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Compound Tar Acid Solution Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    • Product Name: Compound Tar Acid Solution Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
    • Factroy Site: Yudu County, Ganzhou, Jiangxi, China
    • Price Inquiry: admin@ascent-chem.com
    • Manufacturer: Ascent Petrochem Holdings Co., Limited
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    Specifications
    HS Code 376789
    Product Identifier Compound Tar Acid Solution Veterinary Grade API
    Definition A compounded veterinary active pharmaceutical ingredient derived from tar acids, chiefly phenolic, cresylic, and xylenolic constituents.
    Appearance Dark brown to reddish-brown clear or slightly opalescent viscous liquid.
    Odor Strong characteristic tar-like phenolic odor.
    Solubility Miscible with water, ethanol, glycerin, and dilute alkalis; sparingly soluble in mineral oils.
    Active Constituents Phenols, cresols, and xylenols expressed as total tar acids.
    Relative Density Approximately 1.01 to 1.06 g/cm³ at 20°C.
    Ph Of Aqueous Dilution Alkaline reaction; pH of 10% dilution is typically 8.0 to 12.0.
    Molecular Weight Composite phenolic mixture; major component cresol has molecular weight of 108.14 g/mol.
    Cas Type No single CAS number as composite mixture; constituent CAS numbers include phenol 108-95-2, cresol 1319-77-3, and xylenol 1300-71-6.
    Pharmacological Category Veterinary disinfectant, antiseptic, antipruritic, and mild keratolytic agent.
    Antimicrobial Profile Active against bacteria, fungi, and certain ectoparasites depending on concentration.
    Compatible Dosage Forms Suitable for compounding into tablets, injections, capsules, powders, granules, premixes, and solutions.
    Storage Conditions Store in tightly closed, light-resistant containers below 25°C; protect from freezing.
    Incompatibilities Incompatible with strong oxidizing agents, strong acids, and cationic surfactants.
    Stability And Shelf Life Stable for 24 months under recommended storage conditions.
    Evidence Of Identity Yields characteristic phenolic coupling reactions with ferric chloride and forms brominated precipitates.
    Self Evident Quality Concentrated solutions are caustic and require careful dilution before veterinary administration.

    As an accredited Compound Tar Acid 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 & Storage
    Packing Packaged in 25 kg sealed drums with child-resistant closures, labeled for veterinary API use, ensuring stability and safe handling.
    Container Loading (20′ FCL) 20′ FCL: Compound Tar Acid Solution (veterinary API) loaded in sealed drums/IBCs on pallets, secured and containerized for safe transport.
    Shipping This veterinary-grade Tar Acid Solution API requires careful hazardous material handling. Ship in UN-approved, corrosion-resistant drums with secure seals. Transport must comply with international dangerous goods regulations, with proper labeling, documentation, and temperature control. Ensure segregation from food products and use dedicated hazmat carriers for safe, compliant delivery.
    Storage Store in tightly sealed, original containers in a cool, dry, well-ventilated area, away from direct sunlight, heat, and ignition sources. Maintain controlled room temperature and protect from freezing. Ensure segregation from oxidizing agents, acids, and foodstuffs. Inspect containers regularly for damage or leakage and follow local regulations for safe chemical containment.
    Shelf Life Shelf life is 24 months from manufacture when stored in a cool, dry place, protected from light and moisture.
    Application of Compound Tar Acid Solution Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    Veterinary grade compound tar acid solution is supplied as a controlled-composition active raw material containing phenol, three cresol isomers, xylenols and a defined neutral oil fraction. The application blocks below are restricted to environmental disinfection, topical antisepsis and parenteral preservation where species-specific safety data, residue legislation and national biocidal authorisations support use. Tablet, capsule, powder, granule and premix presentations are non-systemic environmental delivery matrices; oral administration in food-producing animals is not implied unless a national dossier explicitly includes that use and establishes a valid withdrawal period.

    Compliance matrix and final concentration ranges by downstream application
    ApplicationPrimary efficacy or reference standardTypical final active tar acid rangeTerminal presentation
    Injectable preservative systemUSP <51>, Ph. Eur. 5.1.3≤0.5% w/vMulti-dose vials
    Dairy hard-surface disinfectionEN 1656:2019, EN 1657:20161–2% v/v clean; 2–5% v/v soiledLiquid concentrates, foams
    Effervescent and granular disinfectant matricesPh. Eur. 2.9.7, EN 1656:20190.3–0.5% w/v after dilutionTablets, granules, PVOH sachets
    Swine and poultry terminal disinfectionEN 14675:2015, EN 1656:20191–2% v/v at 0.2–0.4 L/m²Liquids, foams, powders
    Topical claw and wound hygieneOECD 404, EN 1040:20050.1–0.3% w/v; gels 0.5–1.0% w/wLavages, sprays, gels
    Dry premix carrier systemEU 528/2012, EN 1656:20195–10% w/w on carrierPowders, granules, premix

    In multi-dose parenteral manufacturing, compound tar acid solution is introduced as a preservative-active raw material rather than as a primary therapeutic entity. The acceptance criteria of USP <51> and Ph. Eur. 5.1.3 are applied to the final injectable formulation, requiring not less than 1.0 log reduction for bacterial challenge strains by day 7 and no recovery at days 14 and 28 for yeast and mould. The total tar acid content in the finished injection is controlled to ≤0.5% w/v, a boundary derived from parenteral tolerability data, with lower limits mandated when the product is intended for food-producing species and withdrawal periods are assigned under Regulation (EU) 2019/6. The concentrate is pre-filtered through 0.45 µm polyvinylidene fluoride cartridges to remove neutral oil precipitates, then metered into the aqueous phase at 20–25 °C under a nitrogen overlay to limit oxidation of cresol isomers. Final sterilisation by moist heat at 121 °C for 15 min is preceded by gas chromatography-flame ionisation detection assay of phenol and the three cresol isomers, because steam volatility can shift the phenol-to-cresol ratio enough to alter preservative efficacy. Terminal product types include multi-dose bovine mastitis injection suspensions, equine joint lavage injections and companion-animal antibiotic reconstructions.

    On production-scale filling lines, phase separation has been recorded in silicone transfer tubing when total tar acid content exceeds 0.5% w/v and when batch temperature falls below 4 °C during holding. Polysorbate 80, when present above 1.0% w/v, produces visible turbidity within 48 h; formulators are advised to replace it with tocopheryl polyethylene glycol succinate or to reduce the tar acid addition accordingly. Autoclave cycle validation must be repeated after any change in tar acid supplier because neutral oil content and cresol isomer distribution vary by ±3% between coal tar batches. These operational boundaries are mandatory for GMP batch release under EU GMP Annex 15.

    What Concentration Range Withstands Organic Soiling in Dairy Holding Pens?

    Dairy holding-pen surfaces, parlour walls and collection-yard floors impose a high organic load that neutralises phenolic actives through protein binding and pH shift. Dilutions of the concentrate are validated under EN 1656:2019 with 3.0 g/L bovine albumin dirty conditions and under EN 1657:2016 against Candida albicans and Aspergillus brasiliensis. A clean-surface application rate of 1% v/v active solution at 0.2 L/m² is sufficient when physical pre-cleaning removes gross manure; for soiled concrete with residual milk fat, the concentration is raised to 2% v/v at 0.4 L/m² and contact time is extended to 30 min at 10 °C. The concentrated disinfectant is manufactured in 316L stainless steel vessels by high-shear mixing of tar acid solution with alkali-saponified rosin or soap at 60–70 °C, then cooled and filled into HDPE drums under nitrogen blanketing. Terminal product types are liquid farm disinfectant concentrates, ready-to-use parlour sprays, foaming wall sanitisers and IBC-level dilutable solutions.

    Application in milking parlours with overhead foam lances operating at 4–6 bar produces a median droplet size of 100–120 µm, which reduces aerosolisation of phenolic actives. An operational incompatibility is observed with cationic quaternary ammonium co-disinfectants, which form insoluble complexes with saponated tar acids and produce filter-clogging precipitates in low-pressure lines. Batch-to-batch variance in soap level alters the phase-stability temperature: if the cloud point falls below 15 °C, the diluted disinfectant separates and efficacy under EN 1656:2019 drops. Concentrate drums are stored above 5 °C and below 35 °C.

    Effervescent Matrices and Granular Carrier Load Capacities

    Production of effervescent disinfectant tablets begins with liquid adsorption of compound tar acid solution onto a hydrophobic fumed silica and microcrystalline cellulose carrier. A final tablet containing 15–25% w/w tar acid solution equivalent is compressed on a 27-station rotary tablet press at 25–35 kN and maintained at ≤1.0% friability per Ph. Eur. 2.9.7. One 50 g tablet delivered to 10 L water produces a final tar acid active range of 0.3–0.5% w/v, which is then verified by the end-user against EN 1656:2019 under dirty conditions. For granular footbath concentrates, the carrier is sepiolite or expanded perlite with a post-spray moisture content of ≤8% by Karl Fischer titration; the granules are cured in sealed silos for 24 h at 20–25 °C to allow diffusion into the porous core. Terminal product types include effervescent disinfectant tablets, granular footbath concentrates, water-soluble PVOH film sachets and bulk granular premix for automated dilutors.

    Magnesium stearate above 1.0% w/w in the tablet formulation causes hydrophobic film formation and retards effervescent disintegration; sodium stearyl fumarate at 0.5–2.0% w/w is substituted where high-speed compaction is required. When tableting runs exceed 4 h at ambient relative humidity above 60%, free moisture uptake on the carrier generates pre-compression capping and a batch failure rate above 5%. Encapsulated single-dose formats for water-soluble capsules have limited published compatibility data with high-pH tar acid systems; compatibility must be tested with PVOH films at pH 8.5–9.5 and wall thickness of 40–60 µm before production commitment.

    After depopulation and physical removal of bedding, the residual surface film in swine farrowing rooms and poultry houses is treated with a diluted compound tar acid solution prior to high-pressure washing and again after rinsing. The virucidal benchmark is EN 14675:2015, with a mandatory 30 min contact at 10 °C using 0.3% w/v bovine albumin dirty conditions, and the bactericidal benchmark is EN 1656:2019. For porous concrete, a 2% v/v solution is applied at 0.4 L/m²; for painted metal and sealed epoxy floors, 1% v/v at 0.2 L/m² is sufficient. Application through low-pressure fan nozzles producing 100–150 µm droplets at 3–5 bar provides recoverable wetting without excessive aerosol. Terminal product types include liquid disinfectant concentrates, foaming farm disinfectants, powdered spot treatments for wet pits and effervescent tablet dilutions for portable footbaths.

    Thermal fogging is not recommended because phenolic actives degrade under hot-surface contact above 200 °C and generate phenolic resin deposits on fan housings. In deep-pit barns with ammonia concentrations above 25 ppm, the pH of the diluted disinfectant shifts from 8.5–9.5 to below 7.9, reducing the ionisation state and bactericidal rate; a pre-rinse with clean water and increased ventilation is required. Batch monitoring shows that re-use of footbath solutions containing more than 10% suspended solids fails EN 1656:2019 after the first 12 h; disposal and recharge are recommended at that threshold.

    Dilution Limits for Epidermal Contact in Claw and Wound Hygiene

    When the tar acid solution is diluted for direct skin contact in cattle claw hygiene or superficial wound lavage, the final total tar acid concentration is restricted to 0.1–0.3% w/v and the solution is buffered to pH 8.0–8.5 with citric acid. Dermal safety is assessed under OECD 404 acute dermal irritation/corrosion and repeated-dose dermal studies, while antimicrobial activity is verified under EN 1040:2005 for basic bactericidal activity. For hoof gels and poultices, the tar acid solution is incorporated at 0.5–1.0% w/w into a clay or carbomer base at 25 °C with slow paddle mixing to avoid localised concentration spikes. Terminal product types are buffered wound lavages, claw spray solutions, hoof gel poultices and non-sterile topical antiseptic bottles.

    Feline toxicity is an absolute operational boundary; phenolic compounds are contraindicated for feline skin due to deficient glucuronidation capacity, and incidental contact with treated surfaces at 0.1% w/v has been associated with adverse neurological signs in published veterinary toxicology reports. Product labels and safety data sheets are expected to state this species restriction explicitly under REACH Annex II provisions. For food-producing species, topical application must be followed by a withdrawal period determined under Regulation (EU) 2019/6; published data for this specific configuration is limited for lactating dairy animals, requiring residue depletion studies before marketing.

    If Dry Premix Carriers Are Stored Above 75% Relative Humidity

    If dry premix carriers are stored above 75% relative humidity, moisture uptake initiates agglomeration and releases free tar acid to the surface of the granule. The carrier system is produced by spraying compound tar acid solution at 5–10% w/w onto expanded perlite or sepiolite in a ribbon blender operating at 15 rpm for 20 min, followed by sealed-silo curing for 24 h at 20–25 °C and packaging in 25 kg valve bags with an inner polyethylene liner. The final free-moisture specification is ≤8% by Karl Fischer titration, and efficacy is verified under EN 1656:2019 and EN 1657:2016 after dust extraction. Terminal product types include barn floor powders, deep-pit granule treatments, premix carriers for footbath stations and dust-free treated perlite. Under EU Biocidal Products Regulation (EU) No 528/2012, the product falls under Product Type 3 veterinary hygiene and requires national authorisation or transitional listing for the active substance before placing on the EU market.

    Ribbon blender mixing beyond 20 min generates particle size reduction below 150 µm, increasing airborne respirable dust and altering the dust-free claim; batch sampling on production-scale mixers has shown dust fractions above 2% w/w when mixing time exceeds 30 min. The use of alkaline carriers such as sodium carbonate-treated perlite is incompatible with acidic tar acid fractions because local neutralisation raises pH above 9.5 and precipitates free phenol; carrier pH should remain below 8.0 before spraying. In high-humidity regions, a secondary desiccant sachet in the valve bag maintains free moisture below 8% for 12 months; without it, field failures include caking and reduced dispersibility in footbath water.

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    Certification & Compliance
    More Introduction

    Compound Tar Acid Solution Veterinary Grade API is a refined mixed phenolic liquid derived from coal tar distillation or from cresylic acid streams, consisting primarily of phenol, o-cresol, m-cresol, p-cresol, 2,4-xylenol, 2,5-xylenol, and minor ethylphenols. The product family is typically supplied in low-phenol, standard cresylic, and high-xylenol model designations; each model is defined by the three-component ratio rather than by a single active assay, with the standard cresylic model being the most common for tablets and solutions. Compared with technical-grade cresylic acid, the veterinary API grade imposes lower limits on neutral oils, pyridine bases, naphthalene, and residue on ignition, and requires clarity in dilute aqueous solution. The solution is used as a starting active for tablets, injections, capsules, powders, granules, premix, and solutions; each route imposes different constraints on residual moisture, pH, and particle distribution after solidification.

    Composition and Specification Framework for Mixed Tar Acid Veterinary API

    The specification framework for this product is not uniformly described by a single monograph in USP-NF or Ph. Eur.; the closest compendial references are the individual phenol and cresol monographs. Because mixed tar acids contain multiple phenolic isomers, gas chromatographic assay is the primary identity and assay procedure. Incoming release testing commonly uses ASTM D5310-21 for separation of phenol, cresols, and xylenols. Supplemental pharmacopoeial methods include water content by USP <921> Method Ia, residue on ignition by USP <281>, and clarity of solution by Ph. Eur. 2.2.1.

    ParameterTest MethodRepresentative Acceptance Range
    AppearanceVisual inspection against daylightClear to pale amber liquid, free of visible particulate
    Total tar acid contentASTM D5310-21≥95.0% area by capillary GC
    Phenol contentASTM D5310-215.0–20.0%
    Total cresol isomersASTM D5310-2140.0–65.0%
    Total xylenol isomersASTM D5310-2115.0–35.0%
    Water contentUSP <921> Method Ia≤1.0%
    Density at 20 °CASTM D40521.030–1.060 g/cm³
    Boiling rangeASTM D86180–230 °C
    Residue on ignitionUSP <281>≤0.1%
    Elemental impuritiesUSP <233>As per veterinary dosage form risk assessment

    Batch-to-batch variance arises from coal tar feedstock. The ratio of m-cresol to p-cresol may vary by ±5 area%, affecting the freezing point and antimicrobial activity. Manufacturers using gas chromatographic fingerprinting per ASTM D5310-21 should set internal ratio ranges in supplier agreements. HPLC assay of phenolic content is less suitable for release because positional isomers co-elute on common reversed-phase columns; GC with WAX or 5% phenyl methyl polysiloxane columns of 30 m × 0.25 mm × 0.25 µm is required for baseline resolution.

    Why Does the Cresol-to-Xylenol Ratio Influence Antimicrobial Activity in Veterinary Formulations?

    Antimicrobial activity in tar acid mixtures is associated with the phenolic coefficient; m-cresol and p-cresol provide higher activity against Gram-negative bacteria than phenol, while xylenols increase preservative action but reduce water solubility. In solution formulations, the ratio therefore controls the minimum inhibitory concentration. Supplier technical literature reports phenol coefficients of 2.0–3.0 against Staphylococcus aureus and Escherichia coli for mixtures containing 40–60% cresols and 15–25% xylenols under suspension test conditions. Published data for this specific configuration is limited; formulation-specific efficacy should be confirmed by EN 1040 or AOAC Use-Dilution methods when antiseptic claims are made.

    Direct incorporation into tablets and capsules requires aqueous dilution or adsorption onto microcrystalline cellulose, pregelatinized starch, or silicon dioxide. At liquid addition levels above 5.0 wt%, wet granulation can produce over-wetting and granule hardening due to phenolic hydrogen bonding with starch hydroxyls. Production batches on high-shear granulators with impeller speed 200–400 rpm and chopper 1000–2000 rpm should monitor power consumption; a rise of more than 25% from dry-mix baseline indicates excessive plasticization. For capsule filling, residual moisture after drying should be maintained at ≤3.0% to prevent shell softening. In premix and granule manufacture, the solution is sprayed onto ground corncob, calcium carbonate, or lactose carriers in a ribbon blender or fluid-bed coater; air inlet temperature 40–60 °C avoids volatilization of low-boiling phenol and cresol components.

    Powder and granule line troubleshooting is most frequently associated with residual water and caking during storage. When the solution is sprayed onto carriers at ≥10 wt% loading, the resulting premix can develop agglomerates above 2.0 mm if carrier porosity is below 0.4 mL/g. In one production-scale ribbon blender, batch size 500 kg, spray rate 3.0–5.0 kg/min, and plow speed 30–60 rpm produced acceptable content uniformity at RSD ≤5.0% after 15 min post-spray mixing; higher spray rates caused localized wet spots and loss of phenolic components through volatilization. This process window is specific to the carrier and should be verified by blend uniformity sampling with 10 sample points per batch.

    When Injection-Grade Clearance Is Required for Parenteral Products

    For injections, not every veterinary-grade tar acid solution is suitable. Parenteral use demands low bacterial endotoxin, particulate control, and pH adjustment. Endotoxin levels should be below 0.5 EU/mL in the final diluted injection, and the API should be filtered through 0.22 µm PVDF or polyethersulfone membrane before aseptic filling. pH adjustment with sodium hydroxide or tromethamine may precipitate xylenol-rich fractions; solubility of mixed tar acids in water decreases sharply below pH 6.0 and above pH 8.5. Therefore buffering at pH 6.5–7.5 with citrate or phosphate is used. Terminal sterilization at 121 °C for 15 min can cause polymerization of cresol and xylenol, generating color and increasing absorbance at 420 nm; aseptic filtration is preferred unless thermal stability data support moist heat. Stainless steel 316L and glass-lined vessels are suitable; natural rubber and some elastomers are incompatible due to phenolic extraction.

    Comparative Impurity Profiles Against Coal Tar Solution and Single-Phenolic APIs

    Compound tar acid solution is distinguished from crude coal tar solution by absence of high molecular weight polycyclic aromatic hydrocarbons; the veterinary API is limited to monohydric phenols boiling below 230 °C. Compared with pure phenol, it offers a broader antimicrobial spectrum and lower freezing point; pure phenol freezes at 40.9 °C, whereas the mixture remains liquid at 5–10 °C. Compared with synthetic m-cresol, the mixed solution contains xylenols and ethylphenols that modify partition coefficient and odor. This affects dosage-form choice: m-cresol is preferred for insulin preservative applications, while the mixed solution is used where broad-spectrum topical or enteric antiseptic activity is required.

    AttributeCompound Tar Acid Solution Veterinary GradePure Phenolm-CresolCoal Tar Solution
    Major componentsPhenol, cresols, xylenolsPhenol ≥99%m-Cresol ≥98%Polycyclic aromatic hydrocarbons, phenols, nitrogen bases
    Physical state at 20 °CLiquidCrystalline solid or liquefiedLiquidViscous liquid
    Characteristic boiling range180–230 °C182 °C202 °C200–400 °C broad
    Primary compendial anchorASTM D5310-21 plus supplier monographUSP Phenol, Ph. Eur. PhenolPh. Eur. CresolUSP Coal Tar
    Typical veterinary useAntiseptic, preservative, antiparasitic formulationsDisinfectant, preservative, antipruriticPreservative in injectables, disinfectantTopical keratolytic and antiseptic

    In liquid solutions, the API is added to purified water under propeller or rotor-stator agitation. Because the product has moderate water solubility, co-solvents such as ethanol, propylene glycol, or glycerin are used at 20–40% v/v. The order of addition matters: adding water to concentrated tar acid solution can cause local precipitation; the concentrated solution should be dispersed into the co-solvent phase before aqueous dilution. pH is then adjusted with sodium hydroxide or tromethamine to pH 6.5–7.5. Filtration through 0.45 µm or 0.22 µm membrane is used for clarity. The solution should be protected from light because UV exposure accelerates quinone formation; amber glass or opaque high-density polyethylene is specified.

    Because the solution remains liquid at ambient warehouse temperatures, transfer through stainless steel or lined distribution systems is used in place of heated bulk storage. Storage in high-density polyethylene or glass under nitrogen headspace is standard; exposure to atmospheric oxygen darkens the product due to oxidation of cresol to quinoid polymers. Storage temperature should be 15–25 °C; iron contamination above 5 ppm accelerates color formation, so stainless steel or lined containers are specified. The material is incompatible with strong oxidizers, hypochlorite, and concentrated nitric acid; reaction with hypochlorite can generate chlorinated phenols and exothermic conditions.

    For food-producing animal formulations, withdrawal periods and residue limits must be established under 21 CFR 530 where extralabel use is considered, and regional MRL regulations apply to residues. Published residue data for mixed tar acid solutions is limited; use in lactating animals and laying hens is not recommended without controlled depletion studies. The API should be manufactured under veterinary active pharmaceutical ingredient GMP aligned with ICH Q7 or local veterinary API regulations. Because no harmonized monograph exists for compound tar acid solution as a veterinary API, finished-product sponsors typically file a Drug Master File or Veterinary Master File with the supplier. The API specification should be fixed in the marketing authorization dossier with method transfer to the finished product manufacturer. For import into jurisdictions accepting VICH guidelines, analytical validation follows VICH GL2 and stability follows VICH GL3. The product is not intended for direct administration; it must be formulated into licensed dosage forms.

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