Definition
ChEBI: Tributyl citrate is a carbonyl compound.
Production Methods
Tributyl citrate is prepared by the esterification of citric acid with
butanol.
General Description
Tributyl citrate is an ester of citric acid. It is used to plasticize polymers for coating solid drug dosage forms, tablets and capsules.
Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards.
Pharmaceutical Applications
Tributyl citrate is used to plasticize polymers in formulated
pharmaceutical coatings. The coating applications include capsules,
tablets, beads, and granules for taste masking, immediate release,
sustained-release, and enteric formulations.
Safety
Tributyl citrate is used in oral pharmaceutical formulations. It is
generally regarded as an essentially nontoxic and nonirritating
material. However, ingestion of large quantities may be harmful.
LD50 (cat, oral): >50 mL/kg
LD50 (mouse, IP): 2.9 g/kg
LD50 (rat, oral): >30 mL/kg
storage
Tributyl citrate should be stored in well-closed containers in a cool,
dry location at temperatures not exceeding 38℃. When stored in
accordance with these conditions, tributyl citrate is a stable
material.
Incompatibilities
Tributyl citrate is incompatible with strong alkalis and oxidizing
materials.
Regulatory Status
Approved in the USA for indirect food contact in food films.
Included in the Canadian List of Acceptable Non-medicinal
Ingredients.