FD & C Yellow 5 Lake
FD&C Yellow 5 Lake is a water-insoluble form of the synthetic food and pharmaceutical colorant Yellow 5 (Tartrazine), widely used to impart yellow color to tablets, capsules, and other solid dosage forms in the pharmaceutical industry. It is preferred in solid formulations due to its stability and reduced solubility compared to the water-soluble dye.
🏭⚗️ Production
FD&C Yellow 5 Lake is produced by precipitating Tartrazine with aluminum or calcium salts, forming an insoluble pigment known as a “lake.” The manufacturing process involves controlled pH conditions and careful addition of the metal salts to ensure uniform particle size and consistent color strength. The resulting pigment is filtered, washed, dried, and milled to the desired fineness suitable for pharmaceutical applications.
🔬 Properties
FD&C Yellow 5 Lake is a fine, yellow, free-flowing powder with excellent dispersibility in water-insoluble media. It is stable under heat, light, and acidic conditions, making it suitable for use in tablets, capsules, and coated formulations. The lake form reduces migration of color within solid dosage forms and provides a uniform, bright yellow appearance. Its chemical composition ensures non-reactivity with most excipients.
🧪 Applications
FD&C Yellow 5 Lake is used extensively in pharmaceutical and nutraceutical products to provide consistent yellow coloring in tablets, capsules, lozenges, and confectionery. It is also employed in cosmetics for coloring powders and other solid formulations. In analytical laboratories, it may serve as a reference standard for color consistency and quality control.
⚠️ Safety
FD&C Yellow 5 Lake is approved for use in food, drugs, and cosmetics by regulatory authorities such as the FDA. However, some individuals may exhibit sensitivity or allergic reactions to Tartrazine, including hyperactivity or mild skin reactions. Proper storage involves keeping the pigment in a dry, cool environment, away from light and moisture to preserve color stability. Handling should avoid inhalation of dust; personal protective equipment such as gloves and masks is recommended in industrial or laboratory settings.
