Isopropyl Alcohol Documentation Bundle Coa Sds Tds Ghs Label And Packing Certificate
2-Propanol (CAS 67-63-0; isopropyl alcohol, UN 1219) is supplied with the Isopropyl Alcohol Documentation Bundle: COA, SDS, TDS, GHS Label and Packing Certificate. The bundle separates lot-specific analytical evidence from regulatory hazard communication, physical property data, immediate container marking, and transport packaging verification. This distinction is operationally significant because the COA and TDS address product quality, while the SDS, GHS label, and packing certificate address transport and workplace hazard duties under different legal instruments.
Scope and documentation architecture for 2-propanol shipments
A complete shipment file contains five regulated or commercially standardized components. The Certificate of Analysis carries lot-specific test results; the Safety Data Sheet carries hazard and protective measures; the Technical Data Sheet carries product specification ranges and application-relevant physicochemical values; the GHS label carries immediate hazard pictograms and precautionary text; and the packing certificate verifies that the outer packaging conforms to the UN performance-tested packaging system. Each document has a distinct retention requirement. Quality-control records are typically retained under ISO 9001:2015 clause 8.6 or, where the material is used as a pharmaceutical processing aid, under 21 CFR 211.165. The SDS is updated in accordance with REACH Annex II and the receiving jurisdiction’s hazard communication standard.
| Document | Primary function | Key norm or standard |
|---|---|---|
| Certificate of Analysis | Lot-level analytical release data | ISO 9001:2015 clause 8.6; 21 CFR 211.165; USP–NF monograph |
| Safety Data Sheet | Hazard communication and risk management | REACH Annex II; CLP (EC) No 1272/2008; 29 CFR 1910.1200 |
| Technical Data Sheet | Product specification and physicochemical data | Supplier specification with ASTM or ISO test methodology |
| GHS Label | Immediate hazard marking | CLP (EC) No 1272/2008 Annex I; UN GHS Rev. 10 |
| Packing Certificate | Performance-tested packaging verification | UN Model Regulations; ADR, RID, IMDG Code, IATA DGR |
Lot release data in the COA for technical-grade 2-propanol typically include purity by gas chromatography with flame ionization detection, water content by Karl Fischer titration, acidity calculated as acetic acid, non-volatile residue, and density. In a representative bulk specification, assay is ≥99.5 area%, water is ≤0.05 wt%, acidity is ≤0.002 wt%, and non-volatile residue is ≤0.001 wt%. For pharmaceutical-grade material, the USP–NF monograph may set assay at ≥99.0% and water at ≤0.10%. The COA must identify the analytical method number, the lot number, the retest or expiration date, and the authorized release signature. A mismatch in retention time against the reference standard indicates possible contamination with acetone, 1-propanol, or other volatile impurities; therefore gas chromatographic retention time alignment is checked before integration.
The Safety Data Sheet is not a lot-specific document. It states the harmonized classification of 2-propanol under CLP (EC) No 1272/2008: Flam. Liq. 2, Eye Irrit. 2, and STOT SE 3. The associated hazard statements are H225, H319, and H336. Section 9 of the SDS lists flash point at 12 °C closed cup, boiling point at 82.4 °C, relative density 0.785–0.787 at 20 °C, vapor pressure 4.4 kPa at 20 °C, and vapor density relative to air 2.07. Section 14 identifies the material as UN 1219, Class 3, Packing Group II. Section 7 requires storage below 30 °C, grounding and bonding of transfer equipment, elimination of ignition sources, and ventilation in case of vapor accumulation. The SDS does not state whether the material is suitable for semiconductor cleaning, pharmaceutical crystallization, or topical disinfectant formulation; that determination belongs to the TDS and validated application data.
Does a Technical Data Sheet Adequately Describe Evaporation and Solvency Limits?
The TDS for 2-propanol commonly reports evaporation rate relative to n-butyl acetate as 2.8, dynamic viscosity as 2.43 mPa·s at 20 °C, surface tension as 21.7 mN/m at 20 °C, and Hansen solubility parameters of δD 15.8 MPa0.5, δP 6.1 MPa0.5, and δH 16.4 MPa0.5. These values indicate high polar and hydrogen-bonding solvency for resins, cellulosic derivatives, and polar soils. However, the TDS does not predict evaporation under a specific industrial dryer. In flexographic ink thinning, a 10–20 wt% addition of 2-propanol lowers efflux time when measured with a DIN 53211 flow cup or ASTM D4212 method, but the slope of the viscosity reduction varies with resin molecular weight, pigment volume concentration, and co-solvent ratio. A drawdown on wire-wound rods followed by dryer residence-time testing is therefore required because the TDS cannot capture forced-air evaporation under high relative humidity.
| Property | Published technical-grade range or value | Test method |
|---|---|---|
| Relative density at 20 °C | 0.785–0.787 g/mL | ASTM D4052-22 |
| Boiling point at 101.3 kPa | 82.4 °C | ASTM D1078-11(2019) |
| Flash point, closed cup | 12 °C | ASTM D56-21a |
| Dynamic viscosity at 20 °C | 2.43 mPa·s | ASTM D445-21 with density conversion |
| Surface tension at 20 °C | 21.7 mN/m | ASTM D1331-20 |
| Water content | ≤0.10 wt% | ASTM E1064-22 or USP 921 Method Ia |
| Acidity as acetic acid | ≤0.002 wt% | ASTM D1613-17 |
| Non-volatile residue | ≤0.001 wt% | ASTM D1353-13(2021) |
For printed circuit board defluxing, 2-propanol is specified at ≥99.9% purity with water below 100 ppm and trace metal concentrations in the low nanograms per gram range. Electronic-grade acceptance criteria are addressed in SEMI C41-0705, which defines limits for chloride, sulfate, particles, and metallic impurities. In spray-under-immersion cleaners fitted with megasonic transducers, 2-propanol reduces surface tension and displaces submicrometer particles from low-standoff-height components. A commonly evaluated process uses a 70:30 v/v 2-propanol/water blend at 40–50 °C, but the exact ratio must be validated against the solder flux chemistry and the board surface finish. Ionic contamination is then verified per IPC TM-650 2.3.25 or the workmanship criteria of ANSI/J-STD-001. When water content in the solvent blend exceeds 0.50%, drying time increases and the risk of ionic residue at the component lead-to-solder interface becomes measurable in the conductivity test. This is a critical threshold because moisture-residue entrapment under low-standoff ball-grid arrays is not visually detectable.
When the GHS Label and Packing Certificate Diverge in Transport Documentation
The GHS label addresses workplace hazard communication; the packing certificate addresses the performance-tested package under transport law. A GHS label for 2-propanol bears the flame pictogram, the exclamation mark pictogram, the signal word “Danger,” and the hazard statements H225, H319, and H336. It also carries precautionary statements for fire prevention, eye protection, ventilation, and response. The packing certificate records that the outer package conforms to a UN performance-tested packaging specification, such as a 4G fibreboard box or a 1A1 steel drum, and that the closure meets the applicable drop, stack, and leakproofness criteria under the UN Model Regulations. The certificate references the proper shipping name, which may appear as “Isopropanol” or “Isopropyl alcohol,” and the classification UN 1219, Class 3, Packing Group II.
A documentation conflict can occur when a GHS label is applied to an inner bottle, but the outer package carries the transport hazard label under ADR section 5.2.2 or IMDG Code part 5.2. The workplace GHS label and the transport hazard label are not interchangeable. The packing certificate may cover multiple inner receptacles in one outer package, while the GHS label is required on each immediate container. Receiving inspectors therefore compare the UN specification marking on the outer package with the packing certificate number, but they do not assume that a GHS label alone satisfies transport labeling duties. For air shipment, the maximum net quantity must be verified against the current IATA Dangerous Goods Regulations packing instruction for UN 1219; published data for this specific configuration is limited if the mode of carriage is not stated on the certificate.
In pharmaceutical manufacturing, 2-propanol is a Class 3 residual solvent under ICH Q3C, with a permitted daily exposure of 50 mg/day and a default concentration limit of 5000 ppm in the drug product unless otherwise justified. Equipment cleaning after crystallization or tablet wet-massing is therefore monitored by swab testing and headspace gas chromatography per USP 467. The cleaning acceptance limit is not derived from the PDE of 2-propanol alone; it is based on the active pharmaceutical ingredient, its cleanup difficulty, and the transfer limit from shared equipment. Oxidation of 2-propanol to acetone during storage or drying is detectable by GC at 0.05–0.1 area% when headspace conditions are improperly purged. This is an operational boundary for drying vessels where residual oxygen and elevated jacket temperatures accelerate the oxidation pathway.
As a disinfectant active substance, 2-propanol demonstrates rapid bactericidal activity in the range of 60–70 vol% in water. Quantitative suspension testing under EN 1276 requires a log reduction ≥5 within 60 s for the defined bacterial strains. The mechanism is cytoplasmic membrane disruption and denaturation of membrane and intracellular proteins. Concentrations above 91 vol% show reduced efficacy because water is required for protein denaturation. Bacterial spores are not reliably inactivated; sporicidal claims require separate validation under EN 17126. The TDS does not provide antimicrobial performance data, and the SDS does not authorize biocidal claims. A disinfectant formulation marketed in the European Economic Area must be supported by a product authorization dossier under EU Biocidal Products Regulation (EU) No 528/2012.
On receipt, the packing certificate is compared with the UN marking on the container and outer package. The COA lot number is linked to the production lot, while the packing certificate number is linked to the packaging lot; they are not required to be identical. Traceability is therefore maintained through the bill of lading and the supplier’s document transmittal, not through a single identifier. Storage quantity limits for 2-propanol in indoor processing areas are governed by 29 CFR 1910.106 and the applicable chapter of NFPA 30. Transfer from drums should be performed with electrically conductive hoses and verified bonding, because vapor release from the 12 °C closed-cup flash point material can form an ignitable mixture near the container opening even at ambient temperature.