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Impurities within pharmaceuticals can be thought of as unwelcome companions that accompany the primary active ingredients. They can originate during the manufacturing process, formulation, or even emerge as a product ages. These impurities can significantly affect the purity and overall quality of both the drug substance and the final product intended for patients' use. Regulatory bodies are actively working to provide precise definitions and guidelines to ensure the safety and efficacy of pharmaceuticals for the well-being of patients. If you have any further questions or topics you'd like to delve into, please feel free to ask. An impurity in the context of pharmaceuticals refers to any substance found in the drug substance (bulk material) or the final drug product (in its container) that is not the specified chemical entity of the drug substance, an excipient, or any other additives intentionally included in the drug product. Impurities in pharmaceuticals can manifest as unwanted chemical compounds that either persist within the Active Pharmaceutical Ingredients (APIs) or arise during the formulation process or with the passage of time, affecting both the APIs and the formulated medicines. Some key analytical methods employed to identify and quantify these impurities include Thin Layer Chromatography (TLC) and spectroscopy. These techniques are crucial for ensuring the quality and safety of pharmaceutical products.