Stearic Acid is a long-chain saturated fatty acid widely used in pharmaceutical formulations as an excipient, particularly as a lubricant in tablet manufacturing. It plays a critical role in ensuring consistent tablet quality and manufacturing efficiency. Derived from both plant and animal sources, Stearic Acid must meet stringent purity standards to avoid impurities that may affect drug stability or patient safety. Impurity profiling is essential to detect and control any contaminants that may arise during production or storage. Here are some of its known impurities listed below.
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