Products
| HS Code | 812095 |
| Product Name | 100% Isopropyl Alcohol (IPA), Non-sterile |
| Chemical Formula | C3H8O |
| Cas Number | 67-63-0 |
| Molecular Weight | 60.10 g/mol |
| Appearance | Clear colorless liquid |
| Odor | Sharp, alcoholic, slightly sweet |
| Purity | 100% isopropyl alcohol (anhydrous) |
| Boiling Point | 82.5 °C (180.5 °F) |
| Melting Point | -89.5 °C (-129.1 °F) |
| Flash Point | 11.7 °C (53.1 °F) closed cup |
| Autoignition Temperature | 399 °C (750 °F) |
| Density | 0.786 g/cm3 at 20 °C |
| Vapor Density | 2.07 (air = 1) |
| Vapor Pressure | 33 mmHg at 20 °C |
| Solubility | Miscible with water, ethanol, ether, and most organic solvents |
| Refractive Index | 1.377 at 20 °C |
As an accredited 100% Isopropyl Alcohol (IPA), Non-sterile factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | One 16 fl oz (473 mL) HDPE bottle with child-resistant cap, labeled clearly, containing 100% isopropyl alcohol, non-sterile. |
| Container Loading (20′ FCL) | Loading 20' FCL: 100% Isopropyl Alcohol (non-sterile) packed in drums, securely braced, with flammable goods signage and segregation. |
| Shipping | Ship as UN1219, Isopropanol, Class 3 Flammable Liquid, PG II. Use grounded, tightly sealed containers in approved DOT/UN packaging with proper hazard labels. Segregate from oxidizers and ignition sources. Provide shipping papers, placards, and emergency response information. Observe modal regulations (49 CFR/IATA/IMDG) and avoid passenger aircraft transport. |
| Storage | Store in tightly sealed, original or compatible containers in a cool, dry, well-ventilated area away from direct sunlight, heat, sparks, and open flames. Keep separated from strong oxidizers and incompatibles. Use explosion-proof equipment and grounded containers to prevent static discharge. Ensure the storage area is clearly labeled for flammable liquids. |
| Shelf Life | Shelf life: 3 years unopened from manufacture. Once opened, use within 12 months to prevent evaporation and contamination. |
On coil-coating and automotive body-in-white lines, non-sterile 100% isopropyl alcohol is introduced only after alkaline degreasing and phosphate conversion, where it functions as an evaporative final rinse for removing residual oils, fingerprints, and phosphate salts. The solvent wipe step is governed by SSPC-SP 1 for solvent cleaning and the surface cleanliness grades in ISO 8501-1:2007; on aluminium skin panels for structural adhesive bonding, ASTM D2651-01 includes solvent wipe as a permitted contaminant removal method, though water-break testing per ASTM F22-13 is frequently used as the line-side acceptance check. In this operation, 100% IPA is applied undiluted where evaporation below 40°C is required, but many coating lines dilute with deionized water to 70–90 vol% to reduce fire load and lower per-square-metre cost; at 90 vol%, evaporation of a 50 µm wet film at 22°C is generally below 25 seconds, while a 70 vol% film can require twice that interval. The application method is either robotic spray flooding followed by low-lint polyester wipes or oscillating brush applicators, with drying completed by compressed-air air knives at 0.2–0.5 MPa and 25–35°C. Production records show that at relative humidity above 75%, condensation on evaporatively cooled aluminium surfaces can cause visible coating blush and adhesion loss, which is why this solvent is not specified as a sole moisture barrier and must be followed by dry-off within 30–60 s. The terminal articles are painted or powder-coated metal parts—automotive door inners, structural brackets, steel office furniture panels, and aerospace skins—where surface cleanliness directly affects cross-hatch adhesion and salt-spray performance.
Flexographic and gravure ink rooms in flexible packaging plants use non-sterile 100% isopropyl alcohol as a side-press viscosity reducer for solvent-based NC/PU and PVB ink systems, particularly where ester and ketone solvents would swell photopolymer plates or exceed retained solvent allowances. Regulatory compliance for food-contact packaging is anchored to EC 1935/2004 and the Swiss Ordinance SR 817.023.21, with good manufacturing practice for printed surfaces defined in EC 2023/2006; raw-material REACH registration under EC No 1907/2006 is required for import. Addition ratios at the press are typically 2–8 wt% of finished ink for flexographic lines and 3–10 wt% for gravure, based on initial ink solids and circulation temperature; press-side make-up is adjusted only after viscosity measured in a DIN 4 mm flow cup at 25°C falls outside 18–28 s. In downstream production, pigments and nitrocellulose/polyurethane binders are first dispersed on a high-speed dissolver with a Cowles blade, then reduced with a solvent blend; non-sterile IPA is added last to adjust final viscosity, with ink temperature maintained below 35°C because IPA vapour pressure of 4.4 kPa at 20°C can generate flammable head-space vapour upon recirculation. Printing is conducted on central-impression presses at 150–350 m/min with drying tunnels operated below 45% LEL and air extraction rates matched to solvent load. Terminal products are solvent-based surface-printed or laminated PE, BOPP, paper labels, and aluminium foil lidstock.
Batch cleaning of printed circuit assemblies with non-sterile 100% isopropyl alcohol is constrained less by solvency than by the flammability envelope of 2.0–12.7 vol% in air and a closed-cup flash point near 12°C, which excludes open-top vapour degreasing and compels immersion or spray-under-immersion equipment with nitrogen-inerting options. The process fluid is usually blended with deionized water to 70–90 vol% IPA in order to dissolve weak organic acids and halide residues from no-clean solder pastes; the 20–30 vol% water fraction provides ionic solvation, while the IPA reduces surface tension to approximately 22 mN/m and penetrates under low-standoff flip-chip and QFN packages. Compliance for cleanliness acceptance is referenced to IPC J-STD-001 and IPC-CH-65, with contaminant levels checked by ionograph extraction and surface insulation resistance testing per IPC-TM-650 2.6.3.3. In production, the PCB batch basket is preheated to 25–30°C, immersed for 90–180 s in a 40 kHz ultrasonic bath with transducer power density 15–25 W/L, then transferred to a heated air knife at 65°C for 30–60 s; liquid rotation is maintained by 3–5 tank volume turnovers per hour. Existing contract-manufacturing records indicate that 100% IPA alone leaves visible tin-lead or SAC residues on dense 0201 packages, while 70–80 vol% blends reduce ionograph readings but increase drying time by 40–60%; published data for a single optimal ratio across all paste chemistries is limited. Terminal parts include stencils, misprinted PCBs, connector tails, and completed electronic control modules.
Non-sterile active pharmaceutical ingredient manufacturing uses 100% isopropyl alcohol as a process solvent, extraction solvent, and antisolvent for crystallisation, but the grade is excluded from final sterile rinses because it does not meet USP sterility requirements. Residual solvent control is anchored to ICH Q3C, where isopropanol is a Class 3 solvent with a permitted daily exposure of 50 mg/day; API release therefore requires quantification by USP <467> or an equivalent gas chromatographic procedure on both isolated intermediate and dried final material. As an antisolvent, the alcohol is charged to aqueous process liquors at volumetric ratios typically between 2:1 and 5:1, but the exact ratio is molecule-specific and must be validated; published data for a universal crystallisation ratio across all APIs is limited. Downstream equipment includes jacketed glass-lined reactors with retreat-curve impellers, where the solution is cooled to 0–20°C, aged for 2–8 h, filtered through pressure plate filters, and vacuum-dried at 40–50°C with condenser recovery of waste IPA. Non-product-contact reactor manways and transfer lines may use 100% IPA as a rinse after detergent cleaning; compliance with 21 CFR 211.67 and EU GMP Part II requires validated cleaning limits, but IPA is not used as the sole final rinse for product-contact surfaces in sterile filling lines. Terminal products include crystallised intermediates, purified bases, and isolated salts for further processing.
| Standard or regulation | Scope | Limit or procedure |
|---|---|---|
| ICH Q3C | Class 3 residual solvents | PDE 50 mg/day |
| USP <467> | Residual solvent quantification | Gas chromatographic procedure |
| 21 CFR 211.67 | Equipment cleaning and maintenance | Validated visual and analytical residues |
| EU GMP Part II | API process validation | Molecule-specific cleaning limits |
Hair fixative and scalp-lotion lines receiving non-sterile 100% isopropyl alcohol in bulk meter the solvent directly into stainless steel closed vessels, where it serves as a fast-evaporating carrier for vinyl acetate/crotonates or acrylate copolymers. Formulation inclusion is typically 20–50 wt% in pump hairsprays and 5–15 wt% in low-viscosity clear lotions; the rate is determined by final spray pattern, dry time, and consumer skin-safety assessment rather than polymer solubility alone. Manufacturing compliance is established under ISO 22716:2007 and Regulation (EC) No 1223/2009, with CIR safety evaluations providing upper bounds for leave-on use; if the final product is marketed as an OTC drug, FDA 21 CFR 210/211 applies instead of cosmetic GMP. The process uses a high-shear disperser at 15–25°C to pre-dissolve polymer in the alcoholic phase, followed by slow addition of water or humectants to avoid phase inversion; the mixture is filtered through 10 µm absolute filter cartridges and stored under nitrogen to limit moisture uptake, because IPA is hygroscopic and water content above 3% in 100% stock can alter final spray clarity and dry time. Terminal products are non-medicated hair styling sprays, clear scalp lotions, and quick-drying cosmetic setting sprays.
Continuous isopropyl acetate production via acid-catalysed esterification is a downstream outlet where non-sterile 100% isopropyl alcohol is consumed as a primary reactant, and the value chain pivots from cleaning or formulation to balanced chemical conversion. The feed specification requires low water content because esterification equilibrium shifts to the left with water accumulation; storage and transfer therefore follow ATEX 2014/34/EU zone-rated handling and REACH (EC) No 1907/2006, Annex II safety-data-sheet provisions, with flanged connections pressure-tested at 1.5 times working pressure and vapour recovery routed to thermal oxidation. In a fixed-bed or homogeneous acid-catalysed process, acetic acid and IPA are fed at a molar ratio of approximately 1:1.05 to 1:2.0, with excess alcohol recovered by distillation; the reactor is maintained at 80–110°C under reflux, and water is removed azeotropically to drive conversion above 90%. Downstream separation includes a reactive distillation column, a decanter, and two fractionation columns to produce isopropyl acetate at 99.5+ wt% purity; unreacted IPA is recycled. Published data for a single fixed-bed catalyst configuration is limited because licensors treat the catalyst and residence time distribution as proprietary. Terminal outputs are isopropyl acetate used in cosmetics and coatings, and aqueous acetic acid recovery streams.
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Identified by CAS registry number 67-63-0 and UN 1219, the product described as 100% isopropyl alcohol (IPA), non-sterile, is a technical or reagent-grade secondary alcohol with molecular formula C3H8O and molecular weight 60.10 g/mol. The term 100% does not denote absolute water-free material; industrial material typically carries an assay of 99.5% w/w to 99.9% w/w with water content determined by ASTM E203 Karl Fischer titration at or below 0.5% w/w. The non-sterile designation indicates that no terminal sterilisation cycle—such as gamma irradiation under ISO 11137 or ethylene oxide under ISO 11135—has been applied, and no sterility assurance level of 10-6 is claimed. No unified manufacturer model number exists across suppliers; the designator 100% isopropyl alcohol, non-sterile, is used to distinguish this product from sterile IPA, USP-grade IPA, and diluted 70% v/v aqueous IPA formulations. The specification data below follow the framework of ASTM D770 for isopropyl alcohol.
| Parameter | Determination method | Representative non-sterile technical specification |
|---|---|---|
| Assay as isopropanol | ASTM D770, USP 621 | 99.5–99.9% w/w |
| Water content | ASTM E203 | ≤0.5% w/w |
| Non-volatile residue | ASTM D1353 | ≤10 mg/L |
| Acidity as acetic acid | ASTM D1613 | ≤0.002% w/w |
| Density at 20 °C | ASTM D4052 | 0.785–0.789 g/mL |
| Closed-cup flash point | ASTM D56 | 12 °C |
| Refractive index n20/D | ASTM D1218 | 1.3770–1.3780 |
The material is manufactured by direct hydration of propylene or by hydrogenation of acetone, followed by extractive distillation or molecular sieve drying to achieve the near-anhydrous assay. Residual water is intentionally limited because water competes with IPA for polar soil wetting and slows the evaporation rate on substrates where moisture sensitivity is critical. However, the product remains hygroscopic, and containers left uncovered absorb atmospheric water. The closed-cup flash point of 12 °C places the product in NFPA 30 Class IB flammable-liquid category; the lower flammable limit is 2.0% v/v and the upper flammable limit is 12.7% v/v. Occupational exposure limits include an ACGIH TLV-TWA of 200 ppm, an ACGIH TLV-STEL of 400 ppm, and an OSHA PEL of 400 ppm averaged over an 8-hour shift.
The biocidal action of isopropanol requires an aqueous concentration window of 60% v/v to 80% v/v for maximum protein denaturation and membrane disruption. At near anhydrous concentration, contact time before evaporation is reduced, and the alcohol tends to coagulate surface proteins into a protective layer that can arrest penetration into bacterial cells. Alcohol-based hand rub and surface disinfection testing under EN 13697 or ASTM E1153 therefore normally uses 70% v/v formulations rather than 100% non-sterile IPA. The 100% product is assigned to solvent cleaning and degreasing operations where antimicrobial efficacy is not the controlling performance attribute. For sporicidal activity, published data for this specific configuration is limited, and bacterial spores are considered resistant to alcohols at any concentration unless an oxidising co-agent is present. Use of 100% non-sterile IPA as a terminal disinfectant in pharmaceutical cleanrooms without a validated dilution step is therefore outside recognized standard practice.
| Characteristic | 100% IPA, Non-Sterile | 70% v/v Aqueous IPA | Sterile 100% IPA |
|---|---|---|---|
| Water content | ≤0.5% w/w | Diluted with purified water to 70% v/v IPA | ≤0.5% w/w |
| Sterility assurance | None claimed | None claimed | Terminal sterilisation; SAL 10-6 under ISO 11137 |
| Primary function | Solvent cleaning, degreasing, dilution feed | Surface disinfection, hand hygiene | Aseptic cleaning, sterile surface rinse |
| Reference standard | ASTM D770 | EN 13697 | ISO 11137 |
| Typical package | Bulk drums, IBCs | Trigger sprays, pre-wetted towelettes | Sterile bottles, single-use vials |
Within printed circuit board assembly, 100% non-sterile IPA is dispensed through PTFE needle valves and benchtop stencil-cleaning stations to remove Type RMA rosin flux residues and no-clean solder pastes before conformal coating. The low water content reduces ionic contamination when surface insulation resistance is tested under IPC-TM-650 method 2.6.3.7, with resistance values typically recovered above 108 Ω when the board is fully dried at 60 °C for 30 minutes. The solvent is applied by immersion, aerosol, or engineered wipes. Prolonged exposure to elastomeric seals in peristaltic pumps can cause swelling unless seals are EPDM or PTFE-encapsulated. Because IPA is hygroscopic, open containers absorb moisture from ambient air, shifting the water content from 0.2% w/w toward 1.0% w/w within 8 hours at 60% RH, which reduces flux solubility and increases the risk of white residue on solder masks.
Long-term storage of 100% non-sterile IPA in high-density polyethylene drums and intermediate bulk containers is standard; HDPE permeability to IPA vapour at 20 °C is low but not zero, and pressure/vacuum venting should be used to control vapour pressure of 4.4 kPa at 20 °C. For transfer piping, 316L stainless steel and PTFE-lined hoses are preferred. Anhydrous IPA can react slowly with aluminium and aluminium alloys in the presence of adsorbed water or acid impurities to form aluminium isopropoxide; therefore uncoated aluminium pumps, spray heads, and storage tanks are not recommended for continuous contact. Plasticiser extraction from flexible PVC tubing can raise non-volatile residue above the specification limit of 10 mg/L in ASTM D1353 testing. Under high-humidity conditions above 60% RH, product transfer should use dry nitrogen blanketing to maintain the water specification below 0.5% w/w. The material is not compatible with strong oxidizers, acetyl chloride, or sodium hypochlorite bleach; the bleach reaction can generate chloroform and heat.
In high-performance liquid chromatography system maintenance, 100% non-sterile IPA is used as an organic flush solvent for reversed-phase column regeneration and as a diluent in some normal-phase mobile phases. Its absorbance cutoff near 205 nm makes it less suitable for low-UV detection below 210 nm than acetonitrile; method validation under USP 621 should confirm baseline noise at the detection wavelength. Non-sterile technical product that is not filtered through a 0.2 µm membrane may carry particulate matter and is not a direct replacement for HPLC-grade IPA in detector lines. Filtration through 0.2 µm PTFE syringe filters and verification of particle counts below 10 particles/mL at 10 µm are required for use in UHPLC systems. The material should not be stored in oxygen-permeable containers with continuous air exposure; periodic peroxide testing is advisable if the product is held beyond the supplier retest interval.
In ISO Class 7 cleanrooms, sterile IPA is normally dispensed from 0.2 µm filtered, gamma-irradiated bottles to maintain low bioburden. Non-sterile 100% IPA can be introduced only for non-product-contact cleaning of equipment surfaces where the cleaning procedure includes a downstream sanitising step with a validated sporicidal agent. The non-sterile designation means the container-closure system was not validated for sterility assurance under ISO 11135 or ISO 11137, and bioburden is not controlled by the supplier; microbial examination under USP 61 and USP 62 may be required before use in regulated areas. When diluted to 70% v/v with water meeting USP purified water specifications, the resulting disinfectant requires a separate bioburden and efficacy assessment under ASTM E1153 or EN 13697 before use on grade A/B surfaces. Unopened product stored at 20–25 °C in original sealed drums has a typical retest interval of 12 months for assay and water content; published data for longer storage is limited, and each batch should be re-certified before use in regulated applications.
For bulk storage at 20–25 °C, the product is filled into 200 L HDPE drums or 1000 L intermediate bulk containers under nitrogen blanket. The vapour space should be inerted where possible, and pressure vacuum relief devices should be set to limit breathing losses. The closed-cup flash point of 12 °C requires storage in a flammable-liquid cabinet meeting NFPA 30 and local fire code. Under 49 CFR 172.101, the material is classified as UN 1219, hazard class 3, packing group II. Grounding and bonding during drum transfer are mandatory because static discharge can ignite vapour above the lower flammable limit of 2.0% v/v. The product is intended for industrial and laboratory solvent use only and is not a finished pharmaceutical ingredient, not a sterile drug product, and not a direct-use disinfectant without dilution and validation where biocidal activity is required.