Friday, 17 July 2009

Monographs: Pharmaceutical substances: Cera carnauba - Carnauba wax

Chemical name. Carnauba wax; CAS Reg. No. 8015-86-9.

Description. Pale yellow to light brown, moderately coarse powder, flakes, or irregular lumps of hard, brittle wax; odour, characteristic and free from rancidity.

Solubility. Practically insoluble in water; soluble in toluene R; slightly soluble in boiling ethanol (~750 g/l) TS.

Category. Polishing agent for coated tablets; viscosity-increasing agent for ointments; release-rate modifier for oral formulations.

Storage. Carnauba wax should be kept in a well-closed container.


Definition. Carnauba wax is obtained from the leaves of Copernicia cerifera Mart. (Fam. Palmae).

Melting range. 78-85 °C.

Ash. Weigh 2.0 g and use an open porcelain or platinum dish. Heat over a flame; it volatilizes without emitting an acrid odour. Ignite; the residue weighs not more than 2.5 mg/g.

Acid value. Use 3 g; not more than 8.

Saponification value. Use about 3 g, accurately weighed, add 25 ml of xylene R, and dissolve by warming. To this solution add 50 ml of ethanol (~750 g/l) TS and proceed with the determination of saponification. Attach a reflux condenser and heat for 2 hours; 75-95.

Iodine value. 5-14.

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