| HS Code | 280691 |
| Product Name | Boric Acid Ear Drops Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Chemical Name | Orthoboric Acid |
| Molecular Formula | H3BO3 |
| Molecular Weight | 61.83 g/mol |
| Cas Number | 10043-35-3 |
| Appearance | White crystalline powder or colorless crystals |
| Solubility | Soluble in water and alcohol; freely soluble in glycerin |
| Assay | 99.5% to 100.5% on dried basis |
| Melting Range | Approximately 170.9°C |
| Microbial Purity | Complies with veterinary grade microbial limits |
| Application | API for veterinary ear drops, tablets, injections, capsules, powders, granules, premix, and solutions |
| Storage Condition | Store in tightly closed containers in a cool, dry place |
| Grade | Veterinary Grade API |
As an accredited Boric Acid Ear Drops 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 | 25 kg sealed double polythene-lined HDPE drums, tamper-evident closures, labeled for veterinary grade Boric Acid API use. |
| Container Loading (20′ FCL) | One 20′ FCL container, loaded with veterinary-grade Boric Acid API, safely packed in sealed drums for pharmaceutical manufacturing. |
| Shipping | Boric Acid veterinary grade API is shipped in sealed, moisture-proof containers with proper hazard labeling. Transport via courier or freight with compliant documentation, including safety data sheets. Ensure temperature-controlled, dry conditions and secure palletization. Deliveries handle tablets, injections, capsules, powders, granules, premix, or solutions with traceability and regulatory compliance. |
| Storage | Store Boric Acid Veterinary Grade API in tightly sealed, original containers in a cool, dry, well-ventilated area. Protect from moisture, excessive heat, and direct sunlight. Keep away from incompatible substances and food/feed products. Maintain room temperature below 25°C. Ensure containers remain closed when not in use to preserve stability and purity. |
| Shelf Life | Shelf life is 36 months from manufacture when stored tightly sealed in a cool, dry place, protected from moisture. |
In veterinary dermatology practice, boric acid is incorporated into acidifying otic solutions intended for canine otitis externa where Malassezia pachydermatis and Pseudomonas aeruginosa persist in the external ear canal. The veterinary grade API is first checked against the relevant Ph. Eur. and USP monographs for identity, assay, loss on drying, sulfates, heavy metals, and arsenic. A manufacturing batch is prepared in a 316L stainless steel jacketed mixing vessel equipped with a bottom magnetic stirrer and an external recirculation loop. Purified water is heated to 60–70 °C; boric acid is added through a vacuum transfer system to reach 2.0–2.5% w/v, which remains below the solubility limit of approximately 55.6 g/L at 25 °C. After complete dissolution and cooling to 22–25 °C, acetic acid or malic acid is metered to adjust pH to 3.2–4.0. The solution is then passed through a 0.45 µm polyethersulfone filter into a non-sterile holding tank. The acidified medium creates an environment that restricts bacterial and fungal proliferation, while boric acid contributes drying and weak antiseptic activity in the ear canal. Finished products are prepared under current good manufacturing practice for veterinary pharmaceuticals aligned with 21 CFR 211.
Bulk solution is sampled for clarity, pH by USP <791>, density, and microbial enumeration by USP <61> and USP <62>. Preservative effectiveness is evaluated per USP <51> because the multi-dose package may be used over 7–14 days. The absence of Pseudomonas aeruginosa is a specific acceptance criterion because this target pathogen can survive in low-pH aqueous environments if fill contamination occurs. The terminal product is filled into 15 mL or 25 mL high-density polyethylene bottles with an LDPE dropper insert and a polypropylene cap. The packaged otic solution is labelled for veterinary use only and is dosed by the prescribing veterinarian; the formulation is not intended for systemic administration.
Boric acid has a water solubility of approximately 55.6 g/L at 25 °C and 47.2 g/L at 20 °C. When a feline otic flush is formulated at 2.5% w/v, the nominal concentration is 25 g/L; however, the addition of sodium chloride, calcium acetate, or salicylic acid changes the ionic strength of the medium and may induce nucleation during cold-chain storage. A failure observed in production-scale compounding is crystal formation in the dip tube after storage at 2–8 °C, caused by temperature cycling and evaporative concentration at the bottle tip rather than by bulk solubility alone. This imposes a practical upper concentration limit near 2.5% w/v unless the pack is labelled for room-temperature storage and the closure is engineered to reduce moisture vapour transmission.
The manufacturing vessel is charged with purified water at 55–65 °C. Boric acid is added through a vacuum transfer system to control dust formation. The batch is mixed at 80–120 rpm with a scraped-surface agitator until dissolution is complete. After cooling to 18–20 °C, the pH is adjusted to 3.0–3.8 with lactic acid or acetic acid. The formulation is filtered through 0.45 µm polypropylene depth filters. Filling is executed on a peristaltic pump line at ambient temperature, and the first fill is subjected to a cold-cycle challenge at 4 °C for 72 h to confirm the absence of crystals. Terminal product is a ceruminolytic flush with boric acid as a drying and acidifying agent; salicylic acid at 0.5–1.0% w/v contributes keratolytic activity. The pack is a 100 mL LDPE squeeze bottle with a conical tip. The product is non-sterile and tested to USP <61>, USP <62>, and pH by USP <791>. Osmolality is not always specified in veterinary monographs, but formulators may target 250–350 mOsmol/kg to reduce feline ear irritation.
Boric acid functions as a tonicity and pH stabiliser in sterile ophthalmic irrigating solutions used for equine corneal lavage and periocular flushing. Unlike otic products, this dosage form must meet sterility and endotoxin requirements because the solution contacts the corneal surface. A representative composition is 1.2–1.5% w/v boric acid, 0.05–0.1% w/v sodium borate, and sodium chloride q.s. to an osmolality of 290–310 mOsmol/kg, with pH adjusted to 7.2–7.6. Boric acid is not the active antimicrobial in this preparation; it serves as a buffering and tonicity agent while contributing mild bacteriostatic character to the irrigating vehicle.
Manufacturing is conducted in a Grade D cleanroom with Grade A local protection under unidirectional airflow. The aqueous solution is compounded in a 316L stainless steel tank, filtered through a 0.22 µm hydrophilic PVDF sterilising grade filter, and filled by blow-fill-seal or glass vial filling equipment. The heat-stable borate system permits terminal steam sterilisation at 121 °C for 15 min in polypropylene containers; aseptic filtration is used for heat-sensitive LDPE ampoules. Release testing includes sterility per USP <71>, bacterial endotoxins per USP <85> with a limit of <0.5 EU/mL, pH per USP <791>, and osmolality per USP <785>. Particulate matter limits aligned with USP <789> for ophthalmic solutions are applied. Primary containers are 10 mL or 20 mL single-use LDPE or polypropylene ampoules. The terminal product is labelled for equine veterinary use; boric acid must not be used as a substitute for antibiotic therapy in infected corneas.
For exudative skin lesions on cattle and occasionally small ruminants, boric acid is compounded into astringent dusting powders at 5–10% w/w. The carrier is a mixture of kaolin, talc, and zinc oxide; boric acid is first passed through a 500 µm stainless steel mesh to remove agglomerates, then blended with the carrier in a double-ribbon mixer at 15–25 rpm for 15–20 min. The formulation absorbs moisture and creates an acidified skin surface that suppresses superficial bacterial and fungal proliferation in pustular dermatitis. The powder is not sterile and is not intended for open wounds that expose subcutaneous tissue. Boric acid absorption increases through damaged skin, and application over large surface areas is contraindicated because systemic exposure can produce renal and central nervous system effects.
Finished powder is tested for loss on drying <2.0%, particle size distribution by laser diffraction with D90 <75 µm, and microbial limits per USP <61> and USP <62>. The absence of Salmonella and Staphylococcus aureus is required. Packaging consists of a 250 g or 500 g HDPE jar with a polypropylene snap cap. The terminal product is applied as a thin film once daily or as directed by the veterinarian. Published data for specific absorption rates across intact and abraded bovine skin are limited; therefore, the label restricts use to localised application and excludes use on broken skin.
Boric acid powders and granules are filled into unit-dose sachets to produce a 2% w/v aqueous rinse when dissolved in 1 L of purified water. This presentation is used in veterinary hospital wards for superficial flushing of intact skin and for moist dressing changes. The granular form is produced by wet granulation in a high-shear mixer using purified water as the binding liquid; after granulation, the material is dried at 50–60 °C in a fluid-bed dryer until loss on drying is <1.0%. Granules are screened through 850 µm and 150 µm sieves to remove oversize and fines. Sachet filling is performed on a strip-pack machine in a low-humidity zone below 40% RH to prevent caking. Dissolution time is measured as ≤2 min at 25 °C in 1 L purified water with stirring at 100 rpm.
The boric acid rinse is not a substitute for chlorhexidine or povidone-iodine surgical scrubs and is not suitable for aseptic skin preparation. The reconstituted solution is non-sterile and must be used within 24 h because it lacks a preservative system. Release testing includes assay by alkalimetric titration after mannitol complexation, pH of the reconstituted solution, and microbial enumeration per USP <61> and USP <62>. Terminal packaging is a single-use aluminium foil sachet containing 20 g of powder or granular material. The sachet label states the dilution ratio and the 24 h discard interval for unused solution.
| Dosage form | Boric acid load | Target pH | Critical process condition | Release standard |
|---|---|---|---|---|
| Canine otic acidifying solution | 2.0–2.5% w/v | 3.2–4.0 | filtration at 0.45 µm, cooled to 22–25 °C | USP <61>, USP <62>, USP <791> |
| Feline ceruminolytic flush | 2.0–2.5% w/v | 3.0–3.8 | cold-cycle at 4 °C for 72 h | absence of crystals, USP <61>, USP <62> |
| Equine ophthalmic irrigation | 1.2–1.5% w/v | 7.2–7.6 | aseptic filtration at 0.22 µm | USP <71>, USP <85>, USP <785> |
| Bovine dusting powder | 5–10% w/w | — | ribbon mixer at 15–25 rpm | D90 <75 µm, USP <61>, USP <62> |
| Reconstituted rinse sachet | 2% w/v after dilution | 4.5–5.5 | dissolution ≤2 min at 25 °C | assay by alkalimetric titration, USP <61>, USP <62> |
Boric acid is occasionally incorporated into mineral premixes and research diets to supply elemental boron at nutritionally relevant concentrations in controlled ruminant and monogastric studies. The material is first milled to pass a 300 µm sieve and then blended with calcium carbonate, dicalcium phosphate, and magnesium oxide in a ploughshare mixer for 8–12 min. Boron content is targeted at 10–20 mg/kg of complete feed; the premix is diluted at 1:100 or 1:200 before final feed mixing. Regulatory acceptance is not uniform. In the European Union, boric acid is not universally authorised as an organic trace element source for food-producing animals under current feed additive regulations; use is confined to non-food research or jurisdictions where national law permits. The material must not be used in food-producing animal diets where local residue legislation prohibits boron salts.
Premix homogeneity is verified by sampling at 10 points and assaying boron by ICP-OES after microwave digestion; a relative standard deviation of <5% is a typical acceptance criterion. Published data for this specific configuration is limited, so each batch protocol is qualified by recovery studies. Terminal package is a 20 kg multi-wall paper bag with a polyethylene liner. The premix is labelled as a research or custom mineral premix; it is not a medicated feed and carries no therapeutic claim.
Boric acid is not established as an active pharmaceutical ingredient in tablet, capsule, or injectable veterinary formulations in current pharmacopoeias. Systemic exposure is associated with dose-dependent renal and central nervous system effects; boric acid is rapidly absorbed from the gastrointestinal tract and from serous cavities, and elimination is primarily renal. There are no compendial dissolution or sterility standards for parenteral boric acid products because no such licensed products exist in major markets. The extended dosage form listings in commercial supply therefore reflect the range of physical forms available for topical, otic, and ophthalmic compounding rather than a regulatory approval for oral or injectable administration. If a powder or granular grade is requested for capsule filling or tablet compression, the operation must be treated as investigational or historical; the material must not be incorporated into parenteral solutions because intravenous boric acid has a narrow toxic-to-therapeutic window.
Formulators evaluating solid dosage forms must also consider boric acid caking at relative humidity above 60% and its tendency to form hard agglomerates. Direct compression requires a milled grade with D90 <150 µm; dry granulation with a roller compactor is preferred because boric acid alone has poor flow. Quality control, if pursued, requires assay per the current Ph. Eur. boric acid monograph, loss on drying <0.5%, and heavy metals controlled per the same monograph. Published data for boric acid tableting parameters are limited; therefore, each development batch must be qualified on the specific rotary press used for production.
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Boric Acid Ear Drops Veterinary Grade API, model code BA-VG-102, is released as a white crystalline powder or granular product for veterinary pharmaceutical processing across multiple dosage forms: tablets, injections, capsules, powders, granules, premixes, and solutions. The active substance is defined by CAS 10043-35-3, molecular formula H3BO3, and relative molecular mass 61.83. The “ear drops” designation identifies the primary clinical aqueous use as an otic acidifier and antimicrobial support material, but the controlled release profile is expanded for solid and liquid compounding. The API is not a finished, sterile, ready-to-use ear-drop product. For otic solutions, the solid must be dissolved in purified water or a suitable physiologically compatible buffer, clarified through a validated filter train, and filled under the intended microbiological controls. The material is supplied with a certificate of analysis, a residual solvent statement, a TSE/BSE statement, and an ICH Q3D elemental impurity declaration. It differs from technical, food, and reagent boric acid by compendial identification, assay, heavy metal limits, microbial limits, and pharmaceutical change-control documentation.
Release testing is performed against the boric acid monograph where published, with additional controls for microbiological quality and elemental impurities. The following table summarizes core release criteria for a non-sterile veterinary API lot; individual contracts may tighten a limit if the intended finished product is an injection or an otic solution with elevated bioburden risk.
| Parameter | Method / Standard | Acceptance Criterion |
|---|---|---|
| Assay, dried basis | Titration after mannitol complexation | 99.5–100.5% |
| Loss on drying | Desiccator over silica gel | ≤ 0.5% |
| Chloride | Compendial limit test | ≤ 0.005% |
| Sulfate | Compendial limit test | ≤ 0.045% |
| Heavy metals | Colorimetric limit test | ≤ 0.002% |
| Arsenic | Gutzeit limit test | ≤ 5 ppm |
| Total aerobic microbial count | Ph. Eur. 2.6.12, USP <61> | ≤ 103 CFU/g |
| Total yeast and mold count | Ph. Eur. 2.6.12, USP <61> | ≤ 102 CFU/g |
Elemental impurity limits follow ICH Q3D for oral and otic routes; if the material is designated for a parenteral candidate, the risk assessment must address chromium, nickel, and copper contributions from stainless-steel processing equipment. Compendial monographs do not assign a universal particle-size limit, so the D10, D50, and D90 values are fixed by quality agreement with the dosage-form requirement. The product is not certified as sterile in its standard container; a sterile-grade lot requires additional terminal sterilization or aseptic processing and a Ph. Eur. 2.6.14 endotoxin certificate.
The aqueous solubility of boric acid is approximately 47 g/L at 20 °C and increases with temperature; therefore otic solutions above 4% w/v require heating or a cosolvent system. Boric acid behaves as a weak Lewis acid: the pKa value is approximately 9.24 at 25 °C, and dilute solutions are only mildly acidic. Formulators should not expect the same acidifying capacity as acetic or citric acids. In aqueous otic products, boric acid contributes to the maintenance of a weakly acidic environment, cerumen softening, and support of preservative systems; its intrinsic antimicrobial activity is limited and should not be assumed to satisfy USP <51> antimicrobial effectiveness testing or Ph. Eur. 5.1.3 preservative efficacy without challenge data.
A specific processing conflict occurs when the otic vehicle contains glycerol, propylene glycol, or another polyol with cis-diol functionality. Boric acid reacts reversibly with these compounds to form borate esters; this reaction lowers the measured pH and increases the apparent ionization of the boron species. If pH is measured immediately after boric acid addition and before ester equilibration, the value may overestimate the final pH by several tenths. Production batches should be equilibrated at the target fill temperature and re-measured before final pH adjustment. Filtration through 0.22 μm PVDF or polyethersulfone membranes is common. Stainless-steel 316L equipment is acceptable for boric acid solution processing; carbon steel should be avoided because acidic borate solutions promote corrosion and metal ion release.
Boric acid has a density near 1.435 g/cm3 and a crystalline habit that imparts moderate flow resistance. In tablet manufacture, the API is typically incorporated at low mass fraction after pre-sieving through a 0.5 mm screen or a comill to break agglomerates. Direct compression without a flow aid is not advised; blends containing boric acid at more than a few percent may show poor flow and die filling. High-humidity storage above 60% RH leads to surface water uptake and caking because the product is moderately soluble and can recrystallize at contact points. Loss on drying above the release limit should trigger re-drying or rejection for direct compression because residual water contributes to picking and sticking on rotary tablet press tooling.
Wet granulation with aqueous binder is feasible but introduces a compatibility boundary: boric acid can interact with polyhydroxy binders such as starch and certain cellulose ethers through borate ester formation, altering granule viscosity and final hardness. The granulation endpoint should be controlled by impeller power consumption or torque rather than fixed time alone. If the formulation is filled into hard capsules, the tamping pin or dosator settings are calibrated against tapped density; boric acid’s flow limitations may require a glidant and low-speed filling. Particle attrition during high-shear blending may increase fines, so blend uniformity sampling per USP <905> or Ph. Eur. 2.9.40 should be performed at the intended production scale.
Injectable and parenteral use of boric acid is constrained primarily by systemic toxicology rather than by chemical purity. Boric acid is not an established inactive ingredient for routine systemic intravenous veterinary formulations, and published data for this specific veterinary parenteral configuration is limited. Where a parenteral or intra-articular candidate is developed, the applicant must justify the borate dose on a species-specific and route-specific basis, including renal elimination capacity and local tissue tolerance. Endotoxin control by USP <85> or Ph. Eur. 2.6.14 is necessary but not sufficient; low endotoxin does not substitute for toxicological qualification. Boric acid solutions can be terminal-sterilized by autoclaving within closed containers if the headspace and venting are designed to prevent evaporative water loss and subsequent concentration increase. Aseptic filtration through a 0.22 μm filter is also feasible. The API should not be combined with strong bases, high-concentration carbonate buffers, or polyols in parenteral formulation without measuring the resulting pH shift and boron speciation. The standard release certificate is for a non-sterile powder; a parenteral-grade lot must be ordered with additional endotoxin, bioburden, and residual solvent qualifications.
For powdered and granulated veterinary premixes, the principal risk is assay variation caused by segregation of the dense boric acid particles from lighter feed carriers. A granulated premix intermediate is preferred to direct single-mix powder addition. When dry blending is unavoidable, sampling should follow ISO 6497 for animal feeding stuffs, and the blend should be tested at top, middle, and bottom sampling points. Process capability should be demonstrated at the largest intended production scale because laboratory-scale uniformity is not predictive of silo or mixer discharge behavior. Boric acid is not highly hygroscopic, but drying for granulation should remain below 100 °C because prolonged heating near or above that threshold can initiate dehydration to metaboric acid species. Roller compaction and fluid-bed granulation are acceptable provided the binder system is checked for borate ester interaction with polyhydroxy binders.
The controlled product differs from lower-specification boric acid sources in documentary continuity, impurity control, and compendial assay. Technical-grade boric acid produced for glass, ceramics, or agriculture may contain arsenic, sulfate, and insoluble residues above pharmaceutical limits, and is not manufactured under a pharmaceutical quality system. Food-grade boric acid may have higher chemical purity than technical grade but does not carry TSE/BSE, residual solvent, or ICH Q3D elemental impurity declarations in the pharmaceutical format. Reagent-grade material may be analytically pure but is not released under GMP and may lack microbial and endotoxin testing. The following table summarizes the main controls that distinguish this product from non-pharmaceutical sources.
| Control Attribute | Veterinary API | Technical Grade | Food Grade | Reagent Grade |
|---|---|---|---|---|
| Compendial assay range | 99.5–100.5% | No pharmaceutical range | No pharmaceutical range | May be high, but not compendial |
| Heavy metal limit | ≤ 0.002% | Not routinely controlled | Limited by food codex, not pharmaceutical | Variable |
| Microbial count | Specified per Ph. Eur. 2.6.12 | Not tested | Variable | Not tested |
| Pharmaceutical documentation | CoA, TSE/BSE, residual solvent, ICH Q3D | Safety data sheet only | Food safety certificate | Analytical CoA only |
| Endotoxin testing | Available for sterile-designated lots | Not available | Not available | Not available |
In tablet and capsule applications, the product replaces non-pharmaceutical boric acid because the low heavy metal content and controlled assay minimize batch-to-batch variance in highly diluted formulations. In powder and granule premixes, the pharmaceutical documentation supports veterinary regulatory filings; technical-grade material does not provide the same change-control or impurity traceability. In solution and otic work, the specified microbial limits and the option for an endotoxin-controlled lot reduce the bioburden load entering downstream sterile filtration. The material remains a medicinal substance of limited intrinsic potency and requires the same toxicological and preservative challenge validation as any other boric acid source; its differentiation is in controlled quality, not in a different chemical mechanism. For injectables, the availability of an endotoxin-controlled lot and the absence of non-compendial heavy metals are necessary preconditions, but local and systemic toxicology remains the limiting acceptance criterion.
