Ｏアセチルクエン酸 トリブチル

外観

無色～うすい黄色透明液体

定義

本品は、アセチル化したクエン酸(*)とブタノール(*)とのトリエステルであり、次の化学式で表される。
参照表示名称：クエン酸, ブタノール

用途

アセチルクエン酸トリブチル（ATBC）は、塩化ビニル樹脂などの可塑剤として低毒性であり、食品包装用に最適です。加工性も良好です。

化粧品の成分用途

可塑剤、香料

化学的特性

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.

使用

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

定義

Aqueous-based pharmaceutical coat- ings.

製造方法

From citric acid via the tributyl ester followed by acetylation.

調製方法

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

一般的な説明

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.

応用例（製薬）

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.

安全性プロファイル

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

安全性

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

発がん性

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.

貯蔵

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.

不和合性

Acetyltributyl citrate is incompatible with strong alkalis and oxidizing materials.

規制状況(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.