| HS Code | 653420 |
| Product Name | Kaolinum Veterinary Grade API |
| Chemical Name | Hydrated Aluminium Silicate |
| Molecular Formula | Al2O3·2SiO2·2H2O |
| Cas Number | 1332-58-7 |
| Description | Fine, white or greyish-white, unctuous powder or mass |
| Solubility | Practically insoluble in water, ethanol, dilute acids, and alkali hydroxides |
| Ph 10 Aqueous Suspension | 5.0 to 8.0 |
| Intended Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Storage | Store in tightly closed containers in a cool, dry place |
As an accredited Kaolinum 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 | Kaolinum Veterinary Grade API for tablets, injections, capsules, etc.: packaged in 25 kg multilayer polyethylene-lined bags, clearly labelled and sealed. |
| Container Loading (20′ FCL) | One 20′ FCL container loads Kaolinum Veterinary Grade API securely on pallets, ensuring safe, dry transport for pharmaceutical manufacturing. |
| Shipping | Kaolinum (Kaolin) Veterinary Grade API is shipped in sealed, moisture-resistant containers to preserve purity and stability. Transportation complies with international safety regulations, ensuring secure handling, controlled temperature, and protection against contamination. Documentation is provided for traceability, ensuring safe, efficient delivery to pharmaceutical manufacturing facilities worldwide. |
| Storage | Store Kaolinum Veterinary Grade API in tightly sealed, moisture-proof containers in a cool, dry, well-ventilated area, away from direct sunlight and incompatible materials. Protect from excessive humidity and contamination. Ensure workplace hygiene to avoid dust generation. No special temperature requirements are necessary, but maintain controlled room temperature for optimal stability throughout its shelf life. |
| Shelf Life | Shelf life: 36 months in original unopened container, stored in a cool, dry place, protected from moisture. |
In neonatal ruminant oral antidiarrheal suspensions, the veterinary grade hydrated aluminum silicate is incorporated not as a simple viscosity modifier but as an enteric adsorbent whose flake-like morphology and cation-exchange capacity affect free-water binding, toxin adsorption, and sediment redispersibility. The formulation addition ratio for aqueous oral suspensions intended for calves, foals, and piglets is 10–20% w/v kaolin, with 20% w/v representing the practical upper plateau for pumpable and recirculatable products; above 22% w/v, shear-thinning behavior becomes pronounced and transfer loss in 316L stainless steel lines increases because the slurry forms a compact sediment when static for more than 20 min. In production, a bottom-mounted rotor-stator homogenizer with tip speed 10–15 m/s is used to deagglomerate kaolin into a prehydrated hydrocolloid phase; carboxymethylcellulose sodium or carbomer is dispersed first at 0.2–1.0% w/w, followed by the kaolin charge under vacuum deaeration at −0.08 MPa to reduce entrapped air and prevent later bottle fill-volume deviations. The process stream is transferred through a recirculation loop with 45° elbow geometry and minimum line diameter 25 mm; an in-line screen of 180 μm prevents hard agglomerates from reaching the filling nozzle, and the recirculation pump is operated at 20–40 L/min for a 500 L batch vessel to maintain suspension homogeneity without excessive platelet fracture. Because kaolin is insoluble in water, oral solution designations are technically dispersed suspensions rather than true solutions; injectable use is not a recognized veterinary downstream application for this API, and no pharmacopoeial monograph supports parenteral administration.
Industry compliance standards applicable to this dosage form include EU Regulation 2019/6 for veterinary medicinal products, 21 CFR 211.110 for in-process sampling and testing, Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13 for microbial enumeration and specified organisms, and ICH Q3D for elemental impurity risk assessment. Release testing at production scale includes apparent viscosity by a Brookfield RVDV at 20°C and 25°C, sediment volume after 24 h, and poured density; batch-to-batch variance in API particle size distribution between D50 2–8 μm and D90 15–45 μm may shift redispersibility from a single inversion to 30 min of continuous shaking. The finished terminal product types are 250 mL and 1 L HDPE suspension bottles labeled with withholding periods for food-producing animals, single-dose oral drench tubes for veal calves, and prefilled sachets for piglet and lamb rearers.
Direct-compression loading is constrained by the platy particle geometry and high specific surface area of kaolin, which reduce flow through a 10 mm funnel and induce cohesive arching in hoppers when the API fraction exceeds 30% w/w of the core tablet mass. Companion animal antidiarrheal tablets and hard capsules are therefore formulated with kaolin at 20–35% w/w in chewable tablets and 40–60% w/w in powder-filled hard capsules; below 20% w/w the kaolin contribution remains detectable but is insufficient for reliable clinical adsorption, while tablets above 35% w/w exhibit lamination and sticking on 27-station rotary presses at compaction forces above 15 kN unless roller compaction is introduced. Dry granulation through a Gerteis mini-pactor or Alexanderwerk WP 120 at specific force 4–8 kN/cm or hydraulic pressure 30–80 bar densifies the kaolin-MCC blend and raises bulk density from 0.35–0.50 g/mL to 0.60–0.75 g/mL, permitting subsequent compression with precompression force 2–4 kN and main compression 8–14 kN.
Production-scale observations document higher friability failures at ambient relative humidity above 60% because moisture uptake softens the compact; preconditioning in a fluid-bed dryer at 40°C for 30 min reduces punch sticking. Tablet friability is assessed per USP <1216> with a 100-revolution limit of 1.0% mass loss; disintegration is measured per USP <701> or Ph. Eur. 2.9.1; powder flow is characterized per USP <1174> through an 8 mm orifice. Industry compliance for marketed products includes 21 CFR 211.110, 21 CFR 211.65 for equipment construction, and EU Regulation 2019/6; elemental impurities follow ICH Q3D and microbial limits follow Ph. Eur. 2.6.12/2.6.13. The terminal finished product types are scored chewable tablets for dogs, hard gelatin or HPMC capsules for cats, and flavored oral tablets with final mass 200–600 mg.
Because oral powder administration in lambs, kids, and calves often occurs under field conditions without controlled water quality or refrigeration, the granulation step must produce dust-suppressed agglomerates that dissolve or disperse without caking in drench water at 10–25°C. The formulation addition ratio for this segment places kaolin at 50–80% w/w in the dry blend, with electrolytes, buffer salts, and a film-forming binder comprising the remainder. Wet granulation in a fluidized-bed granulator such as a Glatt GPCG uses a 2–5% w/w aqueous povidone K30 binder at spray rate 10–20 mL/min per kg dry charge, inlet air temperature 60–70°C, product temperature 30–40°C, and final moisture 1.5–3.0%; high-shear granulation is an alternative when higher granule density is needed, with impeller speed 150–300 rpm and chopper speed 1500–3000 rpm, followed by wet milling through a 1.0–1.5 mm screen.
The downstream production process continues with drying in a 50–60°C tray or fluid-bed dryer until loss on drying is below 2.0%, size classification through a 500 μm safety sieve, and packing under 40–50% RH to prevent electrostatic adhesion of fine kaolin to V-blender walls. Industry compliance standards include 21 CFR 211.110 for marketed drug products, EU Regulation 2019/6 for veterinary medicines, and USP <795> for nonsterile extemporaneous preparation; particle size distribution is confirmed by laser diffraction per ISO 13320:2020 and sieve analysis per ISO 2591-1. Terminal finished product types include single-dose 20 g and 100 g aluminum-foil oral powder sachets for feedlot calves, 500 g HDPE jars for flock administration, and reconstitutable oral solution granules yielding a 5–10% w/v kaolin dispersion after mixing in water.
Kaolin’s role in medicated premixes changes from adsorbent active to carrier or anticaking component, and the formulation addition ratio is functionally split: as a finished feed anticaking agent it is used at 1–3% w/w of total feed, while as a dry carrier diluent in trace mineral, vitamin, or medicated premixes it may comprise 30–70% w/w of the carrier fraction, depending on active loading and mixer fill volume. EU feed additive and medicated feed applications are governed by Regulation (EU) 1831/2003 for feed additives, Regulation (EU) 2019/4 for medicated feed, and GMP provisions under 21 CFR 225.1 for medicated feed premises in the United States; trace element migration is controlled under 21 CFR 211.65 where dual-use veterinary pharmaceutical and feed operations share equipment. The carrier is produced in horizontal ribbon or paddle mixers at 50–70% fill volume; ribbon tip speed is held below 1.5 m/s for friable granules and 2–3 m/s for dense mineral premixes; liquid binder such as soybean oil, propylene glycol, or molasses at 2–4% w/w is sprayed after the dry phase to reduce dust and attach fine active particles to kaolin surfaces.
Granulated premix is then formed by low-pressure extrusion through 1.5–3.0 mm dies or by compacting at roller pressures 20–40 bar, producing 0.5–1.5 mm granules for top-dress use. Production bottlenecks include premature binder droplet accumulation on fine kaolin fractions when spraying begins before dry mixing reaches uniformity, leading to 1–5 mm hard lumps that pass through the granulator and require regrinding; this is mitigated by waiting until the coefficient of variation for tracer salts is below 5% before binder addition. Terminal finished product types include vitamin-trace mineral carrier premixes, medicated premix granules for poultry and swine, and mineralized feed top-dress granules. Published data for kaolin-specific carrier loadings above 70% w/w in medicated premixes is limited; validation should be conducted with the specific mixer geometry and active substance dust characteristics.
Topical kaolin powders are formulated as dry absorbent dressings and umbilical cord dusting powders for cattle, horses, and sheep; the formulation addition ratio of kaolin ranges from 40–80% w/w, with the balance consisting of zinc oxide, sulfur, or starch-based diluents where approved. The downstream production process begins with 150 μm sifting and V-shell blending for 20–40 min at 15–25 rpm; overblending above 60 min pulverizes the platelets and raises fines below 10 μm, which increases inhalation risk for operators and reduces adherence to moist wound surfaces. Terminal finished product types include dusting powder bottles with shaker caps, squeeze-puff applicators for umbilical cords, and dry wound spray devices using compressed air or pump dispersing mechanisms.
Industry compliance for marketed veterinary topical preparations follows EU Regulation 2019/6 and 21 CFR 211 for drug products, with microbial limits per Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13 and elemental impurity screening per ICH Q3D; terminal sterilization is not typical, so bioburden control at milling and filling is critical. The formulation addition ratio below 40% w/w kaolin reduces absorbent capacity to clinically irrelevant levels, while above 80% w/w the powder becomes too cohesive to pass uniformly through a shaker orifice of 2–4 mm. Field use on deep puncture wounds, oozing purulent tracts, or body cavities is contraindicated because kaolin powder can form occlusive clumps and delay surgical debridement.
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Kaolinum Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a purified hydrated aluminium silicate of kaolinite mineralogy, supplied under a veterinary-dedicated release programme. Representative supplier model codes are KVM-75T, KVM-12I and KVM-45P; the suffixes denote the intended processing class rather than a difference in mineral species. The core chemical specification for all models is aluminium oxide 38.0–46.0% w/w, silicon dioxide 44.0–52.0% w/w, iron oxide not more than 1.0% w/w, and loss on ignition 12.0–15.0% w/w. Identification is performed by X-ray diffraction with Cu Kα radiation at 40 kV/40 mA; the kaolinite basal reflection at 7.2 Å must be present without detectable chlorite interference. The API is insoluble in water and does not form a true solution; the label phrase Solutions refers to ready-to-use aqueous or oily suspensions compounded by the downstream manufacturer. The product is released against USP <61>, USP <62>, Ph. Eur. 2.4.8, and USP <232>/<233> methods, with lot-specific certificates of analysis.
Industrial kaolin entering refractory, paper, or paint production is typically supplied without microbial enumeration and with broad particle-size spans that are acceptable for viscosity control but unsuitable for oral or parenteral dosage forms. Veterinary-grade release adds a compendial-leaning acceptance matrix. Total aerobic microbial count is controlled according to USP <61>; specified organisms are tested according to USP <62>. Elemental impurity limits follow USP <232>/<233> categories appropriate for the intended route of administration. For oral and premix models, total heavy metals are limited to ≤20 ppm; for the injectable model, the limit is ≤10 ppm. Arsenic is limited to ≤2 ppm because groundwater sourcing presents a risk of geogenic contamination. The finished API is dried to a loss on drying value of ≤1.0% for oral and injectable models and ≤1.5% for the premix model. Bulk density is controlled because feed mills and tablet presses use volumetric feeding; a drift outside 0.45–0.65 g/cm³ indicates moisture uptake or improper milling. The customer receives a certificate of analysis with actual batch values and the test method designations.
| Model | Laser diffraction D50 | Laser diffraction D90 | Bulk density | Loss on drying | Total heavy metals | Endotoxin |
|---|---|---|---|---|---|---|
| KVM-75T | 8–12 µm | ≤45 µm | 0.45–0.60 g/cm³ | ≤1.0% | ≤20 ppm | <50 EU/g |
| KVM-12I | 2–4 µm | ≤10 µm | 0.30–0.45 g/cm³ | ≤1.0% | ≤10 ppm | ≤0.5 EU/g |
| KVM-45P | 15–25 µm | ≤75 µm | 0.50–0.65 g/cm³ | ≤1.5% | ≤20 ppm | <100 EU/g |
These values are representative of supplier technical bulletins and are not compendial acceptance criteria; the certificate of analysis controls each batch.
Direct compression of KVM-75T at 10–30% w/w in tablet matrices requires pre-drying at 105°C to LOD ≤1.0% when ambient relative humidity exceeds 60%. The powder has a true density of 2.6 g/cm³; the tapped bulk density falls between 0.45 g/cm³ and 0.60 g/cm³ for the tablet model. Flow function coefficient measured by ASTM D6128-16 in a Schulze ring shear tester is generally below 4 without glidant, indicating cohesive flow; addition of 0.5% w/w colloidal silicon dioxide raises the flow function coefficient above 6 and reduces hopper arching. In a high-shear granulator operated at impeller 300 rpm and chopper 1500 rpm, purified water demand for KVM-75T is 25–35% w/w; endpoint is determined by the power consumption curve, not visual appearance. Slugging and roller compaction are used for dry granulation because kaolin compacts by particle rearrangement and plastic deformation without requiring binder. Capsule fills at 10–20% w/w of KVM-75T provide anti-adherent properties, but the product must be sieved through a 0.850 mm screen before blending to remove agglomerates. Tablet friability and disintegration are formulation-dependent; published data for this specific configuration is limited. For powders and granules, KVM-45P is dry-blended with excipients in a V-blender at 15 rpm for 15 minutes; over-blending beyond 30 minutes can generate fine particles by attrition.
KVM-12I is processed to a laser-diffraction D50 of 2–4 µm and D90 ≤10 µm according to ISO 13320. The wet cake is refined in a sanitary classifier, washed twice with water for injection, and dried in an ISO 14644-1 Class 8 cleanroom before terminal sterilization. Moist-heat sterilization at 121°C for 15 minutes with a validated F0 ≥8 does not collapse the kaolinite platelet because the dehydroxylation threshold is above 450°C. The injectable grade is not intended for intravenous administration; final particulate matter is assessed according to USP <788>, and the suspension must be syringeable through a 21G thin-wall needle at 25°C with a force not exceeding 5 N. Endotoxin content is limited to ≤0.5 EU/g by LAL assay following Ph. Eur. 2.6.14. Aseptic filling is used when the final container cannot withstand terminal steam sterilization; in that case, the API is pre-sterilized by moist heat and mixed with a sterile vehicle under laminar flow. Sterile filtration of the final suspension is not used because the particles are retained by a 0.2 µm membrane. Batch-to-batch variation in D50 is controlled within ±0.5 µm for KVM-12I because suspension viscosity and sedimentation rate are sensitive to particle size. A shift from D50 3 µm to 5 µm can increase sedimentation rate by a factor of 2–3 according to Stokes settling; therefore the injectable model is not interchangeable with the oral model.
Liquid oral preparations labelled as Solutions are suspensions with a continuous aqueous phase. KVM-75T is dispersed at 5–20% w/v in purified water containing 0.2–0.5% w/v sodium carboxymethyl cellulose. The suspension is passed through a rotor-stator mixer at 5000 rpm for 5 minutes to break agglomerates; a vacuum of −0.8 bar is applied to remove entrained air. Sedimentation volume after 24 hours is maintained at 0.90 or higher by rheological adjustment, not by increasing kaolin concentration above 20% w/v, because higher concentrations produce pseudoplastic viscosity that impedes pouring. The vehicle pH is kept between 5.0 and 7.0; below 4.0, aluminium release increases. Preservative compatibility should be confirmed because benzalkonium chloride adsorbs onto kaolin at 0.02% w/v, reducing free concentration; preservative efficacy testing according to Ph. Eur. 5.1.3 is required when preservatives are present. For feed premixes, KVM-45P is added at 0.5–2.0% w/w in a twin-screw continuous mixer with L/D 24:1 at 200 rpm. Addition is made after calcium carbonate and before choline chloride to avoid clumping from moisture transfer. Dust generation is controlled by the D90 ≤75 µm specification; extraction air velocity across the weigh belt of 0.7 m/s is sufficient for this particle size. Mycotoxin binding is not inferred from total surface area alone; adsorption isotherm data for aflatoxin B1 are reported in supplier technical bulletins, while published data for deoxynivalenol and zearalenone are limited.
Thermal exposure above 550°C converts kaolinite to metakaolin, an amorphous aluminosilicate with increased surface area but altered adsorption selectivity. For oral adsorbent applications, this conversion is not required because the native kaolinite platelet already provides hydrogen-bonding and van der Waals adsorption of low-molecular-weight polar toxins. Thermogravimetric analysis shows the principal dehydroxylation mass loss between 450°C and 600°C; the cumulative loss of 12.0–15.0% w/w corresponds to structural hydroxyl groups. Processing above 850°C initiates spinel formation and should be avoided because the resulting hard agglomerates increase tablet punch wear and reduce suspension redispersibility. For terminal sterilization of injectable grade, moist heat at 121°C is preferred over dry heat above 300°C because dry heat can deactivate surface adsorption sites and cause interparticle bonding. The supplier thermal processing window for KVM-75T and KVM-45P is therefore limited to 250°C for 2 hours; this step reduces vegetative bioburden without converting the mineral phase.
Kaolinum differs from bentonite primarily in cation exchange capacity and swelling. The kaolinite structure is a 1:1 tetrahedral-octahedral sheet with no interlayer water and a basal spacing of 7.2 Å. Cation exchange capacity is 5–15 meq/100 g, compared with 70–120 meq/100 g for bentonite and 20–40 meq/100 g for attapulgite. Brunauer-Emmett-Teller surface area is 10–20 m²/g, compared with 600–800 m²/g for bentonite, 120–180 m²/g for attapulgite, and 500–1500 m²/g for activated charcoal. The lower cation exchange capacity of kaolinite reduces aggressive binding of some weakly basic veterinary drugs but does not eliminate the interaction; oral antimicrobials should be separated by at least 2 hours from kaolin administration. Swelling capacity is <5 vol% after 24 hours, while bentonite can swell beyond 200 vol% and attapulgite below 50 vol%. This low swelling makes kaolin suitable for tablet matrices and premixes where smectite clay expansion would cause tablet splitting or pellet die blocking. Activated charcoal has broader adsorption but lacks the crystalline platelet structure and white-to-cream appearance of kaolinite.
| Property | Kaolinum | Bentonite | Attapulgite | Activated charcoal |
|---|---|---|---|---|
| Cation exchange capacity | 5–15 meq/100 g | 70–120 meq/100 g | 20–40 meq/100 g | Not applicable |
| BET surface area | 10–20 m²/g | 600–800 m²/g | 120–180 m²/g | 500–1500 m²/g |
| Swelling capacity | <5 vol% | >200 vol% | <50 vol% | Not applicable |
| Basal spacing | 7.2 Å | 12–15 Å | 10.5 Å | Not applicable |
Acid activation is not used for Kaolinum because the veterinary grade relies on the native kaolinite surface. Acid-activated bentonite and some attapulgite grades can exhibit residual acid, requiring neutralisation; Kaolinum avoids this step and therefore has a pH of 4.0–7.0 when dispersed at 10% w/v in water according to ISO 787-9. Residual sulfate is below 0.1% w/w. This difference reduces the risk of acid-catalysed hydrolysis in moisture-sensitive formulations and avoids the extra neutralisation step required for acid-activated clays.
On a feed-mill line, KVM-45P is dosed at 0.8% w/w into a broiler premix through a loss-in-weight feeder calibrated to ±1% accuracy. The addition point is after calcium carbonate and before choline chloride; this placement minimises moisture transfer and preserves flow. The premix is pelleted through a ring die at 70–80°C; kaolinite platelets remain stable under these conditions because the temperature is far below the dehydroxylation threshold. After pelleting, pellet durability is assessed by a Holmen durability tester; the effect of kaolin on pellet hardness is formulation-specific. No additional processing additive is required for this application.
