Name: Acetyltributyl Citrate
CAS No: 1,2,3-Propanetricarboxylic acid, 2-acetyloxy, tributyl ester [77-90-7]
USP-NF: Acetyltributyl Citrate PhEur: Tributyl Acetylcitrate
Acetylbutyl citrate; acetylcitric acid, tributyl ester; ATBC; Citroflex A-4; tributyl acetylcitrate; tributylis acetylcitras; tributyl Oacetylcitrate; tributyl citrate acetate.
1,2,3-Propanetricarboxylic acid, 2-acetyloxy, tributyl ester [77-90-7]
C20H34O8 402.5
Acetyltributyl citrate is used to plasticize polymers in formulated pharmaceutical coatings,(1–5) including capsules, tablets, beads, and granules for taste masking, immediate release, sustained-release and enteric formulations.
Acetyltributyl citrate is a clear, odorless, practically colorless, oily liquid.
See Table I.
Acid value 0.02 Boiling point 3268C (decomposes) Flash point 2048C Pour point 598C Solubility Miscible with acetone, ethanol, and vegetable oil; practically insoluble in water. Viscosity (dynamic) 33 mPa s (33 cP) at 258C
Acetyltributyl citrate should be stored in a well-closed container in a cool, dry location at temperatures not exceeding 388C. When stored in accordance with these conditions, acetyltributyl citrate is a stable product.
Acetyltributyl citrate is incompatible with strong alkalis and oxidizing materials.
Acetyltributyl citrate is prepared by the esterification of citric acid with butanol followed by acylation with acetic anhydride.
Acetyltributyl citrate is used in oral pharmaceutical formulations and films intended for direct food contact. It is also used in selfadhesive thin films used for topical delivery systems.(6) 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(7) LD50 (mouse, IP): >4 g/kg LD50 (rat, oral): >31.5 g/kg
Observe normal precautions appropriate to the circumstances and quantity of material handled. Acetyltributyl citrate is slightly irritating to the eyes and may be irritating to the respiratory system as a mist or at elevated temperatures. Gloves and eye protection are recommended for normal handling, and a respirator is recommended when using acetyltributyl citrate at elevated temperatures.
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.
Acetyltriethyl citrate; tributyl citrate; triethyl citrate.
Acetyltributyl citrate is used as a plasticizer in food contact films, although it has been known to migrate from food-grade PVC films into high-fat foods such as olive oil.(8) Polylactide plasticized with acetyltributyl citrate has been investigated as a biodegradable barrier for use in guided-tissue regeneration therapy.(9) The EINECS number for acetyltributyl citrate is 201-067-0. The PubChem Compound ID (CID) for acetyltributyl citrate is 6505.