International Numbering System (INS) for Food Additives: 304
Food additives Europe numbers: E304
Functional Category
Antioxidant
Applications in Pharmaceutical Formulation
Ascorbyl palmitate is primarily used either alone or in combination with alpha tocopherol as a stabilizer for oils in oral pharmaceutical formulations and food products; generally 0.05% w/v is used. It may also be used in oral and topical preparations as an antioxidant for drugs unstable to oxygen. The combination of ascorbyl palmitate with alpha tocopherol shows marked synergism, which increases the effect of the components and allows the amount used to be reduced. The solubility of ascorbyl palmitate in alcohol permits it to be used in nonaqueous and aqueous systems and emulsions.
Description
Ascorbyl palmitate is a practically odorless, white to yellowish powder.
Stability and Storage Conditions
Ascorbyl palmitate is stable in the dry state, but is gradually oxidized and becomes discolored when exposed to light and high humidity. In an unopened container, stored in a cool place, it has a shelf life of at least 12 months. During processing, temperatures greater than 658C should be avoided. The bulk material should be stored in an airtight container at 8–158C, protected from light
Incompatibilities
Incompatibilities are known with oxidizing agents; e.g. in solution oxidation is catalyzed by trace metal ions such as Cu2þ and Fe3þ.
Safety
Ascorbyl palmitate is used in oral pharmaceutical formulations and food products, and is generally regarded as an essentially nontoxic and nonirritant material. The WHO has set an estimated acceptable daily intake for ascorbyl palmitate at up to 1.25 mg/kg bodyweight.(2) LD50 (mouse, oral): 25 g/kg(3) LD50 (rat, oral): 10 g/kg