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Isopropyl alcohol
ایزوپروپیل الکل، ایزوپروپانول
1Nonproprietary names
- BPIsopropyl Alcohol
- JPIsopropanol
- Ph. Eur.Isopropyl Alcohol
- USP–NFIsopropyl Alcohol
2Synonyms and trade names
Dimethyl carbinol; IPA; isopropanol; 2-propanol; propan-2-ol; sec-propyl alcohol; rubbing alcohol
3Chemical name and CAS Registry Number
Propan-2-ol · [67-63-0]
UNII ND2M416302 · PubChem CID 3776
4Empirical formula and molecular weight
C3H8O · 60.10
5Functional category
Solvent, humectant
Typical concentrations: — · Dosage forms: Solid, Semi-solid
6Applications in pharmaceutical formulation
Used as a solvent in tablet film coating and wet granulation, where it is removed during drying, and as a solvent and penetration-modifying component in topical products. In aqueous solution at about 60–70% v/v it is an effective skin and surface disinfectant and is widely used in hand rubs and swabs. It is also used in the extraction and crystallisation of drugs and excipients.
7Description
A clear, colourless, mobile, volatile and flammable liquid with a characteristic spirit-like odour and a slightly bitter taste.
8Typical properties
- Boiling point
- ≈ 82.4 °C
- Melting point
- ≈ −89.5 °C
- Density
- ≈ 0.786 g/cm³ at 20 °C
- Flash point
- ≈ 12 °C (closed cup)
- Refractive index
- ≈ 1.377 at 20 °C
- Solubility
- miscible with water, ethanol, ether, chloroform and glycerin; forms an azeotrope with water (about 88% w/w)
9Stability and storage conditions
Store in an airtight container in a cool, well-ventilated place away from sources of ignition. On prolonged storage, particularly in contact with air and light, peroxides may form.
10Incompatibilities
Incompatible with strong oxidising agents such as hydrogen peroxide and nitric acid. It can be salted out of aqueous mixtures by electrolytes such as sodium chloride and sodium sulfate.
11Method of manufacture
Produced mainly by hydration of propene, either indirectly via sulfuric acid or directly over an acidic catalyst, and to a lesser extent by catalytic hydrogenation of acetone. It is purified by distillation.
12Safety
Ingestion or substantial inhalation causes central nervous system depression and gastrointestinal irritation; it is more toxic than ethanol and is metabolised to acetone. Repeated application to the skin causes drying and irritation, and significant absorption through the skin can occur in infants. It must not be used in oral products other than as a processing solvent that is removed.
13Handling precautions
Highly flammable. Use in a well-ventilated area or with local exhaust, keep away from ignition sources, use explosion-protected equipment and earthing, and wear eye protection and gloves.
14Regulatory status
Included in the FDA Inactive Ingredient Database (oral capsules and tablets as a processing solvent; topical preparations) and in non-parenteral medicines licensed in Europe. Classified by ICH Q3C as a class 3 residual solvent (low toxic potential; residues up to 5000 ppm acceptable without justification).
15Related substances
Ethanol; propan-1-ol (propyl alcohol); acetone.
16Comments
For skin disinfection, concentrations of about 60–70% v/v are more effective than the neat alcohol because water is needed for protein denaturation. Residual solvent levels in coated or granulated products should be controlled by validated drying and tested by gas chromatography.