bulk powder moisture uptake exceeds 3.0% in 24 h at 75% RH.
Chuanku Gonglao Powder intended for parenteral batches is not assumed sterile on receipt; the powder is sampled per USP <61> for total aerobic microbial count and per USP <85> for bacterial endotoxins before release for aseptic processing. The powder particle size distribution is checked by laser diffraction; if D90 exceeds 50 µm, a micronization step is used before dissolution. Aseptic preparation begins with dissolution of the sieved powder in water for injection at a batch temperature of 20–25°C, followed by pH adjustment with 0.1 M hydrochloric acid or 0.1 M sodium hydroxide. The solution is clarified through a 0.45 µm polyethersulfone filter and then sterilized through a 0.22 µm polyethersulfone filter under nitrogen pressure of 0.8–1.0 bar. Terminal steam sterilization at 121°C for 15 min should not be selected unless stability data demonstrate fewer than 2.0% total related substances after the cycle; published data for this specific powder under saturated steam is limited, so the terminal cycle is excluded by default in most sterile filling suites. If the injection is formulated as a suspension, the powder is reduced to a D90 below 10 µm in a high-pressure homogenizer at 600–800 bar, then incorporated into a vehicle containing polysorbate 80, sodium carboxymethylcellulose, and benzyl alcohol. The sterile filling line operates in an ISO 14644-1 class 5 unidirectional airflow zone; filter integrity is tested before and after filling by bubble point according to manufacturer specifications. Vials are depyrogenated at 250°C for 30 min before filling.
Low-dose veterinary capsules require a granulation with an angle of repose below 35° and a compressibility index below 20% to hold fill-weight variation within USP <905> limits. Chuanku Gonglao Powder is first milled through a 180 µm sieve and dry-blended with pregelatinized starch and lactose monohydrate in a planetary mixer for 10 min. A binder solution of povidone K30 in purified water is added at 2.0% w/w dry solids; the wet mass is passed through a 1.0 mm screen and dried in a fluid bed dryer with inlet air at 55–60°C until the granulate reaches a loss on drying of 2.8–4.0%. The dried granules are sized through a 800 µm sieve and lubricated with 0.5% w/w magnesium stearate. Automatic capsule filling on a dosator machine is set to a target fill weight of 250 mg per size 1 HPMC capsule. The process is adjusted based on tamping pin height and powder bed depth because low-density granulates may compact unevenly. Capsule shells are conditioned at 22–25°C and 40–50% RH to avoid brittleness. Weight checks are performed every 30 min using a 20-capsule sample; fill weight and mass uniformity data are recorded in accordance with 21 CFR 211.188(b). Disintegration is tested according to USP <701> in water at 37°C; dissolution is evaluated per USP <711> using the basket apparatus at 100 rpm in 0.1 M hydrochloric acid.
Medicated premix manufacture handles Chuanku Gonglao Powder in a low-dust environment because the powder can carry electrostatic charge and adhere to polypropylene mixing surfaces. In a 500 kg ribbon mixer, a first dilution is prepared by blending 1 part API with 9 parts spray-dried silica and calcium carbonate for 8 min. This preblend is transferred to the main mixer containing ground maize cob carrier at 25°C and mixed for 12 min; a second dilution is made by adding the preblend at 1:9 to the full carrier mass to achieve a nominal concentration of 1000 mg/kg. Homogeneity is assessed by taking 10 samples along the mixer axis and assaying active marker content with a coefficient of variation below 5.0%. Segregation is minimized by matching particle size distributions: the carrier is screened through a 1.0 mm sieve and the API preblend through a 710 µm sieve. The blend is discharged into 25 kg multi-wall paper bags with polyethylene liners and stored below 30°C. Mixer discharge is sampled at start, middle, and end of unloading to detect segregation during transfer. This premix is incorporated into pelleted feed at 2.0–5.0 kg per tonne, depending on veterinary prescription.
Oral solutions prepared from Chuanku Gonglao Powder require a defined solubility envelope because undissolved particles can settle in macro-channel drinking systems and block nipple drinkers. The powder is dispersed in warm purified water at 35–40°C and stirred with a high-shear Silverson mixer at 3000 rpm for 20 min; the dispersed system is then pH-adjusted to 4.0–5.0 with citrate buffer. A co-solvent system consisting of propylene glycol and glycerin at 10–20% v/v is added after cooling to 25°C. Clarification is performed through sequential 1.0 µm and 0.45 µm polypropylene cartridge filters, and the filtered solution is filled into amber polyethylene terephthalate bottles. Stability is evaluated under VICH GL3 conditions; antimicrobial preservation effectiveness is assessed according to USP <51> using Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. The finished solution is intended for oral drench use or for proportioner dosing pumps. A 1:100 dilution in drinking water is prepared at the farm; field water pH and hardness are recorded before use because high calcium water can reduce clarity and create nozzle deposits.
Fluid-bed granulation of Chuanku Gonglao Powder for sachet products uses a top-spray configuration with a binary nozzle atomization air pressure of 1.5–2.5 bar and a spray rate of 4–6 g/min per kg batch. The granulated material is discharged through a 1.0 mm sieve, blended with sucrose and sodium saccharin, and filled into 10 g aluminium foil sachets. Loss on drying is controlled according to USP <731>, and bulk density is checked with a tapped density tester before packaging. Granule friability is tested by rotating 10 g of granules with 100 steel balls of 5 mm diameter in a friability tester for 15 min; the fraction retained on a 500 µm sieve should be above 90%. The sachet powder is reconstituted by the end user in potable water; the reconstituted dispersion is suitable only for immediate administration because the preservation system is not designed for prolonged storage. This format is held to a pack-level moisture barrier requirement equivalent to aluminium foil laminated with low-density polyethylene at a thickness not less than 0.12 mm.
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Chuanku Gonglao Powder is released as a veterinary-grade active pharmaceutical ingredient under the manufacturer designation CKG-P-VET, with subgrades CKG-P-VET-OSD for oral solid dosage forms, CKG-P-VET-INJ for injectable solutions, and CKG-P-VET-PMX for medicated premix. The material is a free-flowing, off-white crystalline powder intended for incorporation into tablets, injections, capsules, powders, granules, premixes, and solutions. The release specification includes identification by infrared absorption against a qualified reference standard, assay by HPLC with an acceptance interval of 98.0%–102.0% on the dried basis, loss on drying not more than 1.0% by USP <731>, residue on ignition not more than 0.1% by USP <281>, and endotoxin limit assigned from the dose route according to VICH GL18. The powder is not marketed as sterile; downstream manufacturers must validate sterilizing filtration or terminal sterilization before preparing injectable products.
In oral solid-dose processing, the powder is passed through a 0.5 mm conical screen and blended in a 300 L ribbon blender at 60% capacity for 15 min before dry granulation or direct compression. Bulk density by ISO 60 ranges from 0.42 g/mL to 0.62 g/mL, which is suitable for volumetric capsule filling on a dosing-disc machine at speeds up to 50,000 capsules/h. Low-dose tablet manufacture uses geometric pre-blending with lactose monohydrate or microcrystalline cellulose; without this step, assay RSD can exceed 5.0%. Final blends are compressed on a rotary tablet press with 8 mm B-tooling to a hardness of 40 N–70 N, tested by USP <1217>, and disintegration is evaluated against USP <701>.
Laser diffraction according to ISO 13320:2020 is used for release testing. The oral solid and premix grades are controlled to a D10 of 25 µm–45 µm, a D50 of 80 µm–120 µm, and a D90 not more than 180 µm. The D90 limit reduces segregation during pneumatic transfer and screw feeding into a rotary tablet press. For medicated premix, the API is diluted with dextrose monohydrate at a 1:100 ratio in a double-ribbon mixer; sampling at the discharge chute yields an assay RSD below 3.0%. If the inclusion level falls below 1 kg API per tonne, micro-mixing with colloidal silicon dioxide at 0.5% w/w is included to prevent dead zones and carry-over. Measurement is performed on a dry-powder laser diffraction system at 2 bar air pressure, with obscuration between 0.5% and 6.0% and a refractive index selected by the batch certificate. The same method is used to compare incoming lots against the approved PSD profile; lot-to-lot shift in D50 greater than 15 µm requires revalidation of blend uniformity.
Injectable development starts with dissolution in water for injection at 20 °C–25 °C, with pH adjusted to 5.5–6.5 using 0.1 N hydrochloric acid or sodium hydroxide. The solution is filtered through a 0.22 µm PVDF membrane and filled into depyrogenated Type I glass vials. If forced-degradation studies show assay loss greater than 2.0% after 121 °C for 15 min, terminal steam sterilization is not recommended and the process is converted to aseptic filtration. Published thermal-degradation data for this specific API are limited; therefore, the F0 value must not be assumed without product-specific kinetic studies. Endotoxin content is tested by USP <85>; a limit of 0.25 EU/mg is appropriate when the maximum dose is 10 mg/kg and the route is intravenous, calculated according to VICH GL18.
The injectable subgrade CKG-P-VET-INJ is assigned a reduced bioburden specification and is not a sterile API. Bulk solution is held in a 316L stainless-steel mixing tank with 0.2 µm vent filtration and filled under Grade A laminar flow. Aseptic filtration is preferred when API concentration is below 5 mg/mL because membrane adsorption can exceed 1.0% of the dose if not evaluated with a filter-validation study. Terminal filtration is performed with a 0.2 µm nylon or PVDF membrane at 10 psi transfer pressure; pressure above 30 psi may cause filter rupture. Filter integrity is tested by bubble point method before and after filling, and any failure requires batch rejection.
For oral powders and granules, the API is blended with lactose or dextrose and agglomerated in a fluid-bed top-spray granulator with inlet air at 55 °C–65 °C and product temperature at 30 °C–35 °C. Granule moisture is held between 1.5% and 2.5% by Karl Fischer titration. Over-drying below 1.0% moisture produces friable granules and increases dusting during sachet filling. Oral solutions are prepared in purified water and preserved with 0.1% sodium benzoate or 0.15% potassium sorbate; solution pH is adjusted to 5.0–6.0 and the batch is homogenized for 30 min in a 1,000 L stainless-steel tank. Photostability is assessed under ICH Q1B; amber PET bottles are selected where the stress study shows an assay loss above 1.0%.
Residual solvents are controlled according to ICH Q3C. If the manufacturing process uses ethanol, the certificate should report ethanol below 5,000 ppm; if dichloromethane or acetone is used, levels below 600 ppm and 5,000 ppm respectively are expected unless otherwise justified in the development report. Elemental impurities are risk-assessed under ICH Q3D using the permitted daily exposure values in Table A.1.1. For the injectable grade, the assessment addresses cadmium, lead, arsenic, mercury, cobalt, vanadium, and nickel contributions. If the API is of botanical origin, arsenic is commonly monitored below 2 ppm and lead below 5 ppm by ICP-MS. Published data for this specific product configuration is limited; therefore, product-specific risk summaries should be requested from the manufacturer before use in parenteral formulations.
Microbial limits for the oral and premix grades follow USP <61> with total aerobic microbial count not more than 100 CFU/g and total combined yeasts and molds not more than 10 CFU/g. The injectable grade has an additional absence of Pseudomonas aeruginosa and Staphylococcus aureus per 1 g in accordance with the batch certificate of analysis.
| Attribute | Method / standard | Acceptance limit |
|---|---|---|
| Identification | IR absorption; HPLC retention time | Matches reference standard |
| Assay on dried basis | HPLC | 98.0%–102.0% |
| Loss on drying | USP <731> | ≤1.0% |
| Residue on ignition | USP <281> | ≤0.1% |
| Heavy metals | ICH Q3D risk assessment | As ≤2 ppm; Pb ≤5 ppm if botanical source |
| Particle size D90 | ISO 13320:2020 | ≤180 µm oral/premix; ≤100 µm injectable |
| Bulk density | ISO 60 | 0.42 g/mL–0.62 g/mL |
| Tapped density | USP <616> | 0.55 g/mL–0.78 g/mL |
| Microbial limits | USP <61> | TAMC ≤100 CFU/g; TYMC ≤10 CFU/g |
| Endotoxin for injectable grade | USP <85> | ≤0.25 EU/mg at 10 mg/kg intravenous dose |
Differences from non-sterile technical-grade powders are primarily physical and microbiological. The CKG-P-VET material is released with a controlled particle-size band, a documented cleaning validation program consistent with 21 CFR 211.67, and a lower bioburden. It is not micronized; high-energy milling is not recommended for oral solid grades because it may induce amorphous domains and increase hygroscopicity. A glidant addition of 0.5% colloidal silicon dioxide is effective when sticking occurs on high-speed rotary presses, but excess glidant above 1.0% can delay tablet disintegration by 20%–40%. In wet granulation, a binder solution of 5% povidone K30 at impeller speed 200 rpm and chopper speed 1,500 rpm for 3 min produces granules with a tapped density of 0.55 g/mL–0.78 g/mL. Over-granulation yields tablet hardness above 90 N and disintegration failure; under-granulation causes capping during compression.
Compared with injectable-grade alternatives, the subgrade CKG-P-VET-INJ is not supplied as a pre-sterilized powder. The designation indicates reduced bioburden, endotoxin control, and particle-size width appropriate for aseptic handling; it does not remove the requirement for depyrogenation and sterilizing filtration. Compared with premix-grade material, the oral solid grade is finer, with a D90 not more than 180 µm, while the premix grade may be slightly coarser to reduce dusting during feed-mill mixing. The three subgrades should not be interchanged without revalidating blend uniformity, filtration recovery, and endotoxin limits. For low-dose tablets with API concentration below 2.0% w/w, a premix of API and lactose is prepared in a high-shear mixer at 300 rpm for 5 min, followed by a final blend in a V-blender for 20 min at 25 rpm. Tablet weight variation is controlled at ±3.0%; content uniformity tested per USP <905> must meet an acceptance value not more than 15.0.
Veterinary finished products containing this API must define withdrawal periods in food-producing species based on residue depletion studies aligned with VICH GL48 or GL49. The API supplier does not assign withdrawal periods; they are established by the finished-product marketing authorization holder. Use of the oral-grade powder in parenteral formulations is not permitted without endotoxin revalidation and filter compatibility testing. The product is intended for veterinary use only and must be handled according to the safety data sheet and local regulatory requirements.
