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Excipient monograph · مونوگراف ماده جانبی
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Wax, carnauba
موم کارنوبا
1Nonproprietary names
- BPCarnauba Wax
- JPCarnauba Wax
- Ph. Eur.Carnauba Wax
- USP–NFCarnauba Wax
2Synonyms and trade names
Brazil wax; caranda wax; cera carnauba; palm wax; E903
3Chemical name and CAS Registry Number
Wax obtained from the leaves of Copernicia cerifera (Copernicia prunifera) · [8015-86-9]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Coating agent, film former
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used mainly as a polishing agent for sugar-coated and film-coated tablets, applied in very small amounts as a fine powder or as a solution or emulsion, to give a glossy finish. It is also used in controlled-release matrices and melt-processed products, as a stiffener in topical preparations and cosmetics such as lipsticks, and as a glazing agent in foods.
7Description
Light brown to pale yellow powder, flakes or irregular lumps of hard, brittle wax with a characteristic bland odour and practically no taste. It consists mainly of esters of long-chain fatty acids and fatty alcohols, with free acids, alcohols, hydrocarbons and resins.
8Typical properties
- Melting range
- about 80–88 °C
- Acid value
- 2–7
- Saponification value
- about 78–95
- Solubility
- soluble in warm chloroform and warm toluene; slightly soluble in boiling ethanol (95%); practically insoluble in water
- Hardness
- one of the hardest natural waxes; brittle at room temperature
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents.
11Method of manufacture
The leaves of the Brazilian carnauba palm are cut and dried, and the wax that forms on their surface is beaten off, melted, strained and refined; it may be bleached.
12Safety
Used in oral pharmaceuticals, foods and cosmetics and regarded as essentially non-toxic and non-irritant. Rare cases of contact allergy have been reported from cosmetic use.
13Handling precautions
Observe normal precautions for the quantity handled. Take care with hot molten wax; eye protection is recommended.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E903). Included in the FDA Inactive Ingredient Database (oral capsules and tablets) and in non-parenteral medicines licensed in Europe.
15Related substances
Wax, microcrystalline; wax, white; wax, yellow; candelilla wax.
16Comments
For polishing, a small amount of powdered wax is tumbled with warm, dry coated tablets in a polishing pan; using too much wax gives a dull, patchy surface. Its high melting point makes it useful for raising the melting point and hardness of softer wax blends.