| HS Code | 942935 |
| Product Name | Chlorhexidine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Chemical Name | 1,1'-hexamethylenebis[5-(4-chlorophenyl)biguanide] |
| Cas Number | 55-56-1 |
| Molecular Formula | C22H30Cl2N10 |
| Molecular Weight | 505.45 g/mol |
| Appearance | White or almost white crystalline powder |
| Odor | Odorless or practically odorless |
| Solubility | Base practically insoluble in water, slightly soluble in alcohol and soluble in dilute acids; acetate and gluconate salts are more water-soluble |
| Melting Point | 132-136 °C for base; salts may vary |
| Pka | 10.3 for the basic biguanide group |
| Storage Conditions | Store in tightly closed containers, protected from light and moisture, at controlled room temperature |
| Stability | Stable under normal storage conditions; avoid excessive heat, strong oxidizing agents, anionic substances and soaps |
| Antimicrobial Spectrum | Broad-spectrum activity against Gram-positive bacteria, Gram-negative bacteria and some fungi; bacterial spores are generally resistant |
| Mechanism Of Action | Cationic binding to microbial cell membranes disrupts membrane integrity and causes leakage of intracellular components |
As an accredited Chlorhexidine 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 | Chlorhexidine Veterinary Grade API is packed in 25 kg sealed drums with tamper-proof liners, ensuring stability, purity, and safe handling for pharmaceutical formulations. |
| Container Loading (20′ FCL) | Chlorhexidine Veterinary Grade API is loaded as sealed drums/pails into a 20-foot FCL, ensuring safe, dry, contaminant-free transport. |
| Shipping | Chlorhexidine Veterinary Grade API is shipped in sealed, inert containers to prevent contamination and moisture ingress. Shipments comply with hazardous materials regulations, with proper labeling and documentation. Temperature-controlled transport is recommended to maintain stability. All consignments include Certificate of Analysis and safety data sheets, ensuring safe handling for pharmaceutical manufacturing. |
| Storage | Store Chlorhexidine Veterinary Grade API in a cool, dry, well-ventilated area at controlled room temperature, protected from light, moisture, and direct sunlight. Keep the container tightly closed and sealed when not in use. Avoid contact with strong oxidizers, acids, and alkaline materials. Ensure storage area is clean, secure, and accessible only to authorized personnel. |
| Shelf Life | Shelf life: 24 months when stored tightly sealed in a cool, dry place, protected from light and moisture. |
Chlorhexidine digluconate is incorporated into oral retention tablets intended for local action in the canine and feline oral cavity after chewing or slow dissolution in the buccal pouch. The active substance is formulated at 0.12% to 0.20% w/w in the finished dosage form, equivalent to 1.2 mg to 2.0 mg chlorhexidine digluconate per 1 g tablet mass; higher concentrations are deliberately avoided because chlorhexidine evokes intense salivation and rejection behaviour in dogs. The production process employs wet granulation with polyvinylpyrrolidone K30 as a binder, followed by compression at 10 kN to 18 kN on a rotary tablet press and non-enteric film coating with hydroxypropyl methylcellulose to delay release until mastication. Granule moisture content is held below 2.0% w/w to avoid hydrolysis of chlorhexidine during storage. Blend uniformity is verified by sampling 10 locations with an acceptance criterion of ≤5% relative standard deviation for chlorhexidine content by HPLC-UV at 255 nm; tablet friability is controlled below 1.0% after 100 revolutions under USP General Chapter <1216>. Compliance is anchored to Ph. Eur. 5.1.4 for microbiological quality of non-sterile preparations and USP General Chapter <61> for microbial enumeration; residual ethylene oxide, if used for raw-material sterilisation, is validated against ISO 10993-7:2008. Finished product types include chewable dental tablets for dogs, oral retention tablets for cats, and veterinarian-dispensed dental hygiene tablets; systemic absorption is not the therapeutic goal because chlorhexidine exhibits poor oral bioavailability, and capsule formats are therefore not utilised for systemic chlorhexidine therapy in veterinary medicine.
Residual efficacy in post-milking teat dips is governed by the chlorhexidine concentration retained on the teat skin after drying, not by the concentration in the concentrate container. Ready-to-use post-milking teat dips are formulated at 0.25% to 1.0% w/w chlorhexidine digluconate; concentrated farm-mix powders are manufactured at 10% w/w active concentration and diluted with potable water to 0.5% before transfer to the teat-dip cup. Water hardness above 300 mg/L CaCO₃ must be controlled with tetrasodium EDTA because chlorhexidine precipitates as insoluble sulfate or carbonate salts under hard-water conditions. The manufacturing route for concentrates uses a stainless-steel vessel equipped with a bottom-mounted high-shear disperger; chlorhexidine gluconate solution is added at 15°C to 25°C, then xanthan gum and glycerol are dispersed under shear until the apparent viscosity reaches 100 mPa·s to 300 mPa·s at 20°C. Terminal filtration through 50 μm mono-filament mesh removes undispersed polymer agglomerates; batch-to-batch viscosity drift is controlled by in-line torque measurement, and a torque decrease during compounding indicates incomplete polymer hydration. Compliance for manufacturing hygiene follows ISO 6887-1:2017; bactericidal activity is evaluated against Staphylococcus aureus ATCC 6538 and Escherichia coli ATCC 10536 using EN 1656:2019 under 0.3% bovine albumin soil. Finished product types include liquid teat dip concentrates, ready-to-use teat dip solutions, and water-soluble powder packs for on-farm dilution.
In biosecurity programs for swine and poultry housing, effervescent chlorhexidine tablets and granular premixes are produced by dry granulation because the API and the sodium bicarbonate/citric acid effervescent pair react prematurely when residual moisture exceeds 0.8% w/w. Chlorhexidine gluconate solution is sprayed onto sodium bicarbonate at 2.0% to 5.0% w/w dry basis in a vacuum tumble blender, followed by blending with citric acid and sodium carbonate in a bin blender for 15 min at 10 rpm. Roller compaction at 50 bar to 80 bar produces granules with a target size of 0.8 mm to 1.4 mm and a pre-compression granule density of 0.9 g/cm³ to 1.1 g/cm³; compression into 5 g tablets is performed at 12 kN to 16 kN in a dehumidified tableting suite maintained at 20°C to 25°C and 20% to 25% relative humidity. Tablet hardness is controlled between 60 N and 80 N, and disintegration is measured under USP General Chapter <701> with an acceptable limit of <180 s. Dissolution of one 5 g tablet in 10 L water yields approximately 0.1% to 0.25% chlorhexidine gluconate, suitable for footbath replenishment; organic soiling in footbaths reduces activity, and replacement intervals should be determined by biological monitoring rather than visual turbidity. Compliance includes EN 1656:2019 for quantitative suspension testing of veterinary disinfectants and ISO 11930:2019 for challenge testing of antiseptic products. Terminal product forms are effervescent tablets, granular sachets, and bulk granular premix for footbath stations and vehicle wheel dips.
Companion animal dermatological formulations are manufactured with chlorhexidine gluconate at 2.0% to 4.0% w/w in shampoos, 0.5% to 2.0% w/w in leave-on sprays, and 0.5% to 1.0% w/w in impregnated wipes. The upper concentration is limited by skin irritation and post-bath residue rather than by raw-material solubility; chlorhexidine gluconate is fully miscible with water but can be inactivated by anionic surfactants if added before neutral pH adjustment. Production on companion animal dermatology lines begins with a cold gel phase of cocamidopropyl betaine and decyl glucoside at 20°C to 25°C, followed by slow addition of chlorhexidine gluconate solution under low shear to avoid foaming. The pH is then adjusted to 5.5 to 6.5 with glucono-delta-lactone, because chlorhexidine activity declines sharply above pH 8.0 and precipitation may occur in hard-water systems above 300 mg/L CaCO₃. Viscosity of the final shampoo is targeted at 4,000 mPa·s to 8,000 mPa·s at 25°C using Brookfield RVT spindle 4 at 20 rpm; stability is evaluated by confirming no more than 0.5% chlorhexidine precipitation after 90 days at 40°C. Compliance is anchored to Ph. Eur. 5.1.3 for preservative efficacy and ISO 11930:2019 for challenge testing; dermatological finished products are assessed for aerobic plate count under USP General Chapter <61>. Terminal product types include medicated shampoos, leave-on skin sprays, and pre-saturated chlorhexidine wipes for localised pyoderma management.
| Downstream format | Typical chlorhexidine concentration | Critical pH or moisture limit | Key compliance anchor |
|---|---|---|---|
| Oral retention tablet | 0.12%–0.20% w/w | Granule moisture <2.0% w/w | Ph. Eur. 5.1.4; USP <61> |
| Teat dip concentrate | 10% w/w concentrate; 0.5% ready-to-use | pH 5.0–6.5; water hardness <300 mg/L CaCO₃ | EN 1656:2019 |
| Effervescent biosecurity tablet | 2.0%–5.0% dry basis; 0.1%–0.25% diluted | RH <25%; residual moisture <0.8% | EN 1656:2019; ISO 11930:2019 |
| Dermatological spray/shampoo | 0.5%–2.0% spray; 2.0%–4.0% shampoo | pH 5.5–6.5 | Ph. Eur. 5.1.3; USP <61> |
| Wound lavage/dusting powder | 0.05%–0.1% lavage; 1.0% powder | pH 6.0–7.0; sterile filtration 0.22 μm | USP <71>; USP <788> |
| Otic cleanser | 0.2%–0.5% w/w | pH <8.0; avoid bicarbonate buffers | Ph. Eur. 5.1.4; USP <61> |
For equine wound irrigation, the upper chlorhexidine concentration is limited by fibroblast cytotoxicity rather than by raw-material solubility. Sterile lavage solutions are prepared at 0.05% to 0.1% w/w chlorhexidine gluconate, while topical dusting powders contain 1.0% w/w chlorhexidine acetate on a maize-starch or kaolin base. Concentrations above 1.0% are avoided in open granulating wounds because in vitro fibroblast inhibition has been reported; published data for this specific configuration is limited, and formulation decisions should be based on target-animal skin irritation studies rather than human wound-care data. Sterile lavage production is performed by cold dissolution at 15°C to 25°C in pharmaceutical-grade water, pH adjustment to 6.0 to 7.0, and terminal sterilising filtration through a 0.22 μm PVDF filter into sterile HDPE or trilaminate pouches. The dusting powder is manufactured by geometric dilution in a V-blender at 15 rpm for 20 min, followed by sifting through a 150 μm screen to control agglomerates. Compliance for sterile solutions requires USP General Chapter <71> sterility testing and USP General Chapter <788> particulate matter limits; residual solvent levels in chlorhexidine acetate are validated against VICH GL18. Terminal product types include sterile wound irrigation solutions, topical dusting powders, and concentrated antiseptic solutions for local lavage, but not systemic injection; the “Injections” descriptor in the API documentation refers strictly to sterile local irrigation solutions, and chlorhexidine is not licensed as a parenteral systemic veterinary drug.
Adjunctive ear cleansing solutions for canine otitis externa are compounded with chlorhexidine digluconate at 0.2% to 0.5% w/w, usually in combination with Tris-EDTA buffer and a non-ionic surfactant. The manufacturing process requires that chlorhexidine be added after adjustment of the Tris-EDTA buffer to pH 7.0 to 7.8; addition before pH adjustment can generate a turbid precipitate when bicarbonate buffers are present, and chlorhexidine activity is markedly reduced above pH 8.0. Solutions are manufactured in small batches under nitrogen blanketing to prevent oxidation of the surfactant and are passed through a 0.45 μm clarifying filter before filling into LDPE dropper bottles. The addition ratio of chlorhexidine is limited to 0.5% w/w because higher concentrations are associated with otic irritation and are not required for bacterial reduction in the presence of Tris-EDTA, which disrupts Gram-negative outer membranes. Compliance is assessed under Ph. Eur. 5.1.4 for non-sterile aqueous preparations and USP General Chapter <61>; preservative efficacy testing follows Ph. Eur. 5.1.3 with Pseudomonas aeruginosa ATCC 9027, Staphylococcus aureus ATCC 6538, Candida albicans ATCC 10231, and Aspergillus brasiliensis ATCC 16404. Terminal finished product types include ear cleansing solutions with drying agents, otic flushing solutions, and combination ear drops intended only for topical cleansing of the external ear canal; chlorhexidine is not suitable for products designed for the middle ear because of ototoxicity of the active substance.
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Chlorhexidine Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is released as three salt-hydrate models: chlorhexidine dihydrochloride monohydrate, chlorhexidine dihydrochloride anhydrous, and chlorhexidine digluconate solution 20% w/v (200 mg/mL). The dihydrochloride forms are white to almost white crystalline powders intended for solid oral and solid topical intermediates. The digluconate is a clear, colourless to pale amber liquid intended for aqueous solutions, teat dips, oral rinses, and dilution-ready premises. The term “veterinary grade” is defined by the documentary standard: the API is produced under veterinary GMP and is released against pharmacopoeial monographs with a certificate of analysis that includes impurity and microbial data. Injection-related use is confined to antimicrobial preservation in approved multi-dose products; chlorhexidine is not a direct parenteral active.
Because the three models release the same chlorhexidine cation after stoichiometric correction, formulators must not substitute one salt for another on an equal-mass basis. The dihydrochloride contains two hydrochloride residues per molecule and the digluconate contains two gluconate residues; failure to correct the counterion mass changes the delivered cation concentration. This is a common source of batch-to-batch variance when a formulation is transferred from a solid oral dosage form to a liquid rinse without adjustment.
Release testing for the veterinary-grade dihydrochloride is performed by HPLC using USP <621> or Ph. Eur. 2.2.29 and is controlled at 98.0% to 101.0% on dried basis. Infrared identification follows Ph. Eur. 2.2.24. Loss on drying by Ph. Eur. 2.2.32 is not more than 1.0%. Sulphated ash is not more than 0.1%. The specified impurity 4-chloroaniline is controlled below the monograph threshold because it is a potential genotoxic degradation product. Total related substances are not more than 1.0% on dried basis. Elemental impurities are assessed under ICH Q3D using USP <232> and <233>. Residual solvents are tested according to USP <467>. Microbial enumeration by Ph. Eur. 2.6.12 and 2.6.13 or USP <61> and <62> requires total aerobic microbial count not more than 10³ CFU/g, total yeast and mold count not more than 10² CFU/g, and absence of Escherichia coli and Salmonella.
| Parameter | Chlorhexidine dihydrochloride monohydrate | Chlorhexidine digluconate solution 20% w/v |
|---|---|---|
| Appearance | White to almost white crystalline powder | Clear, colourless to pale amber liquid |
| Assay | 98.0% to 101.0% dried basis | 19.0% to 21.0% w/v |
| Loss on drying | ≤ 1.0% | Not applicable |
| pH | Not applicable | 5.5–7.0 |
| 4-chloroaniline | Controlled at monograph threshold | Controlled at monograph threshold |
| Elemental impurities | ICH Q3D via USP <232>/<233> | |
| Microbial limits | TAMC ≤ 10³ CFU/g; TYMC ≤ 10² CFU/g; Escherichia coli and Salmonella absent | |
| Residual solvents | USP <467> | |
Particle-size distribution is controlled by laser diffraction per Ph. Eur. 2.9.31 or USP <429>. A typical D50 for dihydrochloride is 50 µm to 150 µm, with D90 not more than 250 µm. This range is selected to balance flowability and blend uniformity; finer material increases electrostatic loss and coarser material retards dissolution in tablets.
During production-scale dry blending of the dihydrochloride, the API is first screened through a 500 µm sieve and premixed with an equal portion of microcrystalline cellulose for 10 min in a twin-shell blender operating at 20 rpm. This step reduces agglomerates and improves content uniformity in tablets and capsules. Electrostatic charging is observed below 30% relative humidity; rooms are maintained at 40% to 50% RH, and 316L stainless steel contact surfaces are earthed. When relative humidity exceeds 60%, the dihydrochloride mass increases by moisture uptake and the blend may adhere to tablet punches.
The dihydrochloride monohydrate is selected for tablets, capsules, powders, granules, and premixes because it is a solid at ambient temperature and compatible with direct compression excipients. The digluconate solution is selected for liquid preparations because it is pumpable, miscible with water, and easily diluted to final use concentrations of 0.05% to 1.0% w/v. The dihydrochloride is not freely soluble in water; published data for veterinary-specific dissolution profiles is limited, but the compendial description is “sparingly soluble” to “slightly soluble” depending on monograph and temperature. This solubility contrast means that a tablet cannot be substituted with the digluconate without reformulation because the liquid salt would plasticize the matrix and affect dissolution.
For tablets with more than 10% w/w chlorhexidine dihydrochloride, wet granulation is normally used rather than direct compression. The wet mass is dried in a fluid-bed dryer with inlet air not exceeding 65 °C to a loss on drying of 1.0% to 2.5%. Tablet hardness is set between 50 N and 80 N for non-chewable tablets, with friability tested according to USP <1216> at not more than 1.0%. For capsules, the blend is filled to a target weight variation of not more than 3% relative standard deviation, with powder flow adjusted to a compressibility index below 25% per USP <1174>. Magnesium stearate is used with caution above 0.5% w/w because the hydrophobic film can delay release; if disintegration exceeds 15 min in purified water at 37 °C per USP <701>, the lubricant level is rebalanced.
Wet granulation is performed in a high-shear mixer with chopper speed 1000 rpm to 1500 rpm; granulation liquid is purified water or an aqueous povidone solution at 5% w/w. The granules are dried in a fluid-bed processor with an inlet air temperature not exceeding 65 °C. Uniformity of the dried granules is checked by HPLC after sampling at 10-minute intervals from the fluid bed. Overdrying below 0.5% moisture creates fines and electrostatic segregation, while residual moisture above 2.5% can cause tablet picking or capsule shell softening. For premixes, chlorhexidine dihydrochloride is mixed with lactose monohydrate in a ribbon blender at 2% to 5% active loading, but the resulting premix is intended for dilution into antiseptic wash solutions rather than for incorporation into animal feed unless a specific marketing authorization in the target jurisdiction allows that use.
Chlorhexidine digluconate concentrate is diluted with deionised water to final concentration. Mixing vessels are fabricated from 316L stainless steel or high-density polyethylene; prolonged contact with some nylon filter membranes removes chlorhexidine by cationic adsorption, so filter compatibility is validated by assay recovery at the intended concentration. The finished solution is stored at pH 5.0 to 7.5. Alkalinity above 8.0 precipitates the cation. Anionic excipients such as sodium lauryl sulfate, alginates, and carboxymethylcellulose sodium cause precipitation or loss of antimicrobial activity and should not be combined without compatibility testing. Hard water with carbonate hardness above 300 mg/L as CaCO₃ can produce cloudiness; purified water is preferred.
Injectable formulations are not interchangeable with topical solutions. Chlorhexidine must not enter the middle ear, subarachnoid space, or exposed meninges because of established ototoxicity and neurotoxicity. For multi-dose injection products, the only veterinary-relevant use is as an antimicrobial preservative at concentrations at or below 0.01% w/v, and only where target-species data support the specific route and dose. Published data for this specific configuration is limited; a formulation intended for injection should therefore be developed under a veterinary marketing authorization, not by direct substitution from a topical solution formula. Preservative efficacy must be demonstrated by antimicrobial effectiveness testing according to Ph. Eur. 5.1.3 or USP <51>.
Chlorhexidine dihydrochloride monohydrate is hygroscopic above 60% RH. At 25 °C and 75% RH, open-pan hold times longer than 8 h produce visible surface wetting and can reduce assay when the powder is subsequently sampled for content uniformity. Closed containers with desiccant or dry nitrogen purge are required for intermediate storage. The digluconate concentrate remains solution-stable under normal warehouse conditions, but freezing below 0 °C can cause phase separation with slow redissolution upon thawing. Long-term stability studies are designed according to ICH Q1A for the selected packaging; stability-indicating HPLC detects any increase in 4-chloroaniline. The assay limit for 4-chloroaniline should be linked to the degradation threshold established in the current monograph rather than to a generic total-impurity limit.
Chlorhexidine is a cationic bisbiguanide rather than a halogen-releasing complex, a quaternary ammonium compound, or a diphenyl ether. Both chlorhexidine and benzalkonium chloride disrupt the bacterial cytoplasmic membrane, but chlorhexidine has two cationic biguanide centres and two chlorophenyl rings per molecule, which yields a stronger and longer residence on negatively charged skin and mucosal surfaces. Comparative efficacy is not determined by chemistry alone; suspension tests such as EN 1656 for veterinary bactericidal activity and EN 1040 for basic bactericidal activity should be run with the same target species isolates and organic soiling because contact time rankings change with formulation.
Povidone-iodine releases free iodine and has broader activity against non-enveloped viruses and bacterial spores under certain test conditions, whereas chlorhexidine is not sporocidal and has limited efficacy against mycobacteria. Chlorhexidine is often used where residual activity and low staining are required, but this must be validated by test standard. Triclosan has a different target enzyme, enoyl-acyl carrier protein reductase, leading to a different minimum inhibitory concentration profile; cross-resistance to chlorhexidine mediated by nonspecific efflux pumps has been reported, so veterinary mastitis isolates should be monitored by broth microdilution rather than assumed susceptible.
Chlorhexidine diacetate may appear in some veterinary formulations as a more water-soluble solid than the dihydrochloride. The diacetate is not a direct drop-in because the acetate counterion contributes different mass and dissolution characteristics. When a product specification references only “chlorhexidine,” the salt form must be clarified; otherwise assays and cation concentrations will deviate.
The veterinary-grade API differs from industrial disinfectant raw material principally in the release specification and documentation package. Industrial material may carry broad total-impurity tests but does not routinely include a Veterinary Active Substance Master File, GMP batch records, or the same 4-chloroaniline control. A veterinary-grade batch is tested for residual solvents, elemental impurities, and microbial limits; the certificate of analysis provides the lot number, manufacture date, retest date, and storage instruction. These records are necessary for finished product batch release under veterinary GMP requirements and for regulatory inspection. When a finished veterinary dosage form is assembled from this API, the batch record should include the incoming API lot, its residual solvent and 4-chloroaniline values, and the salt-form conversion factor. This level of traceability is necessary because chlorhexidine cation concentration cannot be inferred from a simple powder weight when the salt or hydration state is ambiguous.
