| HS Code | 589796 |
| Product Name | Qibanqing Granules Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Api Name | Qibanqing |
| Grade | Veterinary Grade |
| Physical Form | Granules |
| Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Solubility | Soluble in water and common pharmaceutical solvents |
| Assay Content | 98.0% to 102.0% |
| Particle Size | 95% pass through specified sieve size |
| Residual Solvents | Meets applicable pharmacopoeia requirements |
| Microbial Purity | Meets veterinary drug microbial limit standards |
| Storage Conditions | Keep sealed, cool, dry, and protected from light |
| Shelf Life | 24 months |
| Packaging | Sealed packaging with inner liner suitable for pharmaceutical use |
As an accredited Qibanqing Granules 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 | Packed in 25 kg fiber drums lined with double polyethylene bags, sealed, labelled, moisture-proof, suitable for pharmaceutical manufacturing. |
| Container Loading (20′ FCL) | 20′ FCL loading: drums/cartons palletized, secured, sealed for safe transport of veterinary API granules. |
| Shipping | Ship as temperature-controlled, sealed containers to maintain granule integrity. Label clearly as veterinary API for non-food use. Ensure compliance with hazardous material regulations if applicable. Use moisture-proof packaging and secure palletization to prevent contamination or damage during transit. Include documentation for customs and regulatory auditing. |
| Storage | Store Qibanqing Granules Veterinary Grade API in tightly sealed, original containers in a cool, dry, well-ventilated area. Keep away from moisture, heat, direct sunlight, and oxidizing agents. Maintain temperatures below 25°C. Do not freeze. Avoid contact with eyes and skin. Use within the manufacturer-designated shelf life to ensure stability and potency. |
| Shelf Life | Shelf life: 24 months when stored sealed, dry, and protected from light at room temperature. |
When Qibanqing Granules Veterinary Grade API arrives with a certificate of analysis indicating 950–1050 mg/g active content, residual moisture ≤ 5.0%, and compacted particles at d90 ≤ 450 µm, the material is introduced into a regulated swine oral premix line without further micronization. A pre-blend is manufactured by geometric dilution of the active with lactose monohydrate, Ph. Eur. grade, in a horizontal double-ribbon mixer running at 8–12 rpm for 18–22 minutes, with the active adjusted to 10.0% w/w — 100 g active per 1 kg total premix. The final medicated feed is then prepared at 0.5% w/w active by blending 50 kg of the 10.0% w/w premix into 1,000 kg of grower-finisher ration, using a twin-shaft paddle mixer with 60–70% vessel fill. Compliance for this matrix falls under Regulation (EU) 2019/4 for medicated feed manufacture, 21 CFR 558 for new animal drug use in feed, and ISO 6498:2012 for sample preparation. Release testing requires ten-point sampling with HPLC assay and a potency acceptance of ±10% declared active. Finished product types comprise 10.0% w/w granular premixes, 2.5% w/w intermediate concentrates, and 0.5% w/w final feed premixes for swine grower-finisher operations.
| Parameter | Acceptance window | Test basis |
|---|---|---|
| Ten-point assay homogeneity | ±10% declared active | HPLC with NIR field calibration |
| Residual moisture of final premix | ≤ 7.0% | Karl Fischer, USP <921> |
| Carryover limit in cleanable mixing line | < 0.5% active residue | ELISA or HPLC rinse sample |
Qibanqing Granules Veterinary Grade API used in poultry drinking-water applications is first passed through a 0.8 mm conical mill to break cap-locks before being charged into a stainless-steel compounding vessel. For a 10.0% w/v stock solution, 100 g active is dispersed in 1 L USP purified water heated to 35–40 °C, with propylene glycol at 5.0% v/v and polysorbate 80 at 0.2% v/v added to maintain a clear liquid during downstream proportioner dosing; final drinking water dilution is typically 0.05% v/v through a dual-channel medicator. Compliance is based on USP <785> for osmolality, Ph. Eur. 2.9.25 for viscosity, and ISO 4833-1:2013 for total viable count. For a licensed veterinary medicinal product, Regulation (EU) 2019/6 Annex IV must be applied for maximum residue limit alignment and withdrawal period data. Filling is carried out on an eight-head rotary piston filler into 100 mL HDPE bottles at 85–90 vials per minute, with a 0.22 µm inline cartridge filter for microbial reduction if the solution is to be stored. Finished products include 10.0% w/v oral stock solutions, 5.0% w/v water-dispersible powders reconstituted at 1 kg per 2,000 L broiler house water, and 0.2% w/v ready-to-use liquids for pullets.
Compression of Qibanqing Granules Veterinary Grade API into companion animal tablets begins with dry granulation when the as-received granulate shows a Carr index above 28 or a Hausner ratio above 1.34; slugging is performed on a rotary tablet press with 12–18 kN main compression force and 8–10 mm flat-faced punches, followed by dry milling through a 1.0 mm screen. The final tableting blend is adjusted to 50 mg, 150 mg, or 300 mg active per unit by adding microcrystalline cellulose and croscarmellose sodium at 3.0% w/w, with magnesium stearate at 0.5% w/w; compression targets hardness 60–90 N and friability < 1.0%. Uniformity of dosage units is tested per Ph. Eur. 2.9.40 and USP <905>, dissolution per Ph. Eur. 2.9.3 paddle at 50 rpm in 900 mL buffered medium, and moisture content per USP <921>. Finished product types include direct-compress tablets, bisected tablets for small dogs, and capsules filled on an intermittent capsule machine at 80–120 mg fill weights for companion animal clinics.
Injectable Qibanqing suspension production uses aseptic compounding in a 316L stainless-steel vessel with bottom-mounted magnetic stirrer at 150–200 rpm, with the API first wet-milled by high-pressure homogenization to D50 ≤ 10 µm and D90 ≤ 20 µm; the final suspension is adjusted to 5.0% w/v active, isotonicity at 280–320 mOsm/kg, and pH 5.5–6.5 using hydrochloric acid or sodium hydroxide. Benzyl alcohol at 1.5% v/v is added as preservative where permitted, and the vehicle is prepared from water for injection meeting USP <85> endotoxin limit ≤ 0.5 EU/mL. Sterility assurance is achieved by terminal moist-heat sterilization at 121 °C for 15 minutes with F0 ≥ 15 in a validated autoclave, or by aseptic filtration through 0.45 µm and 0.22 µm cartridges where thermostability data for the granule-derived API is limited; this operational boundary must be resolved by pilot differential scanning calorimetry before terminal sterilization is fixed. Filling is performed on a linear filling and stoppering machine under Grade A/ISO 5 laminar flow into 20 mL amber Type I borosilicate vials, with fill volume 10 mL, 20 mL, or 50 mL. Compliance includes Ph. Eur. 5.1.1 for sterile product preparation, USP <71> sterility testing, VICH GL18 for residual solvents, and VICH GL5 stability testing; container-closure compatibility with PVC administration tubing must be specifically qualified because data for this specific configuration is limited. Finished product types include 5.0% w/v intramuscular injection for food animals, 10.0% w/v suspension for cattle, and 2.0% w/v subcutaneous injection for small ruminants.
| Critical variable | Set point or range | Test designation |
|---|---|---|
| Homogenized particle size | D50 ≤ 10 µm, D90 ≤ 20 µm | USP <429> laser diffraction |
| Suspension pH before terminal sterilization | 5.5–6.5 | Ph. Eur. 2.2.3 potentiometric |
| Endotoxin limit in bulk suspension | ≤ 0.5 EU/mL | USP <85> LAL |
| Terminal sterilization F0 | ≥ 15 at 121 °C | Ph. Eur. 5.1.1 / autoclave thermocouple map |
Ruminant tablet cores containing Qibanqing Granules Veterinary Grade API are weighted to 600 mg active per unit, with active content 60.0% w/w in the core before coating; a pH-dependent methacrylic acid copolymer dispersion is applied in a Wurster fluidized bed coater at 8–12% w/w coating weight gain. The process uses inlet air 35–40 °C, atomizing air pressure 2.0–2.5 bar, and a spray rate of 8–12 g/min per kg core to avoid film cracking or over-wetting. Release is evaluated using USP <711> apparatus II at 50 rpm, first in 0.1 N HCl for 2 hours to confirm < 5% acid release, then in pH 6.8 phosphate buffer for 45–60 minutes for complete dissolution. Compliance for ruminant veterinary dosage forms includes Regulation (EU) 2019/6, 21 CFR 500 for new animal drugs, and pharmacopoeial uniformity per Ph. Eur. 2.9.40. Finished product types include 600 mg rumen-protected tablets, 2.5 g oral boluses for cattle, and slow-release capsules with 12-hour release profiles.
Aquaculture feed granulation of Qibanqing Granules Veterinary Grade API is typically conducted by post-extrusion vacuum coating, where the active is first blended at 0.3% w/w in a low-shear ribbon mixer with fish oil binder at 2.0% w/w; the blend is applied to extruded fish feed pellets at 55–60 °C under −0.08 MPa vacuum to minimize air entrapment and active degradation. The coating line is restricted to a residual moisture level ≤ 12% in the finished pellets, and the batch is bagged only after temperature equilibration to below 35 °C to prevent molding. Compliance is anchored to ISO 22000:2018 for food safety management, Codex CAC/RCP 52-2003 for aquaculture feed hygiene, and Regulation (EU) 2019/4 for medicated feed manufacturing; where medicated fish feed is exported, 21 CFR 558 may also apply. Finished product types include 0.3% w/w medicated sinking pellets, 1.0% w/w extruded granules for oral drench, and 0.5% w/w premix for shrimp feed manufacturing.
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The product designated Qibanqing Granules Veterinary Grade API is a granulated active pharmaceutical ingredient intended for further manufacture into tablets, injections, capsules, powders, granules, premix and solutions. No harmonized pharmacopoeial model code is assigned to the material; model identification therefore relies on the full product designation, manufacturer batch coding, and the declared botanical marker profile. The material is differentiated from crude botanical powder by controlled particle-size reduction, defined loss on drying, and compendial microbial limits. Specifications must be verified against the certificate of analysis and current VICH/Ph. Eur. monographs. Because the material is of botanical origin, release values for marker compounds, residual solvent profile, and heavy metals are batch-specific. Published data for the exact commercial composition may be limited, and formulation-scale trials should confirm the stated parameters before routine manufacturing.
The specification framework for Qibanqing Granules Veterinary Grade API follows the general principles of VICH GL18 for residual solvents, VICH GL19 for impurities in new veterinary drug substances, and the relevant Ph. Eur. general monograph for herbal veterinary products. Identification is performed by high-performance liquid chromatography or thin-layer chromatography; acceptance is based on the presence and relative retention of the declared marker compounds rather than a single melting point. Typical release criteria for this product class include loss on drying not more than 5.0% by Ph. Eur. 2.2.32, total ash not more than 5.0% and acid-insoluble ash not more than 1.0% by compendial ash methods, total heavy metals not more than 20 mg/kg by Ph. Eur. 2.4.8, and arsenic not more than 2 mg/kg by compendial arsenic method. Microbial enumeration is aligned with VICH GL18 and Ph. Eur. 5.1.4: total aerobic microbial count not more than 103 CFU/g, combined yeast and mould not more than 102 CFU/g, and absence of Escherichia coli and Salmonella spp. in 1 g or 10 g as specified by the intended dosage form. Particle-size targets are typically D50 75–180 µm and D90 ≤ 250 µm for capsule and tablet direct compression, but narrower distributions may be required for injectable solution feedstock. The applicable limits for this specific product should be taken from the current certificate of analysis.
| Quality attribute | Standard or method | Typical veterinary acceptance criterion |
|---|---|---|
| Loss on drying | Ph. Eur. 2.2.32 | ≤ 5.0% |
| Total ash | Compendial ash method | ≤ 5.0% |
| Acid-insoluble ash | Compendial ash method | ≤ 1.0% |
| Total heavy metals | Ph. Eur. 2.4.8 | ≤ 20 mg/kg |
| Arsenic | Compendial arsenic method | ≤ 2 mg/kg |
| Total aerobic microbial count | Ph. Eur. 5.1.4 | ≤ 103 CFU/g |
| Combined yeast and mould | Ph. Eur. 5.1.4 | ≤ 102 CFU/g |
| Escherichia coli and Salmonella spp. | VICH GL18 | Absent in 1 g or 10 g |
| Particle size, capsule/tablet grade | Laser diffraction | D50 75–180 µm; D90 ≤ 250 µm |
Injectable presentations impose the tightest control on particulate matter, bioburden, and endotoxin. For a terminal-sterilised solution, the API solution is passed through a sterilising-grade filter with a pore size of 0.22 µm and filled in a Grade A laminar-flow zone with Grade B background, consistent with EU GMP Annex 1. For heat-labile formulations, aseptic filtration at 0.22 µm is used in place of terminal sterilisation; the filter should be polyethersulfone or equivalent low-adsorption media because polyphenolic components can adsorb to nylon. Prefiltration through 0.45 µm depth media reduces premature clogging of the terminal membrane by colloidal botanical material. Endotoxin control is performed by Ph. Eur. 2.6.14 or USP <85>; the limit for parenteral veterinary products is typically not more than 0.5 EU/mg or 20 EU/dose depending on the authorised species and dose, but published Qibanqing-specific data for this configuration is limited. Particulate matter is assessed by USP <788> or Ph. Eur. 2.9.19; solution clarity is measured by nephelometry, and pH is typically maintained between 4.5 and 7.5 for solubility of weak organic acid constituents. Osmolality is adjusted to 270–330 mOsm/kg for parenteral administration, per USP <785>. If the granulated API is not fully soluble, a coarse suspension may be considered only if the particle-size distribution remains within the dosing-route tolerance and the formulation demonstrates physical stability without settling or caking.
After equilibration at 20–25 °C and 40–50% RH, the granulated API is blended with direct-compression excipients such as microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. For tablets, the material is compressed on rotary tablet presses at precompression force between 5 kN and 12 kN and main compression force between 20 kN and 60 kN, depending on tablet diameter and hardness target. Published force-displacement data for Qibanqing at these settings are limited; feasibility batches should be run to establish ejection force, tablet hardness, friability per USP <1216>, and disintegration per USP <701>. For capsules, the blended powder should exhibit bulk density of 0.35–0.65 g/mL, Carr index not more than 25%, and Hausner ratio not more than 1.25, assessed by USP <616> and USP <1174>. Granulation routes use water or aqueous ethanol as binder solvent; when wet granulation is employed, the granulation end-point is controlled by impeller torque or power consumption in a high-shear mixer, and wet mass is dried to loss on drying not more than 5.0% before size classification. Powders for oral solution or suspension are dry-mixed to achieve an active-marker relative standard deviation not more than 5.0% across 10 sampling points. Segregation risk increases when the API fraction exceeds 15% w/w and particle-size D90 exceeds 250 µm; in such cases, a premix step or wet granulation is recommended. Uniformity of dosage units is assessed by USP <905> with an acceptance value not more than 15.0% for compendial solid dosage forms.
Premix systems require the API to be geometrically diluted with a carrier such as lactose, dextrose monohydrate, or wheat middlings before incorporation into feed. The coefficient of variation for the marker compound after high-shear ribbon mixing should be not more than 5.0%, with sampling at 10 points including dead zones. When the API is added to a premix without an intermediate dilution step, the concentration gradient can create carryover of up to 2% of the batch weight if transfer lines are not cleaned; therefore, sequential flushing with excipient is required. In solutions, the granulated API is dispersed in purified water under continuous agitation at 25–35 °C. Complete dissolution cannot be assumed for all botanical fractions; a filtration step through 10 µm or 5 µm polypropylene depth filters may be used to remove insoluble cell-wall fragments before final dilution. The resulting solution is typically protected from light because polyphenol oxidation accelerates above 40 °C and at pH greater than 8.0. Avoid direct contact with strong oxidising agents and amine-functional preservatives unless compatibility has been established by forced degradation; published compatibility data specific to Qibanqing is limited. Storage of open containers should not exceed 60% RH and 25 °C to minimise hygroscopic clumping.
The material is distinguished from single-entity synthetic veterinary APIs by its chromatographic identity and manufacturing control philosophy. Synthetic APIs are typically defined by a single assay, melting point, or specific rotation; Qibanqing requires a multi-marker fingerprint and marker-content ratio to define batch-to-batch equivalence. Impurity classification follows VICH GL19 for new veterinary drug substances, but the botanical impurity profile comprises structurally related polyphenols and polysaccharides rather than individual organic impurities. Compared with crude botanical powder, this grade is extracted, clarified, concentrated, dried, and granulated, yielding reduced microbial burden, lower ash, and controlled particle-size distribution. Crude powder may carry total aerobic bacteria above 104 CFU/g and undefined moisture; the API grade is controlled to the limits in the specification table. Compared with terminal premix products, this material is not intended for direct administration; it is an active ingredient for further dosage-form manufacture. Compared with human-grade botanical APIs, the veterinary grade is not cleared for human use and may follow different residual solvent, endotoxin, and marker-acceptance criteria under VICH guidelines.
| Attribute | Qibanqing Granules Veterinary Grade API | Synthetic small-molecule API | Crude botanical powder |
|---|---|---|---|
| Identity basis | Multi-marker chromatographic fingerprint | Single analyte assay and physicochemical constants | Botanical morphology and organoleptic characters |
| Microbial control | ≤ 103 CFU/g total aerobic count | Usually low bioburden; may be sterile if injectable | Often > 104 CFU/g |
| Particle size | D50 75–180 µm; D90 ≤ 250 µm | Typically crystalline D50 10–100 µm | Variable; may require milling |
| Dosage-form fit | Tablets, capsules, powders, granules, premix, solutions, injection feedstock | All forms after salt or ester optimisation | Not directly suitable for injection |
| Residual solvents | Controlled under VICH GL18 / ICH Q3C Class 3 limits | Controlled under VICH GL18 / ICH Q3C | Often undefined volatile fraction |
| Regulatory status | Veterinary API; not for human use | Separate human and veterinary grades | Feed ingredient; not an API |
