usp_233LeafLevel 2
<233> Elemental Impurities - Procedures
USP Chapter <233> defines the procedures for determining elemental impurities in drug substances and products, specifying testing methods, acceptance criteria and limits based on daily exposure thresholds. It guides the use of techniques such as ICP-MS or AAS and outlines steps for sample preparation, analysis, and reporting to ensure compliance with safety standards.
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