Acetyl tributyl citrate

Химические свойства

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.

Использование

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

Определение

Aqueous-based pharmaceutical coat- ings.

Подготовка

From citric acid via the tributyl ester followed by acetylation.

Методы производства

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

Пороговые значения вкуса

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.

Общее описание

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.

Фармацевтические приложения

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.

Профиль безопасности

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

Безопасность

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

Канцерогенность

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.

хранилище

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.

Несовместимости

Acetyltributyl citrate is incompatible with strong alkalis and oxidizing materials.

Регуляторный статус

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.