| HS Code | 399173 |
| Chemical Name | Propan-2-ol (Isopropyl alcohol) |
| Cas Number | 67-63-0 |
| Molecular Formula | C3H8O |
| Molecular Weight | 60.10 g/mol |
| Appearance | Clear, colorless liquid |
| Solubility | Miscible with water and most organic solvents |
| Assay | 99.0% to 100.5% w/w (on anhydrous basis) |
| Specific Gravity | 0.785 to 0.790 at 20°C |
| Boiling Point | 82.5°C at 760 mmHg |
| Water Content | ≤0.5% w/w |
As an accredited Isopropanol 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 | Packaged in 25 kg sealed, moisture-proof drums with tamper-evident closures, ensuring safe handling and stability for veterinary pharmaceutical formulations. |
| Container Loading (20′ FCL) | One 20′ FCL container loaded with Isopropanol Veterinary Grade API, properly packed, palletized, secured, and sealed for pharmaceutical manufacturing use. |
| Shipping | Ship as hazardous material: isopropanol (UN1219, Class 3, PG II) in grounded, sealed, corrosion-resistant containers away from heat, sparks, and oxidizers. Use approved dangerous-goods carriers, hazmat labeling, and proper documentation. Store below 25°C, protected from sunlight and moisture. Veterinary grade only—not for human use. |
| Storage | Store in tightly sealed, original containers in a cool, dry, well-ventilated area away from heat, sparks, open flames, and direct sunlight. Protect from moisture and incompatible materials such as strong oxidizers. Maintain container integrity to prevent leakage. Ensure area is clearly labeled and accessible only to authorized personnel. |
| Shelf Life | Shelf life: 24 months when stored in tightly sealed containers, protected from light and moisture, at controlled room temperature. |
Where a veterinary anthelmintic tablet formulation contains actives that hydrolyze under aqueous granulation conditions, an isopropanol-based wet granulation route is specified to avoid active degradation before compression. In a 300 L high-shear granulator fitted with a bottom-driven impeller and side chopper, a binder solution of povidone is prepared in isopropanol veterinary grade and sprayed at 6–10 wt% of the dry powder charge, equivalent to 18–30 kg of granulation fluid per 300 kg batch. Spray rate is held at 2.5–3.5 kg/min with impeller speed 80–120 rpm and chopper speed 1500–2500 rpm; the granulation endpoint is accepted when impeller power rises 18–25% above the dry-mix baseline. The wet mass is passed through a 2.0 mm grill sieve and transferred to a fluid bed dryer with inlet air at 50–60°C and exhaust humidity <15% RH; drying continues until residual isopropanol by headspace GC is below 5000 ppm, as specified for Class 3 solvents in VICH GL18(R2) and USP <467>. Over-wetting beyond 12 wt% leads to dough-like masses, a 25–40% increase in impeller power, and screen clogging that shifts granule size distribution from D50 120–180 µm to D50 >350 µm. The tablet compression blend is then lubricated with 0.5–1.0 wt% magnesium stearate and compacted to hardness 60–90 N on a rotary press. Compression outputs include film-coated anthelmintic tablets for sheep, beef cattle, and companion animals, water-soluble boluses, and chewable tablets.
In oral solution concentrates for mass medication via drinking water, isopropanol is used as a water-miscible co-solvent alongside propylene glycol or glycerol formal at 5–15% v/v of the finished concentrate to maintain solubility of weak-acid actives when farm water pH exceeds 8.0. The concentrate is manufactured in 1000 L jacketed stainless steel vessels with turbine agitation at 150–300 rpm and recirculation through a 5 µm cartridge filter. Isopropanol is pre-blended with the active phase before aqueous dilution to avoid localized supersaturation; addition of cold isopropanol at <10°C to concentrated electrolyte buffers has been observed in production batches to generate crystalline nuclei that blind downstream 0.45 µm membrane filters. Residual isopropanol is controlled as a Class 3 solvent under VICH GL18(R2) and Ph. Eur. 5.4, with an accepted PDE of 50 mg/day; the diluted drinking water concentration is checked against species-specific daily water intake records. Isopropanol-containing concentrates must not be flushed or CIP-mixed with hypochlorite or other strong oxidizer sanitizers because the resulting exothermic oxidation increases acetone content and can challenge stainless steel passivation. Final dosage formats include oral solution concentrates, farm-reconstituted soluble powder sachets, and bulk drinking water additives for poultry and swine.
To reduce polymorphism risk and tighten particle size distribution before final suspension or solution compounding, isopropanol is used as an antisolvent and recrystallization medium for sterile veterinary injectable actives. The precipitation step charges a filtered active solution into isopropanol at 4–8 solvent volumes relative to active mass, with the antisolvent maintained at −5°C to 5°C in a 200 L glass-lined reactor under continuous marine impeller agitation at 120–200 rpm. After crystal growth, the slurry is filtered through a 0.22 µm compatible membrane and washed with pre-chilled isopropanol to remove mother liquor. Drying is performed in an agitated vacuum dryer at 40–50°C and −0.08 MPa until residual isopropanol is ≤1000 ppm rather than the general 5000 ppm Class 3 limit, because injectable products with a daily dose above 10 g require an Option 2 calculation under ICH Q3C/VICH GL18(R2). Production-scale failure modes include agglomeration of charged micronized powders in stainless steel ribbon dryers below 20% RH and residual solvent trapping when the vacuum line condenser rises above −10°C. Direct inclusion of isopropanol as a final injectable vehicle is not recommended because of local irritancy and haemolysis threshold data. Finished sterile forms include sterile injectable suspensions, lyophilized powders for injection, and intra-mammary infusions.
Companion animal hard capsule formulations with acid-labile and moisture-sensitive actives are prepared by layering drug-loaded suspensions onto microcrystalline cellulose or sugar spheres in a Wurster fluidized bed processor using isopropanol as the main spray solvent. The suspension is prepared with 5–8 wt% binder solids in isopropanol veterinary grade and sprayed at 8–14 wt% of the core seed charge. Inlet air is maintained at 45–55°C with a dew point below 3°C; product temperature is kept at 28–33°C by adjusting spray rate to 2.0–2.5 g/min per kg of core material. When the spray rate exceeds 2.5 g/min per kg, agglomeration occurs in the lower partition gap and the yield of 16–20 mesh coated pellets decreases by up to 15% in representative 100 kg batches. Finished capsules are subjected to residual solvent analysis by USP <467> headspace GC after extraction; acceptance is 5000 ppm or lower depending on capsule mass and species-specific dosing. Although general Wurster layering practice is established, published data for this specific low-dose feline sprinkle capsule configuration is limited; the 2.0–2.5 g/min per kg spray rate range should be confirmed through pilot-scale design of experiments before registration batches. The process avoids water-induced degradation of proton-pump inhibitor and macrolide actives that show >5% drug-related loss in aqueous granulation at 60°C. Release forms include enteric-coated hard gelatin capsules, HPMC capsules for cats, and sprinkle capsules for equine administration.
After blending coccidiostat and antimicrobial growth promoter actives onto soybean meal or corn cob carriers, a low-moisture granulation route with isopropanol is applied to bind active micro-particles without introducing free water that could activate mold growth in finished feed premixes. The liquid addition is limited to 2–5 wt% of the premix batch; a 500 kg ribbon blender fitted with a spray bar at 4–6 bar atomizing pressure and paddle speed 20–30 rpm distributes the isopropanol solution evenly across the carrier. The wetted mass is dried on a continuous belt dryer at 55–65°C, with residual isopropanol monitored by gas chromatography to stay below 5000 ppm under VICH GL18(R2), where the active is approved as a coccidiostat or zootechnical additive under EU Regulation 1831/2003. Process records show that spraying above 6 wt% causes corn cob carrier swelling, raises angle of repose above 45°, and produces non-uniform active distribution when the premix is diluted into complete feed at 1:100. Isopropanol addition also requires dust extraction rated for flammable vapor atmospheres during spraying; the dryer exhaust is kept below 25% LEL by continuous flammable gas detection. The dilute-to-feed chain produces medicated premix powders, granulated concentrate premixes for pelleted feed, and mineral supplement premixes for ruminants.
Otic drying solutions and dermatological washes for dogs and cats are formulated with isopropanol at 10–50% v/v as a keratolytic, drying and preservative-enhancing solvent, typically combined with boric acid, salicylic acid, or chlorhexidine. Regulatory compliance for these products includes Ph. Eur. 5.4 for residual solvent and isopropanol purity, USP <467> for limit testing, and Ph. Eur. 5.1.4 for microbiological quality of non-sterile topical preparations. Manufacturing is performed in ATEX-rated stainless steel mixing tanks with nitrogen blanketing because isopropanol vapor in air is flammable at 2–12% v/v; transfers use pneumatically operated, grounded diaphragm pumps. Filling lines for 15–120 mL dropper bottles and spray bottles are operated at 10–25°C to maintain viscosity below 3 mPa·s and prevent intermittent fill weight variation above ±1.5%. A production-failure mode is the formation of a white precipitate when isopropanol above 25% v/v is added too rapidly to chilled chlorhexidine gluconate concentrates, causing flocculation and filter blockage. Concentrations above 50% v/v are contraindicated on ulcerated or excoriated ear epithelium, and the product must not be combined with hydrogen peroxide or iodine-based cleaners due to oxidation reactions and irritant by-products. Packaged presentations include otic drying solutions, ear cleaning solutions, paw cleaning sprays, and topical antifungal wipes.
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The product identified by model codes IP-VET-99.9-EP and IP-VET-99.9-USP is supplied as a clear, mobile liquid in 2.5 L, 5 L, 20 L, and 200 L containers. Packaging is high-density polyethylene or 316L stainless steel with nitrogen overlay for volumes above 20 L. The designation “API-grade” is a GMP and monograph-alignment statement rather than a pharmacological classification; isopropanol is included as a pharmaceutical processing solvent, granulating liquid, coating solvent, extraction solvent, and equipment cleaning agent for veterinary tablet, capsule, powder, granule, premix, solution, and injection-component manufacturing. Representative release values include isopropanol content not less than 99.5% by gas chromatography, water not more than 0.1% w/w by Karl Fischer titration, non-volatile residue not more than 20 mg/L, and aldehyde/ketone content controlled below the relevant monograph threshold. The dynamic viscosity is approximately 2.04 mPa·s at 25 °C, which permits filtration through 0.45 µm polyvinylidene fluoride membranes in solvent delivery lines. The normal boiling point is 82.6 °C, and the vapour pressure at 20 °C is approximately 4.4 kPa.
Because the material is a flammable liquid with a closed-cup flash point near 12 °C and a lower explosion limit of approximately 2% v/v, storage and processing require electrically classified areas, local exhaust ventilation, and nitrogen blanketing where vessel headspace oxygen concentration must remain below the limiting oxidant concentration for the specific equipment configuration. The product is not supplied as a direct parenteral vehicle. In injection manufacturing, it is used as a cleaning or extraction solvent and must be removed before depyrogenation and filling.
Bulk technical solvent is frequently marketed on a two-parameter basis—assay and water—and may contain uncontrolled benzene, methanol, acetone, organic peroxides, and particulate matter. Veterinary-grade material differs in its specification envelope. The current representative specification includes methanol not more than 100 ppm, benzene not more than 2 ppm, peroxides not more than 0.005%, and UV absorbance at 230 nm not more than 0.30 AU, at 260 nm not more than 0.10 AU, and at 280 nm not more than 0.01 AU. Density at 20 °C is controlled from 0.785 g/mL to 0.787 g/mL by ASTM D4052, and refractive index is controlled from 1.376 to 1.378.
| Parameter | Representative release criterion | Method |
|---|---|---|
| Isopropanol content | 99.5% minimum by GC area normalization | Ph. Eur. 2.2.28 |
| Water | 0.1% w/w maximum | ASTM E203 / Ph. Eur. 2.5.12 |
| Non-volatile residue | 20 mg/L maximum | Ph. Eur. 2.4.16 |
| Aldehydes and ketones | 0.02% as acetone maximum | GC or compendial colorimetric procedure |
| Methanol | 100 ppm maximum | Ph. Eur. 2.2.28 |
| Benzene | 2 ppm maximum | Ph. Eur. 2.2.28 |
| Peroxides | 0.005% maximum as H2O2 | Iodometric titration |
| UV absorbance | 230 nm not more than 0.30 AU; 260 nm not more than 0.10 AU; 280 nm not more than 0.01 AU | Ph. Eur. 2.2.25 |
| Density at 20 °C | 0.785 g/mL to 0.787 g/mL | ASTM D4052 |
Compared with denatured isopropanol, the veterinary grade excludes denatonium benzoate and methyl ethyl ketone. Compared with recycled solvent, it avoids cross-contamination with phenolic or halogenated residues from unrelated industrial operations. Compared with ethanol veterinary grade, isopropanol has a higher octanol-water partition coefficient and a lower flash point; the two are not interchangeable without revalidation of granule porosity, residual solvent profile, and drying endpoint. Supply documentation includes batch records, residual solvent statements, packaging certifications, and stability data, which are not generally available from technical distributors.
In moisture-sensitive active pharmaceutical ingredients, water-based granulation can initiate hydrate formation, degradation, or premature binder hydration. Isopropanol is used as the granulating liquid either neat or in a water-isopropanol mixture. In high-shear granulators with impeller tip speeds between 4 m/s and 10 m/s, the material is sprayed through a nozzle at a controlled rate to maintain a mass median granule diameter typically between 150 µm and 500 µm. Drying is conducted in fluid-bed dryers with inlet air temperature of 35 °C to 55 °C and exhaust relative humidity below 10%. Process analytical technology may use near-infrared or headspace gas chromatography to confirm residual isopropanol below 0.5% in the dried granule, the ICH Q3C-based limit for Class 3 solvents. Because of flammability, the granulation suite is electrically classified, and the fluid-bed dryer is inerted with nitrogen where local regulations require.
For film coating of tablets, isopropanol may replace or supplement water in polymeric coating dispersions when the substrate is water-sensitive. The coating pan is fitted with solvent-resistant silicone or PTFE gaskets and operated under negative pressure with vapour recovery. Spray rate is balanced against pan exhaust temperature and humidity to avoid tablet erosion or logo bridging. In capsule manufacturing, isopropanol is not used as a gel shell component; its role is limited to solvent-based cleaning of capsule filling machine contact parts, banding preparation where permitted, and extraction of coated pellets for analytical recovery. In powder and premix operations, the material supports adsorption of liquid actives onto carriers and preparation of non-aqueous liquid premixes. Residual solvent is reduced by vacuum drying or evaporative blending before packaging.
Production-scale fluid-bed drying of isopropanol-wet granules requires a solvent-specific drying curve. The constant-rate plateau is shorter than for water-wet granules because of the lower heat of vaporization, but exhaust gas monitoring remains critical to avoid exceeding the lower explosion limit. Batch records typically document granulation spray rate, exhaust dew point, and final loss on drying. No universal endpoint applies; the endpoint must be established for each formulation by correlating loss on drying with headspace gas chromatography.
Injection-component processing presents the narrowest operating boundary. Isopropanol is used in cleaning cycles for stainless steel vessels, transfer lines, and filling needles after organic residues have contacted the surface. The cleaning sequence typically includes a wash with heated isopropanol, drainage, and a minimum of two rinses with water for injection, followed by dry heat or steam sterilization. Finished injection samples are analyzed by headspace GC against USP <467> or Ph. Eur. 2.4.24 to demonstrate that isopropanol is not detected above the reporting threshold or is below the target species-specific limit. The ICH Q3C Class 3 permissible daily exposure for isopropanol is 50 mg/day for human pharmaceuticals; veterinary acceptance is established according to VICH GL18, and the concentration limit in the finished dosage form is 0.5% when the human default is applied. For food-producing species, tissue residue and withdrawal period implications must be assessed by the marketing authorization holder because isopropanol is not an inert excipient with an automatic maximum residue limit. Published data for species-specific toxicokinetic thresholds in all veterinary target groups is limited.
Cleaning validation acceptance limits for isopropanol as a cleaning agent are not fixed solely by ICH Q3C; they are derived from the carryover of the subsequent product. A conventional limit is 10% of the permissible daily exposure of the cleaned product or a visual clean criterion, whichever is lower, and typical swab recovery studies use stainless steel coupons spiked with isopropanol at 5 µg/cm² to 50 µg/cm². Recovery should be not less than 70% by headspace GC before routine swab limits are applied. Injection water rinses following isopropanol cleaning should be sampled for total organic carbon and oxidation-reduction potential as an index of residual solvent removal.
For oral solutions, isopropanol may be introduced as a co-solvent only when the finished product specification and stability data support its presence. The ICH Q3C default concentration limit of 0.5% applies to the total finished solution unless a species-specific limit is established under VICH GL18. The material is not compatible with strong oxidizers, acetyl chloride, or aluminum under acidic conditions, and prolonged storage under air may generate low levels of peroxide. When analytical methods require peroxide control, the material should be sparged with nitrogen and stored away from direct light.
Compatibility with 316L stainless steel, borosilicate glass, and polytetrafluoroethylene is documented. EPDM and butyl elastomers require immersion testing before prolonged exposure because solvent uptake can alter gasket compression set at elevated temperature. No single compatibility statement covers all equipment trains; each contact material must be evaluated under the actual temperature and pressure conditions of the cleaning or granulation cycle.
| Compliance area | Standard / clause | Application |
|---|---|---|
| Residual solvents in finished dosage forms | ICH Q3C Class 3 | Isopropanol PDE 50 mg/day, finished-product concentration limit 0.5% |
| Veterinary-specific residual solvent evaluation | VICH GL18 | Species-specific safety justification for food-producing animals |
| Residual solvent test method | USP <467>, Ph. Eur. 2.4.24 | Headspace gas chromatography for finished tablets, granules, premixes, solutions |
| Density testing | ASTM D4052 | Oscillating U-tube or pycnometer at 20 °C |
| Water testing | ASTM E203 | Volumetric Karl Fischer titration with anhydrous methanol-formamide solvent |
| Good manufacturing practice | 21 CFR 211, EU GMP Part II | Batch record review, change control, packaging release, and deviation management |
In tablet and granule applications, the material is not restricted to a single solvent loading. The optimum level is determined by granule porosity, binder solubility, and residual solvent removal capacity of the available dryer. Formulations with high binder viscosity may require a larger isopropanol fraction, but the drying endpoint must still meet the 0.5% residual solvent limit unless process-specific justification is filed. Capsule and premix applications follow the same residual solvent logic; the critical measurement is the finished-product headspace GC result rather than the initial solvent charge.
