| HS Code | 293423 |
| Product Name | Kangfuxin Solution Veterinary Grade API |
| Api Category | Active Pharmaceutical Ingredient |
| Origin | Extract of Periplaneta americana (American cockroach) |
| Physical Form | Liquid solution |
| Appearance | Brownish or yellow-brown clear liquid |
| Active Ingredients | Amino acids, peptides, nucleotides, inosine, hypoxanthine, and tissue repair factors |
| Solubility | Miscible with water and common pharmaceutical solvents |
| Ph Range | 5.0-7.0 |
| Mechanism Of Action | Promotes granulation tissue proliferation, angiogenesis, mucosal repair, and anti-inflammatory responses |
| Indications | Gastric ulcers, enteritis, wound healing, skin burns, oral and mucosal ulcers, and tissue regeneration support in veterinary medicine |
| Target Species | Livestock, poultry, companion animals such as pigs, cattle, sheep, dogs, and cats |
| Available Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and oral or topical solutions |
| Administration Route | Oral, topical, or injectable depending on the final formulation |
| Storage Conditions | Sealed, stored in a cool and dry place, protected from light |
| Shelf Life | 24 months |
| Quality Standard | Veterinary pharmaceutical grade standard |
As an accredited Kangfuxin Solution 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 | Kangfuxin Solution Veterinary Grade API is packaged in sealed, light-protected drums, 25 kg per drum, ensuring stability for various dosage formulations. |
| Container Loading (20′ FCL) | 20′ FCL loading of Kangfuxin Solution Veterinary Grade API in sealed, palletized drums; safe, stable transport for formulations into tablets, injections, capsules, powders, granules, premix, solutions. |
| Shipping | Kangfuxin Solution Veterinary Grade API ships in sealed, light-resistant containers to maintain stability. Transport under controlled temperature, avoiding heat and freezing. Use secure, leak-proof packaging with adequate cushioning. Include safety documentation and comply with local veterinary pharmaceutical shipping regulations. Ensure discreet labeling and trackable courier service for delivery. |
| Storage | Store Kangfuxin Solution Veterinary Grade API in a cool, dry, well-ventilated area, protected from direct sunlight and moisture. Keep containers tightly sealed when not in use. Avoid storage above 25°C and away from incompatible substances. Use clean, dedicated equipment. Follow manufacturer’s expiry dating and local veterinary regulations. |
| Shelf Life | Shelf life: 24 months when stored sealed, dry, and protected from light at controlled room temperature. |
In granulation lines where an ethanol-based binder is disfavored because of residual solvent documentation under ICH Q3C Class 2 limits, Kangfuxin Solution Veterinary Grade API is introduced as an aqueous binder phase at a dry-matter equivalent of 1.0–3.0 g per 100 g finished granule mass; the exact addition ratio is calculated from the batch certificate total solids value, which is controlled within ±0.5% w/w of declared dry matter. The downstream production process uses a top-spray fluid-bed granulator with inlet air temperature 55–70 °C, product temperature 30–40 °C, and a single-fluid nozzle in the 0.8–1.2 mm orifice range; at these settings the API solution viscosity remains below 15 mPa·s at 35 °C, preventing nozzle blockage during 8–12 h production campaigns. If the granulation is subsequently extruded for spheronized pellets, a twin-screw extruder with L/D 20:1 and die plate 0.8 mm is operated at 150–200 rpm, and the pellets are dried to residual moisture 2.0–3.0% w/w. Industry compliance standards applied to this application include ICH Q7 Section 8.3 for batch production records, Ph. Eur. 2.9.40 / USP <905> for content uniformity, and stability data generated under VICH stability protocols for temperate and subtropical climatic zones. Terminal finished product types are 0.5 g and 1.0 g low-density polyethylene sachets containing stomach-soluble granules, with silica gel desiccant inserted when residual granule moisture exceeds 2.5% w/w.
Sterile filtration of Kangfuxin Solution Veterinary Grade API into multi-dose injectable formats presents a narrow processing window because the peptide-rich fraction is thermolabile; terminal steam sterilization at 121 °C for 15 min is therefore excluded from standard line design. The formulation addition ratio is controlled as 20–50% v/v of the API solution in the final aqueous vehicle, with the remaining volume composed of Water for Injection, isotonicity agent, and pH buffer; osmolality is adjusted to 280–320 mOsm/kg and pH to 5.0–6.5, because outside this range soluble aggregate formation is observed during forced degradation studies at 40 °C/75% RH. If the API solution retains ethanol from extraction, vacuum evaporation at ≤40 °C is used to reduce residual ethanol below ICH Q3C Class 2 Option 2 limits before volumetric adjustment. Downstream production consists of pre-filtration through 0.45 μm polyethersulfone, followed by sterile-grade filtration through a 0.22 μm polyvinylidene fluoride cartridge; filling is executed under Grade A laminar flow with Grade B background according to EU GMP Annex 1:2022, and the maximum filtration batch size is limited by membrane protein-binding capacity, commonly validated at ≤300 mL per 10 cm² membrane area. Release testing standards include Ph. Eur. 2.6.1 sterility, Ph. Eur. 2.6.14 bacterial endotoxins ≤0.5 EU/mL, USP <787> sub-visible particulate matter, and ICH Q3D elemental impurities with a parenteral permitted daily exposure matrix. Terminal finished product types are 50 mL and 100 mL Type I glass multi-dose vials sealed with bromobutyl rubber stoppers; in-use stability testing under VICH broached shelf-life protocols supports a 28-day broached hold at 2–8 °C, subject to demonstrated compatibility between the stopper formulation and the API solution.
| Release parameter | Method | Limit |
|---|---|---|
| Sterility | Ph. Eur. 2.6.1 | No growth |
| Bacterial endotoxins | Ph. Eur. 2.6.14 | ≤0.5 EU/mL |
| Sub-visible particles | USP <787> | ≤6000/vial at ≥10 μm; ≤600/vial at ≥25 μm |
| Residual solvents | USP <467> / ICH Q3C | Class 2 limits for ethanol |
Direct compression is not feasible unless the liquid API is first immobilized, because the water content acts as a plasticizer on microcrystalline cellulose and causes capping at compression forces above 12 kN on a 16-station rotary press. Formulation addition ratio is therefore expressed on a dry solid equivalent of 5–15 mg per tablet, achieved by spray-drying the API solution onto a pre-blend of lactose monohydrate and colloidal silicon dioxide at a solids loading of 2.5–5.0% w/w. The downstream production process uses high-shear granulation with an impeller speed of 120–180 rpm and a chopper speed of 1500–2500 rpm, followed by wet sizing through a 1.0 mm screen and fluid-bed drying until loss on drying reaches 2.0–3.5% w/w. Compression is performed on a rotary tablet press with 8 mm round concave tooling; tablet hardness is maintained at 60–90 N, friability below 0.8% per Ph. Eur. 2.9.7, and disintegration below 15 min per Ph. Eur. 2.9.1. Compliance standards include VICH analytical method validation protocols, ICH Q3C for residual ethanol if the API bulk retains any co-solvent, USP <467> for residual solvents, and USP <711> dissolution with Apparatus II at 50 rpm in 0.1 M HCl for immediate-release tablets. Terminal finished product types are 50 mg and 100 mg scored tablets for companion animals, packed in cold-formed aluminum foil blisters with a moisture vapor transmission rate below 0.5 g/m²/day.
| Process variable | Set point | Method |
|---|---|---|
| Tablet hardness | 60–90 N | USP <1217> |
| Friability | <0.8% | Ph. Eur. 2.9.7 |
| Disintegration | <15 min | Ph. Eur. 2.9.1 |
| Dissolution Q | ≥80% at 30 min | USP <711> |
In poultry drinking-water powder production, a liquid API with high aqueous solubility imposes a carrier-loading ceiling because excess moisture initiates clumping in screw-auger packaging equipment. Formulation addition ratio is held at 4–8% w/w API solution on a dry carrier basis, which corresponds to a dry extract loading of 0.4–0.8 g per 100 g finished powder; the carrier is typically dextrose monohydrate pre-dried to moisture ≤0.5% w/w, and the blend is adjusted to final moisture ≤1.5% w/w before filling. The downstream production process uses a horizontal ribbon mixer with a variable-frequency drive at 15–25 rpm; the API solution is injected through a single-fluid nozzle at 2–3 bar over 20–30 min, followed by 60 min post-mixing to equilibrate adsorption onto the carrier. Industry compliance standards include Ph. Eur. 5.1.4 for non-sterile microbial quality, with a total aerobic microbial count limit of ≤10² CFU/g and absence of Salmonella in 10 g; content uniformity testing follows Ph. Eur. 2.9.40 / USP <905>. Terminal finished product types are 100 g and 500 g three-layer foil sachets or 1 kg high-density polyethylene jars with induction-sealed liners; reconstituted drinking-water stability is assessed at 25 °C for 24 h under VICH broached stability protocols.
Premix applications require the liquid API to be adsorbed onto a porous carrier that withstands mineral premix matrices containing trace elements and limestone; direct mixing with limestone fines above 5% w/w moisture can accelerate peptide degradation and should be avoided unless the carrier is pre-coated with vegetable oil at 1–2% w/w. Formulation addition ratio is set at 2–5 kg API solution per 100 kg carrier, with the carrier being maize cob flour or precipitated silica; the target dry matter distribution after mixing is 0.2–0.5 kg dry extract per 100 kg premix. The downstream production process uses a twin-shaft paddle mixer with a cycle time of 8–12 min; liquid addition is completed in the first 4 min at 8–10 rpm, and the residual moisture after 24 h equilibration is controlled at ≤10% w/w to prevent mold growth. Compliance standards include EU Regulation 2019/6 for veterinary medicinal products, and for feed-mill incorporation documentation, conformity with HACCP principles under Regulation 183/2005/EC is commonly required. For cross-border shipments, the active substance documentation should follow the Active Substance Master File procedure under EU Regulation 2019/6. Terminal finished product types are 20 kg paper-valve sacks with inner polyethylene liner, labeled for protected storage at ≤25 °C and ≤60% RH; batch-to-batch traceability is maintained by unique production order coding linked to API batch certificates.
When hard gelatin capsules are filled directly with the aqueous API solution, shell softening is observed within 30 min at 25 °C/60% RH; the liquid is therefore first converted to a free-flowing dried intermediate by spray drying on a maltodextrin or gum arabic carrier. Formulation addition ratio for the spray-dried intermediate is 10–20% w/w of the capsule fill mass, equivalent to 20–40 mg dry extract per size 1 capsule, with the remainder being mannitol, crospovidone, magnesium stearate, and fumed silica. The downstream production process uses a co-current spray dryer with inlet temperature 140–160 °C, outlet temperature 70–80 °C, and atomizer speed 18,000–22,000 rpm; the dried intermediate is milled through a 0.5 mm conical sieve and filled on an intermittent-motion capsule filler at 40,000 capsules/h. Compliance standards include Ph. Eur. 2.9.3 / USP <711> dissolution, with Q ≥ 80% at 30 min in 0.1 M HCl, and Ph. Eur. 2.9.36 for powder flow if automated capsule filling is used. Published data for the specific combination of Kangfuxin Solution Veterinary Grade API with hydroxypropyl methylcellulose capsule shells is limited; compatibility at accelerated conditions should be confirmed before commercial filling. Terminal finished product types are size 1 hard gelatin or hydroxypropyl methylcellulose capsules in polyvinyl chloride/aluminum blisters, with desiccant required when storage humidity exceeds 60% RH.
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Kangfuxin Solution Veterinary Grade API is a liquid active pharmaceutical ingredient derived from controlled aqueous extraction of cultured Periplaneta americana (Blattodea: Blattidae). It is released for further manufacture into tablets, injections, capsules, powders, granules, premix, and solutions, and it is not a finished veterinary medicinal product. The active fraction is heterogeneous, containing water-soluble peptides, free amino acids, nucleotides, and polysaccharides. Release cannot rely on a single-compound assay; control is based on a matrix of identity, total amino acid content, pH, visual appearance, microbial enumeration, residual solvent screening, and, for parenteral applications, bacterial endotoxin. Because no official international monograph exists for this veterinary-grade API, batch release specifications are established in the manufacturer’s drug master file and cross-referenced to the finished-product authorization. Model designations are manufacturer-specific; no regulatory model code is assigned. Buyers should verify that the certificate of analysis contains the internal article code, extraction solvent, source species, storage condition, and retest date. The neat liquid is miscible with water; solubility in organic solvents is limited and should not be assumed for formulation development.
Specifications for the veterinary-grade API are not identical to the human liquid monograph. The manufacturer’s specification may include a narrower pH band, a lower bioburden limit for injectable applications, and an endotoxin action limit calculated from the intended animal species and dosing route. Because the active material is a biological extract, the specification should also include residual solvent and pesticide residue screening, although published limits for this specific configuration are limited. Buyers seeking to use the API across multiple dosage forms should maintain separate release profiles: an oral-grade profile for tablets, capsules, granules, powders, and premix; and a parenteral-grade profile for injections and sterile solutions. The parenteral-grade profile adds bacterial endotoxin and sterility assurance controls to the same chemical identity markers.
The API’s function in finished products is to provide wound-healing and mucosal tissue-repair activity. In veterinary formulations, it may be incorporated into oral solutions for gastrointestinal mucosal support, topical solutions for wound irrigation, or injectable preparations where authorized. The exact dose and animal species are determined by the finished product marketing authorization; the API supplier does not define therapeutic indications. For solid dosage forms, the liquid concentrate is used as a wetting agent during granulation or as an adsorbed active phase; in solutions, it is diluted to the approved concentration and pH-adjusted.
The identification profile combines ultraviolet spectral data with amino acid analysis and a ninhydrin-positive reaction. Size-exclusion HPLC may be used to monitor molecular-weight distribution across batches. Total amino acid content is determined by acid hydrolysis followed by automated amino acid analysis; the acceptance range is dossier-defined and should not be transferred from the human pharmacopoeial liquid without bracketing. The product should be a dark brown to reddish-brown liquid, free of visible extraneous material. The pH is controlled because it affects peptide solubility, preservative activity, and hydrolytic stability. A potentiometric method is used, and the release range is justified by formulation development. Residual solvents are controlled under VICH GL18; stability protocols follow VICH GL3. Elemental impurities are tested by a validated compendial method, but published limits for this specific biological API are limited. A supplier claiming pharmacopoeial compliance should state the edition of the Chinese Veterinary Pharmacopoeia or equivalent pharmacopoeia used for the test methods.
| Parameter | Method / Reference | Control Principle |
|---|---|---|
| Appearance | Visual inspection against controlled comparator | Dark brown to reddish-brown liquid; no extraneous visible matter |
| Identity | UV spectral profile; amino acid profile | Matches reference extract of Periplaneta americana |
| Total amino acid content | Acid hydrolysis with automated amino acid analyzer | Release range defined in manufacturer dossier |
| pH | Potentiometric method | Controls solubility and hydrolysis rate |
| Microbial enumeration | Compendial microbial limit test | Route- and dosage-form-dependent |
| Bacterial endotoxin | Kinetic chromogenic LAL | Required for parenteral grade; limit based on maximum dose |
| Residual solvents | VICH GL18 | Class 1 and Class 2 solvents controlled |
| Stability | VICH GL3 | Long-term, accelerated, and in-use studies as applicable |
Supply-chain controls for this API are not reducible to a single certificate. The extraction raw material is an insect-derived biological, so the supplier should provide documentation of culture conditions, feed, and disease-control program. Lot-to-lot variability in peptide profile and amino acid composition is inherent; the finished-product manufacturer should maintain a reserve sample of each API lot and generate a potency marker across at least three lots before setting an assay limit. If a warehouse receives the neat liquid, it should be stored in closed, light-resistant containers at the temperature stated in the stability protocol. Freeze-thaw cycling should be avoided unless a freeze-thaw validation study demonstrates no precipitation or activity loss. Published data for this specific veterinary-grade API under repeated freezing are limited; therefore default storage should follow the supplier’s unopened-container recommendation.
Direct addition of the neat liquid into a tablet or capsule blend introduces moisture into a low-moisture system, causing powder clumping, feed-frame blockage on a rotary tablet press, and variable fill weight on a dosator capsule machine. Production-scale processing typically requires adsorption or drying. In one common configuration, a high-shear granulator with an impeller and chopper is charged with a carrier such as maltodextrin, microcrystalline cellulose, or colloidal silicon dioxide, and the Kangfuxin Solution is metered through a peristaltic pump and spray nozzle. The liquid addition rate is limited by the granulator load sensor and the end-use particle-size target; endpoint is determined by visual granule consistency and loss-on-drying. If the granules are to be compressed into tablets, they must be milled through a screen, commonly 850 µm, and blended with a lubricant. Tablet hardness and disintegration time then depend on the residual moisture and carrier type, not on the API concentration alone. A formulation that exhibits acceptable hardness in the laboratory may fail on a production-scale rotary press if the granule flow function is too cohesive. Flowability should be measured by a ring shear tester or a funnel flow test before compression. For capsule filling, the granule should be filled on a dosator or tamping-pin machine; sticking inside the dosator can occur if residual moisture exceeds the limit established by the capsule shell supplier. The process window is narrow because the liquid extract is hygroscopic; holding wet mass too long before drying can generate a compacted zone in the high-shear granulator and increase the load on the mill. Drying in a top-spray fluid-bed granulator with dehumidified inlet air is preferred. Tray drying above 60°C should be justified by thermal degradation data. Published data for the veterinary-grade API under high-temperature drying are limited.
For feed premix and granule applications, the liquid API is usually converted into a carrier-adsorbed powder before addition to the mixer. A production-scale ribbon blender with an intensifier bar may be used for the final premix; the liquid-loaded carrier is added after the major diluent, and mixing time is established by blend uniformity sampling. Blend uniformity should meet a coefficient of variation ≤5% for the marker, measured by a validated method at a minimum of ten sampling points. If the material is intended for drinking-water solutions, the final powder must be readily dispersible without excessive foaming. The presence of surface-active peptides in the extract can generate foam during reconstitution; a defoaming agent may be required, but its compatibility with the API must be tested. Because the API is derived from a biological matrix, mineral carriers that contain free transition metals can accelerate oxidative browning and should be evaluated in a forced-degradation study. Published data for this specific API on mineral carriers are limited.
For oral and topical solutions, the neat liquid is diluted with purified water or a buffered vehicle. The solution must be protected from light because the extract contains chromophores that can oxidize; amber glass or high-density polyethylene with a light barrier is typical. The final solution pH should be selected to maintain peptide solubility and minimize chemical hydrolysis; a pH value outside the developed stability band can cause precipitation or color shift. Terminal filtration at 0.45 µm may be used for non-sterile oral or topical solutions, while sterile solutions require 0.22 µm sterilizing-grade filtration or terminal sterilization. In solution manufacturing, foaming during mixing can reduce tank capacity; vacuum deaeration or low-shear mixing is used. The solution should be checked for clarity and color after 24 hours of storage at controlled room temperature to detect delayed precipitation.
For injectable products, the liquid API is diluted into water for injection and processed through a sterilizing-grade membrane filter. Peptide-containing liquids can foul polyethersulfone and polyvinylidene difluoride membranes; the observed flux decline depends on peptide aggregation, pH, and the presence of preservatives or surfactants. A filterability study should be conducted with the actual formulation and membrane lot. The maximum differential pressure specified by the membrane manufacturer must not be exceeded, because membrane rupture can release retained microorganisms and endotoxin. On a production-scale filling line, the total throughput per 10-inch cartridge should be verified by a bacterial retention validation study using a minimum of 107 CFU/cm2 of a suitable challenge organism. The API’s bioburden should be controlled before filtration, because sterilizing-grade filters are not intended to reduce endotoxin. If filter capacity is too low, a prefilter or a clarification step may be required; the prefilter must be validated for non-detrimental adsorption of peptides. Adsorptive losses on membrane filters can reduce total amino acid content and alter the molecular-weight profile. Therefore the filtration step should be monitored by pre- and post-filtration assays, and the acceptance criterion for yield should be established during process validation.
If terminal moist-heat sterilization is selected for the injectable or solution dosage form, the API must be tested for bioburden and bacterial endotoxin before processing. A worst-case bioburden level should be set from historical release data and challenged by validation batches. The sterilization cycle should deliver a minimum 6-log reduction of a reference biological indicator, such as spores of Geobacillus stearothermophilus, but the F0 value should not exceed the minimum needed for sterility assurance because the peptide fraction may degrade. Endotoxin is not inactivated by moist heat; therefore incoming endotoxin limits are route-dependent and must be calculated from the maximum dose volume and animal body mass. For aseptically processed injections, terminal sterilization is not used; instead the entire manufacturing chain, including filter installation and filling line assembly, is validated under cleanroom conditions. Published data for this veterinary-grade API under terminal moist-heat cycles are limited, so a thermal stability study at the intended sterilization temperature should be performed before committing to a sterilizing cycle.
The LAL test may be subject to interference from β-glucans or other extract components; the analytical method must include a positive product control and a negative water control. If interference is detected, a heat-dilution or specific endotoxin reduction step should be validated. Endotoxin removal from a peptide-containing liquid is difficult because adsorptive filters may also remove active peptides.
Kangfuxin Solution Veterinary Grade API differs from synthetic wound-healing and mucosal-protective agents in its multi-component composition. A synthetic single entity such as allantoin or sucralfate can be assayed directly and is typically less sensitive to thermal processing. The Kangfuxin API requires matrix controls and biological-source documentation; this increases the analytical burden relative to chemically defined APIs. Compared with human-grade Kangfuxin liquid, the veterinary-grade API is supplied for further manufacturing rather than direct dispensing; the critical difference is not necessarily active content but the absence of a finished-product monograph, route-specific endotoxin control, and drug master file support for veterinary authorization. Compared with other biological APIs such as enzymatic hydrolysates or yeast extracts, the Kangfuxin API is insect-derived, and its allergenic potential and protein profile require a separate safety risk assessment. Compared with recombinant growth factor APIs, the Kangfuxin API has a broader molecular-weight distribution and is not a single recombinant protein; therefore the analytical identity test cannot be a single ELISA or Western blot alone. This makes finished-product equivalence more dependent on a combination of chemical and biological assays.
The most significant operational boundary is incompatibility with strong oxidizing agents and strong acids or bases. Quaternary ammonium disinfectant compatibility has not been established in published veterinary literature, and cleaning validation should use a specific analytical method to detect residual peptide, not total organic carbon alone. If the API is held in stainless steel vessels, prolonged contact should be evaluated because peptide-rich liquids can adsorb to metal surfaces and reduce active content. Published data for this specific configuration are limited. Manufacturers should not substitute the veterinary-grade API with the human liquid without a documented bridging study covering excipients, preservatives, bioburden, and packaging leachables.
