Acetyl tributyl citrate

Chemical properties

clear colorless liquid

Chemical properties

Acetyltributyl citrate is a clear, odorless, practically colorless, oily liquid.

Chemical properties

Tributyl acetylcitrate has a very faint, sweet, herbaceous odor. At high levels (e.g., 1000 ppm emulsion in water), it has a mild, fruity, nondescript flavor.

Chemical properties

Acetyl tributyl citrate (ATBC) is a colorless, odorless liquid. Its water solubility is less than 0.002 g/100 mL, but it is soluble in organic solvents.

The Uses of Acetyl tributyl citrate

Labelled Tributyl O-Acetylcitrate (T772950). Topical pharmaceutical formulation anesthetic surfactant ester.

The Uses of Acetyl tributyl citrate

plasticizer flavoring agent

The Uses of Acetyl tributyl citrate

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Definition

Aqueous-based pharmaceutical coat- ings.

Production Methods

Acetyltributyl citrate is prepared by the esterification of citric acid with butanol followed by acylation with acetic anhydride.

Preparation

From citric acid via the tributyl ester followed by acetylation.

Taste threshold values

An emulsion of the title material in water at 1000 ppm has only a very faint, mildly fruity-winey, berry-like odor and a mild, nondescript taste.

General Description

Tributyl 2-acetylcitrate is a hydrophobic biodegradable plasticizer, that is usually synthesized by esterification of citric acid. Pharmaceutically, it is used as an excipient, which is generally applied as a thin film over the tablets or capsules.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Pharmaceutical Applications

Acetyltributyl citrate is used to plasticize polymers in formulated pharmaceutical coatings, including capsules, tablets, beads, and granules for taste masking, immediate release, sustained-release and enteric formulations.

Safety Profile

When heated to decomposition it emits acrid smoke and irritating fumes. ADD750

Safety

and films intended for direct food contact. It is also used in selfadhesive thin films used for topical delivery systems. It is generally regarded as a relatively nontoxic and nonirritating material. However, ingestion of large quantities may be harmful.
LD₅₀ (cat, oral): >50 mL/kg
LD₅₀ (mouse, IP): >4 g/kg
LD₅₀ (rat, oral): >31.5 g/kg

Carcinogenicity

The chronic toxicity of ATBC was evaluated in rats fed diets containing 200, 2000, or 20,000 ppm of ATBC for 2 years. There were no treatment- related lesions in any organs examined.

Solubility in organics

Miscible with alcohol and oils.

storage

Acetyltributyl citrate should be stored in a well-closed container in a cool, dry location at temperatures not exceeding 38℃. When stored in accordance with these conditions, acetyltributyl citrate is a stable product.

Incompatibilities

Acetyltributyl citrate is incompatible with strong alkalis and oxidizing materials.

Regulatory Status

Included in FDA Inactive Ingredients Database (oral capsules and tablets). Included in nonparenteral medicines licensed in the UK. Approved in the USA for direct food contact in food films.