| HS Code | 419844 |
| Chemical Name | Tannic Acid |
| Cas Number | 1401-55-4 |
| Molecular Formula | C76H52O46 |
| Molecular Weight | 1701.20 g/mol |
| Appearance | Yellowish-white to tan amorphous powder |
| Solubility | Freely soluble in water, alcohol, and acetone; practically insoluble in benzene, chloroform, and ether |
| Assay | 96.0% to 102.0% on dried basis |
As an accredited Tannic Acid Ointment 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 | Packaging: 25 kg fiber drums with double polyethylene liners, sealed, moisture-proof, and clearly labeled for veterinary API use. |
| Container Loading (20′ FCL) | 20′ FCL container loading: Tannic Acid Ointment veterinary API in sealed drums/cartons, palletized, secured, ventilated, dry, safe for transport. |
| Shipping | Tannic Acid Ointment Veterinary Grade API is shipped in temperature-controlled, moisture-proof, sealed containers to maintain stability. Standard non-hazardous transport applies, with proper labeling, documentation, and tamper-evident packaging. Deliveries avoid extreme heat or humidity and follow GMP/GDP guidelines to ensure product integrity for pharmaceutical compounding and veterinary use. |
| Storage | Store in a tightly sealed, light-resistant container in a cool, dry, well-ventilated area away from moisture, direct sunlight, and heat sources. Keep away from strong oxidizers and incompatible materials. Ensure the container is clearly labeled and secured to prevent contamination or accidental exposure, maintaining product integrity until use. |
| Shelf Life | Shelf life is typically 24 months when stored in airtight, light-resistant containers under cool, dry conditions, ensuring potency and stability. |
In pre-ruminant calf oral rehydration adjuncts, tannic acid of veterinary API grade is incorporated as an astringent to reduce uncontrolled hydro-electrolytic secretion in scour management. The addition ratio is typically 0.4–1.2% w/w of the dry granule mass, with the upper end reserved for formulations that do not contain bismuth subsalicylate or kaolin-pectin colloidal competing surfaces. A water-soluble carrier system comprising dextrose monohydrate, sodium chloride, trisodium citrate dihydrate, and potassium chloride is pre-blended in a 600 L top-drive high-shear granulator at an impeller tip speed of 5–8 m/s. Tannic acid is added during the final 30–45 s of dry mixing to reduce exposure to the subsequent 8–12 min wet massing cycle. Purified water is metered at 1.5–2.0 kg/min through a ported spray nozzle until 2–3 mm granules are formed. Production-scale observation on high-shear lines indicates consistent granulation endpoints are better controlled by amperometric load than by fixed time; a 10–14% rise in impeller load from dry-mix baseline is used as the endpoint. Wet mass is discharged into a fluid-bed dryer and dried at inlet air temperature 55–65 °C to a product temperature not exceeding 40 °C, with final loss on drying between 2.0–3.5%. Dried granules are passed through an 0.8 mm sieve and transferred to a 2,000 L double-cone blender. For tablet-grade material, sodium croscarmellose and magnesium stearate are added and mixed for 8–10 min. Compression is performed on a 27-station rotary press at 12–18 kN main compression, target hardness 60–100 N, friability below 1.0%, and disintegration below 15 min in 37 °C water. Terminal product types are 1 g, 2 g, and 5 g low-density polyethylene/aluminum/polyethylene terephthalate sachets, 250 mg and 500 mg rapidly dispersible scored tablets, and 100 g bulk tubs for farm-level volumetric dosing. Compliance is anchored to 21 CFR 211.110 for in-process blending uniformity, 21 CFR 225 where the product is registered as a medicated feed adjunct, USP <905> for uniformity of dosage units, USP <1216> for tablet friability, and USP <701> for disintegration.
Aseptic processing rather than terminal steam sterilization is preferred because autoclaving at 121 °C for 15 min accelerates gallic acid release and darkens the solution. Tannic acid is included at 0.05–0.2% w/v in a buffered aqueous vehicle containing sodium citrate and citric acid adjusted to pH 3.5–4.5, below the oxidation threshold where quinone polymers precipitate. The solution is prepared in a 316L stainless-steel jacketed compounding vessel at 40–45 °C under an agitator speed of 300–500 rpm, then cooled to 20–25 °C before passage through an 0.45 µm polyethersulfone prefilter and an 0.22 µm PES sterilizing-grade membrane at a maximum differential pressure of 2.0 bar. Membrane capacity is a critical operational boundary: polyphenol adsorption can reduce recovered solute by 5–15% if the first 200–300 mL of filtrate is not recirculated, and published data for tannic acid–specific membrane capacity remains limited. Filterability must therefore be validated per batch, and membrane integrity testing is conducted before and after filtration per ASTM F838-20. Terminal product types are 10 mL pre-sterilized low-density polyethylene intramammary syringes with smooth cannula tips, packed in units of 12 or 24. Compliance follows 21 CFR 211, USP <71> sterility testing, USP <85> bacterial endotoxin testing, and VICH GL18 residual solvent control. Injectable presentations are confined to local instillation; intravascular administration is contraindicated because tannic acid precipitates plasma proteins and is not supported as a systemic parenteral route.
Because equine pastern dermatitis requires sustained contact with exudative skin without systemic absorption, tannic acid is dispersed in a hydrophobic ointment base at 1.0–5.0% w/w, with the lower range applied when zinc oxide is present to avoid excessive particulate load and possible metal-tannate interaction. The API is air-jet milled to a D90 below 50 µm before incorporation to reduce grittiness in topical films. White petrolatum and anhydrous lanolin are melted in a jacketed ointment vessel at 70–75 °C, cooled to 50–55 °C with continuous slow-sweep agitation, and the tannic acid fraction is added through a 150 µm vibratory sieve. Butylated hydroxytoluene at 0.05–0.2% w/w may be incorporated as a lipophilic antioxidant to limit color change associated with oxygen exposure. The semi-solid mass is passed twice through a stainless-steel roller ointment mill with a rear gap of 100 µm and a front gap of 30–50 µm, then deaerated under vacuum at −0.8 bar for 15–20 min. Terminal product types are 15 g and 30 g aluminum tubes with internal epoxy-phenolic lacquer and 50 g and 250 g high-density polyethylene jars. Compliance is governed by USP <795> for nonsterile compounding, 21 CFR 211 for commercial manufacturing, and ISO 13320-1:2020 for particle size distribution by laser diffraction.
| Application | Primary regulatory/compendial anchor | Critical QC test or process limit |
|---|---|---|
| Calf oral anti-diarrheal granules / tablets | 21 CFR 211.110; USP <905>; USP <1216> | Loss on drying 2.0–3.5%; tablet hardness 60–100 N |
| Intramammary infusion solution | 21 CFR 211; USP <71>; USP <85>; ASTM F838-20 | pH 3.5–4.5; membrane differential pressure ≤2.0 bar |
| Equine pastern dermatitis ointment | USP <795>; ISO 13320-1:2020 | D90 <50 µm; ointment mill front gap 30–50 µm |
| Weaned piglet feed premix | 21 CFR 225.1; EU Regulation 1831/2003 | Coefficient of variation <5%; packaging RH 35–40% |
| Companion animal gastric astringent capsules | 21 CFR 211; USP <905>; USP <1174> | Granule bulk density 0.35–0.50 g/cm³; Carr index <25 |
| Poultry drinking water soluble powder | EU Regulation 1831/2003; 21 CFR 225.1 | Solution pH <5.5; hardness <150 mg/L CaCO₃ |
Dry co-grinding of tannic acid with montmorillonite is performed to reduce segregation in low-inclusion gut-health premixes for weaned piglets. The active fraction is adjusted to 250–500 g/t complete feed, equivalent to 0.025–0.050% w/w, while the premix itself is carried on pre-gelatinized wheat flour and calcium carbonate with a micro-doser setting of 50 g per 100 kg final mix. The process begins with a 5 kg micro-ingredient paddle mixer pass: tannic acid is first blended with montmorillonite at a 1:1 ratio for 10–15 min, then this intermediary is added to a 2,000 L twin-shaft paddle mixer with a fill level of 65–70% and mixed for 8 min until the coefficient of variation drops below 5% across ten sampling ports. Because tannic acid is hygroscopic and will cake at storage relative humidity above 60%, terminal packaging is performed in a humidity-controlled room at 35–40% RH and 18–22 °C. If incoming moisture exceeds 5.0%, pre-drying in a fluid bed at 50 °C for 20 min is applied before final blending. Terminal product types are 1 kg, 5 kg, and 20 kg valve-bottom multiwall paper sacks with low-density polyethylene inner liners, or 25 kg drums for feed-mill addition. Compliance is aligned with 21 CFR 225.1 for medicated feed premises, EU Regulation 1831/2003 where the product is registered as a zootechnical feed additive, and 21 CFR 211.110 where the premix is classified as an intermediate. The operational boundary for feed-mill handling is avoidance of prolonged contact with unlined carbon-steel bins, because iron-tannate complexes can form blue-black deposits that reduce assay and compromise mixer cleanability.
Companion animal gastric astringent capsules containing tannic acid are filled after dry granulation to address cohesiveness and dust containment. The capsule composition is 25–50 mg tannic acid per size 3 hard gelatin capsule with microcrystalline cellulose as diluent and 0.5% w/w sodium stearyl fumarate as lubricant. The powder is compacted on a roller compactor at roll force 6–10 kN/cm, roll speed 4–8 rpm, and screen mesh 0.8 mm to produce granules with bulk density 0.35–0.50 g/cm³ and Carr index below 25. Granules are filled on a dosator-type capsule machine at 60,000 capsules/h, with fill weight monitored every 15 min by automatic checkweighing. Residual moisture is held below 5.0% to avoid gelatin cross-linking from any residual aldehyde fraction in the polyphenol raw material. Terminal product types are 10-count and 30-count polyvinyl chloride/aluminum blister cards and 100-count high-density polyethylene bottles with desiccant canister. Compliance is governed by 21 CFR 211, USP <905>, and USP <1174> for powder flow measurement; dissolution testing may be referenced to USP <711> when a discriminatory medium is validated. The main incompatibility is the combination of tannic acid with free iron or ferric salts in the excipient system, which creates intense blue-black discoloration; microcrystalline cellulose with controlled iron content is therefore preferred.
Solution instability is governed by three interrelated variables: final water pH, dissolved hardness ions, and residence time in stock solution. Product formulation uses 0.05–0.20 g/L drinking water after dilution, with a dry soluble powder concentration of 0.1–0.4% w/w tannic acid on anhydrous citric acid, sodium chloride, and low-moisture dextrose carriers. Production dry blending occurs in a 500 L twin-shell blender at 70–80% fill for 15–20 min, with intensive bar activated for the final 5 min. At the farm, the powder is drawn through a venturi eductor into a 316L stainless-steel intermediate tank at 20–25 °C; recirculating product flow of 4 m/s at the bottom drain prevents sedimentation of insoluble tannate complexes. The critical processing boundary is pH: above pH 5.5, oxidative polymerization to quinone derivatives reduces assay recovery by more than 15% within 4 h, and at water hardness above 150 mg/L CaCO₃, calcium tannate precipitation reduces filterability through nipple drinkers. Cleaning-in-place after batch use requires 1% citric acid solution at 60 °C to remove persistent tannate films from tank walls and piping. Terminal product types are 50 g, 100 g, and 1 kg aluminium/polyethylene sachets and 10 kg drums. Compliance is tied to EU Regulation 1831/2003 for feed additive status, 21 CFR 225.1 for premix CGMP, and potable water quality per WHO Guidelines for Drinking-water Quality, 4th edition. Published data for tannic acid–specific recirculation and precipitate recovery in hard water is limited; validation must include worst-case water hardness and pH trials rather than relying only on controlled laboratory vehicles.
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Tannic acid veterinary-grade API, model designation TAV-VG-01, is a hydrolysable gallotannin powder standardized for incorporation into tablets, hard gelatin capsules, powders, granules, feed premixes, oral solutions, and injectable preparations requiring downstream aseptic processing. The material is assigned CAS 1401-55-4 and is characterized as a complex mixture of polygalloylglucose esters with the nominal molecular formula C₇₆H₅₂O₄₆. The grade is not inherently sterile and must not be dispensed as a finished veterinary medicinal product. The designation “ointment” refers to an API specification suitable for semi-solid astringent preparations; the active substance is supplied as a powder for dispersion into oleaginous, polyethylene glycol, or hydrophilic bases.
Tannic acid veterinary-grade API is supplied as a pale yellow to light brown amorphous powder with a typical bulk density of 0.40–0.65 g/cm³ and tapped density of 0.55–0.85 g/cm³. The substance is freely soluble in water, ethanol, glycerol, and acetone, and practically insoluble in chloroform and fixed oils. A 1% aqueous solution typically exhibits a pH of 3.0–5.0. The powder is hygroscopic above 60% relative humidity; containers should be closed immediately after dispensing. If loss on drying exceeds 6.0%, pre-drying under vacuum at 40–60 °C for 4–8 h is used before weighing and blending. These physical properties influence direct-compression behavior and wet-granulation endpoint control because tannic acid can exhibit poor flow and can bind to ferrous contact surfaces.
The principal difference lies not in the basic gallotannin identity but in the release controls applied to the veterinary-grade API. Technical tannic acid fractions used in leather chemistry, ink manufacture, or botanical extraction may contain variable concentrations of free gallic acid, glucose, plant pigments, insoluble cell-wall residues, heavy metals, and pyrogenic microbial constituents. Veterinary-grade TAV-VG-01 is controlled for elemental impurities under ICH Q3D, residual solvents under USP 467 and ICH Q3C, microbial enumeration under USP 61 and USP 62, and bacterial endotoxins under USP 85 or Ph. Eur. 2.6.14. These specifications support multi-route use, although the finished dosage form must still be validated for the intended route of administration.
A production-scale observation from a 500-L ribbon blender indicates that direct addition of unblended tannic acid to mineral premixes can generate dark iron-tannate specks at worn impeller surfaces. A 1:5 lactose or maize starch pre-blend prior to ribbon blending reduces speck formation. Calcium carbonate pre-blends are less suitable because local pH above 6.0 accelerates oxidative darkening. Contact surfaces for solution tanks, mills, and granulators should be 316L stainless steel, glass-lined, or plastic-lined; unprotected iron, copper, and aluminum surfaces are incompatible.
Tablets, capsules, powders, and granules prepared from TAV-VG-01 require specific flow and moisture controls. Direct compression without glidant commonly produces Carr index values above 35, whereas a blend containing 0.5–1.0% fumed silica and 5–10% microcrystalline cellulose, screened through an 850-µm sieve, typically reduces Carr index below 25. Bulk density variation across lots, typically 0.40–0.65 g/cm³, must be accounted for during die filling on rotary tablet presses. In high-shear wet granulation using a 600-L granulator with impeller speed 100–150 rpm and chopper speed 1500–3000 rpm, torque rather than time is the preferred endpoint indicator because tannic acid has high surface area and can over-wet rapidly. Granules are dried in a fluid-bed dryer at inlet air temperature not exceeding 60 °C until loss on drying is ≤ 5.0%, then milled through a 1.0-mm screen. Starch paste binders above 60 °C are not recommended because thermal darkening may occur.
For hard gelatin capsules, the API is blended with lactose monohydrate, croscarmellose sodium, and 0.5% magnesium stearate. Powder and granule sachets for oral administration should be protected against moisture ingress and formulated to maintain pH below 5.0 on reconstitution. Premix formulations intended for feed medication should use a carrier pre-blend and should not be exposed to alkaline feed matrices for extended holding times because tannic acid binds proteins and can reduce available astringent activity.
Injectable use of TAV-VG-01 requires aseptic filtration or terminal sterilization of the formulated solution; the API alone is not sterile. The powder should be dissolved in water for injection at 20–30 °C under low-shear mixing. Filtration through a 0.22-µm polyethersulfone or polyvinylidene fluoride membrane is preferred. Nylon membranes are not recommended because polyphenolic substances may bind to the membrane surface and reduce filter capacity. Stainless steel 316L or glass-lined tanks are acceptable; copper, unlined aluminum, and unpassivated steel are not.
The solution pH should be maintained between 3.0 and 4.5 during compounding. At pH above 6.5, oxidative browning accelerates and the formation of quinone oligomers may increase. Holding times for alkaline or neutralized solutions should be limited unless oxidation is controlled with an appropriate antioxidant and headspace nitrogen. Bacterial endotoxin limits must be calculated from the maximum intended dose, animal body weight, and route of administration; a batch release certificate alone does not guarantee compliance for every injectable formulation. Published toxicology data for injectable tannic acid in veterinary species are limited, and intravenous administration is generally not recommended due to protein binding and potential hepatotoxicity. When injectable use is pursued, the toxicological justification should be reviewed by a qualified veterinarian and formulation scientist.
Drench solutions can be prepared at 1–3% w/v with a preservative system validated for the target container. The solution should be protected from light and stored in amber glass or high-density polyethylene containers. Astringent activity in the gastrointestinal tract depends on contact time with mucosal surfaces; therefore, feed or water withdrawal is generally specified before administration in accordance with the final veterinary regimen.
When the same API is incorporated into an ointment or wet-pack preparation, it should first be dispersed under high shear in a small portion of the base or cosolvent to prevent fish-eye agglomerates. Water-containing ointment bases should be buffered to pH 3.5–4.5. Anhydrous bases are less likely to darken and may be preferred for equipment lines with extended hold times. For semi-solid processing on a planetary mixer, the API is usually passed through a 500-µm screen before addition to minimize specking. Heating above 60 °C is avoided because color darkening and astringency loss may occur.
The following table lists typical batch release parameters for model TAV-VG-01. The acceptance criteria represent the quality agreement used for multi-route veterinary use; compendial monographs and regional submissions remain the final reference.
| Parameter | Reference method | Acceptance criterion | Multi-route purpose |
|---|---|---|---|
| Appearance | Visual inspection | Pale yellow to light brown amorphous powder | Confirms no gross contamination or thermal darkening |
| Loss on drying | USP <731> | ≤ 6.0% | Prevents caking and weight variation in solid dose forms |
| Residue on ignition | USP <281> | ≤ 2.0% | Limits inorganic impurities |
| pH, 1% aqueous solution | Potentiometric | 3.0–5.0 | Supports solution stability and astringent activity |
| Particle size distribution | ISO 13320:2020 laser diffraction | D90 ≤ 150 µm; D50 45–75 µm | Controls blend uniformity and dissolution in drench solutions |
| Bulk density / tapped density | USP <616> | 0.40–0.65 / 0.55–0.85 g/cm³ | Supports capsule filling and tablet die-fill consistency |
| Residual solvents | USP <467> / ICH Q3C | Class 3 solvents not more than 0.5% total | Controls processing solvent burden across dosage forms |
| Elemental impurities | ICH Q3D | Pb ≤ 5 ppm, As ≤ 2 ppm, Cd ≤ 1 ppm, Hg ≤ 1 ppm | Reduces toxic metal intake in food-producing species |
| Microbial enumeration | USP <61> / USP <62> | Total aerobic count ≤ 10² CFU/g; absence of E. coli and Salmonella | Provides low-bioburden input for oral and solution products |
| Bacterial endotoxins | USP <85> / Ph. Eur. 2.6.14 | Calculated per maximum dose; typical release ≤ 2.5 EU/mg | Supports downstream injectable formulation after filtration |
The batch release certificate should also include retention sample identification, manufacturing date, retest date, and confirmation that the material was produced under current good manufacturing practice for veterinary APIs. For sterile finished products, additional testing of the formulated solution is required for filter integrity, container closure integrity, sterility, and bacterial endotoxins after the relevant hold times.
The API must be stored in a tightly closed, light-resistant container below 25 °C and 60% relative humidity. Exposure to high humidity can produce agglomerates and superficial darkening. The material is incompatible with gelatin, albumin, alkaloids, iron salts, copper salts, aluminum salts, strong oxidizing agents, and alkaline buffers. Combination with iron-containing mineral premixes or oxide pigments should be evaluated because iron-tannate precipitates can reduce available tannic acid and form visible specks. In multi-route veterinary manufacture, the API is a controlled input rather than a ready-to-administer product; each finished dosage form must be validated for its specific route, species, dose, and stability requirements.