This medical-grade stearic acid offers ultra-high purity of 99.8% minimum, with extremely low residual solvents and heavy metal content to meet the strictest pharmaceutical standards. It delivers excellent lubrication and gliding performance, improving tablet press yield by reducing powder sticking and machine downtime. It is non-irritating to human tissue, compatible with most pharmaceutical excipients, and can be used as a coating agent for hard capsules and a thickener for topical ointments. The product is available in sterile grade for sensitive medical applications, with a 36-month shelf life when stored properly, helping pharmaceutical enterprises reduce production waste and ensure consistent product quality.
Product Specifications include minimum 99.8% purity, melting point of 70-72°C, acid value ranging from 200-210 mgKOH/g, iodine value limited to max 0.3 gI₂/100g, residual solvents capped at 0.01%, heavy metals (as Pb) under 5 ppm, arsenic content max 2 ppm. It is packaged in 20-kilogram GMP-compliant glass fiber drums, with particle size of minimum 300 mesh. The product meets USP 39 and EP 9.0 pharmacopoeia standards, and has a 36-month shelf life when stored in a cool, dry environment. Sterile grade options are available for vaccines and sterile medical device manufacturing.
Medical Excipient Grade Stearic Acid is widely used in multiple pharmaceutical and medical device manufacturing scenarios. It acts as a lubricant for oral tablet pressing, reducing friction and improving the uniformity of tablet formulations. It serves as a coating agent for hard capsule shells, improving their durability and appearance. For topical ointments and creams, it acts as a texture thickener to improve product consistency and application feel. It is also used as a mold release agent for medical device production, preventing parts from sticking to manufacturing molds, and as a carrier material for vaccine adjuvants to improve immune response efficiency.
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