Aluminum Oxide

Basic Information

Name: Aluminum Oxide

CAS No: Aluminum oxide [1344-28-1]

Functional Categories

Adsorbent Dispersing agent

1. Nonproprietary Names

None adopted.

2. Synonyms

Activated alumina; activated aluminum oxide; alpha aluminum oxide; alumina; alumina, calcined; alumina, tabular; aluminum oxide alumite; aluminum trioxide; gamma aluminum oxide

3. Chemical Name & CAS Registry

Aluminum oxide [1344-28-1]

4. Empirical Formula & Molecular Weight

Al2O3 101.96

5. Structural Formula

Aluminum oxide occurs naturally as the minerals bauxite, bayerite, boehmite, corundum, diaspore, and gibbsite.

6. Applications

Aluminum oxide is used mainly in tablet formulations.(1) It is used for decoloring powders and is particularly widely used in antibiotic formulations. It is also used in suppositories, pessaries, and urethral inserts. Hydrated aluminum oxide (see Section 18) is used in mordant dyeing to make lake pigments, in cosmetics, and therapeutically as an antacid.

7. Description

Aluminum oxide occurs as a white crystalline powder. Aluminum oxide occurs as two crystalline forms: a-aluminum oxide is composed of colorless hexagonal crystals, and g-aluminum oxide is composed of minute colorless cubic crystals that are transformed to the a-form at high temperatures.

8. Pharmacopeial Specifications

See Section 18.

9. Typical Properties

Boiling point 29778C Density (bulk) 0.91.1 g/cm3 Flammability Nonflammable. Hardness (Mohs) 8.8 Hygroscopicity Very hygroscopic. Melting point 20508C Solubility Slowly soluble in aqueous alkaline solutions with the formation of hydroxides; practically insoluble in nonpolar organic solvents, diethyl ether, ethanol (95%), and water. Specific gravity 2.8 (becomes 4.0 at 8008C) Vapor pressure 133.3 Pa at 21588C

10. Stability & Storage

Aluminum oxide should be stored in a well-closed container in a cool, dry, place. It is very hygroscopic.

11. Incompatibilities

Aluminum oxide should be kept well away from water. It is incompatible with strong oxidizers and chlorinated rubber. Aluminum oxide also reacts with chlorine trifluoride, ethylene oxide, sodium nitrate, and vinyl acetate. Exothermic reactions above 2008C with halocarbon vapors produce toxic hydrogen chloride and phosgene fumes.

12. Method of Manufacture

Most of the aluminum oxide produced commercially is obtained by the calcination of aluminum hydroxide.

13. Safety

Aluminum oxide is generally regarded as relatively nontoxic and nonirritant when used as an excipient. Inhalation of finely divided particles may cause lung damage (Shaver’s disease).(2

14. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of the material handled.(3) In the UK, the workplace exposure limits for aluminum oxide are 10 mg/m3 long-term (8- hour TWA) for total inhalable dust and 4 mg/m3 for respirable dust.(4) In the USA, the OSHA limit is 15 mg/m3 total dust, 5 mg/m3 respirable fraction for aluminium oxide.(5)

15. Regulatory Status

Included in the FDA Inactive Ingredients Database (oral tablets and topical sponge). Included in nonparenteral medicines licensed in the UK.

16. Related Substances

17. Comments

A specification for aluminum oxide is included in the Japanese Pharmaceutical Excipients (JPE);(6) see Table I. A specification for light aluminum oxide is also included. The PhEur 6.3 includes a specification for hydrated aluminum oxide that contains the equivalent of 47.0–60.0% of Al2O3. The EINECS number for aluminum oxide is 215-691-6.