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Carnauba Wax Excipient | Uses, Suppliers, and Specifications
Carnauba Wax, sometimes referred to as Brazil wax or Palm wax, is a wax obtained from the leaves of the Carnauba palm (Copernicia prunifera, Mill), a plant native to Brazil. The wax is chemically complex and consists of various fatty acid esters (80-85%), fatty alcohols (10-16%), acids (3-6%), and hydrocarbons (1-3%). It is supplied as a light brown-to pale yellow-coloured powder, flakes, or lumps (graded Type 1, 3 and 4, depending on quality) and characterised by having a bland odour and practically no taste.
Synonyms and Trade Names: Carnauba Wax; Brazil Wax; Palm Wax; E903; Cera Carnuba; Cerapharm® Carnauba Wax; SP63 Carnauba Wax
Pharmacopoeial Compliance: USP-NF; Ph. Eur; JP; IP
Uses and Applications: Stiffening Agent and Wax
Carnauba Wax SP-63 (No. 1) Yellow Type 1 - Strahl & Pitsch
Description
Carnauba is a wax derived from the leaves of a plant native to northeastern Brazil, the carnauba palm (Copernicia prunifera). It is sometimes referred to as the “queen of waxes” and usually occurs in the form of hard yellow-brown flakes. In order to extract the wax, workers collect the leaves of the carnauba palm and beat them to loosen the wax, which is subsequently refined and/or bleached into the desired grade.
From a composition point of view, Carnauba wax is complex. It contains esters of fatty acids (80-85%), fatty alcohols (10-15%), acids (3-6%) and hydrocarbons (1-3%). A unique feature of Carnauba wax is the content of esterified fatty diols (approx. 20%), hydroxylated fatty acids (about 6%) and cinnamic acid (about 10%). Cinnamic acid, which has antioxidant properties, may be present in hydroxylated or methoxylated forms.
Carnauba wax is supplied in the form of a light brown-to pale yellow-coloured material, which can be in the form of a powder, flakes, or irregular lumps of hard, brittle wax. It exhibits a characteristic bland odour and has no taste and is free from rancidity. Commercial grades are usually classified into three classes, designated Type 1, Type 3 and Type 4, depending on purity levels. Type 1 is the type most commonly used in pharmaceutical products.
Chemical Structure & Identifiers
| CAS Registry Number | [8015-86-9] |
| Empirical Formula | – |
| Molecular Weight | – |
| EC/EINECS Number | 232-399-4 |
| UNII Code (FDA) | R12CBM0EIZ |
Regulatory Status
Carnauba wax is an approved pharmaceutical excipient, cosmetic ingredient and food additive. It is widely used in oral and topical pharmaceutical products, cosmetic formulations, and several food products. Carnauba wax is GRAS listed and authorised for use as a food additive in Europe (E903). It is also included in the US FDA Inactive Ingredients Database (covering oral capsules and tablets).
Physicochemical Properties
| Form | Solid |
| Appearance | Yellowish powder or flakes |
| Acid value | 2-7 |
| Saponification value | 78-95 |
| Relative Density | 0.990-0.999 |
| Melting point | 81-86 oC |
| Flashpoint | 270-530 oC |
| Refractive index | 1.450 |
| Solubility | Slightly soluble in boiling ethanol (95%); practically insoluble in water |
| Unsaponified matter | 50-55% |
Pharmacopeoeal Specifications
| USP-NF | PhEur | JP | |
| Name | Carnauba Wax | Carnauba Wax | Carnauba Wax |
| Definition | specified | specified | specified |
| Authorised use | Excipient | Excipient | Excipient |
| Characters | n/a | specified | specified |
| Identification | n/a | specified | n/a |
| Appearance of solution | n/a | specified | n/a |
| Melting range | 80 – 86 oC | 80 – 88 oC | 80 – 86 oC |
| Acid value | 2 – 7 | 2 – 7 | 10.0 |
| Saponification value | 78 – 95 | 78 – 95 | 78 – 95 |
| Total ash | ≤0.25% | ≤0.25% | n/a |
| Heavy metals | ≤20 µg/g | n/a | n/a |
| Iodine value | n/a | n/a | 5 – 14 |
| Specific gravity | n/a | n/a | 0.990 – 1.002 |
| Assay | n/a | n/a | n/a |
| Labelling | specified | n/a | n/a |
Key: n/a Specification is not listed
*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.
Applications in Pharmaceutical Formulations or Technology
Carnauba wax is used in pharmaceutical products, cosmetics and some food formulations due to its water-repelling features. In topical products, such as lip balms and other topical products, Carnauba wax is added to impart a hard consistency to the product.
Carnauba wax is used to add a glossy finish to substrates, and as such is used in waxes and polishes. Being one of the hardest and highest-melting of the natural waxes that are commercially available, it is used alone or mixed with beeswax as a coating on dental floss or added to tablet film coating formulas. For instance, a 10% w/v aqueous emulsion is used to polish sugar-coated tablets (glossing agent). Carnauba wax (10-50% w/w) is also used alone or with Hypromellose, Hydroxypropyl cellulose, Alginate/ pectin-gelatine, Methacrylic acid methacrylate copolymers (Eudragit®), and Stearyl alcohol to design sustained-release solid-dosage forms.
In cosmetic products, Carnauba wax is a widely accepted ingredient and can be found in lipsticks, eyeliners, mascara, eye shadows, foundations, blushers, skincare preparations, and sun care preparations. In food products, it is used as a formulation aid, lubricant, release agent, anticaking agent, and surface finishing agent in baked foods and mixes, chewing gum, confections, frostings, fresh fruits and juices, gravies, sauces, processed fruits and juices, soft candy and TicTacs.
Safety and Precautions
Carnauba wax is considered a nontoxic and non-irritating material. The US FDA considers Carnuaba wax as Generally Recognized As Safe (GRAS) both a direct and indirect food additive. However, incidences of allergic contact dermatitis from carnauba wax in mascara have been reported. The World Health Organisation has determined that an acceptable daily intake (ADI) for Carnauba wax is up to 7 mg/kg body-weight.
Stability and Storage Conditions
Carnauba wax is a stable excipient. The assigned shelf-life is 24-36 months. The materials is recommended to be stored in a well-closed container, in a cool, dry place. When handling Carnauba wax, workers should observe normal precautions appropriate to the circumstances and quantity of material processed.
Sustainability and Environmental Impact
A sustainability assessment of Carnauba wax has not been computed. However, being a natural material, the impact on the ecology and marine life is not expected to be adverse. There may well be environmental and social concerns arising from Carnauba wax harvesting practices in northeast Brazil, including high rates of deforestation and degradation of local biodiversity, as well as poor working conditions and low pay for workers involved in the supply chain.
Manufacturers & Suppliers
- Carnauba Wax
- Kahl Carnauba Wax
- Carnauba Wax
- Cerapharm® Carnauba Wax
- EWACERA® 34 Carnauba Wax
Additional Resources (Downloads)
References and Literature Used
FAQS
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