Transcription of 232 ELEMENTAL IMPURITIES—LIMITS - United States …
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232 ELEMENTAL IMPURITIES LIMITSINTRODUCTIONThis general chapter specifies limits for the amounts of ELEMENTAL impurities in drug products. ELEMENTAL impurities includecatalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These impuri-ties may occur naturally, be added intentionally, or be introduced inadvertently ( , by interactions with processing equip-ment and the container closure system). When ELEMENTAL impurities are known to be present, have been added, or have thepotential for introduction, assurance of compliance to the specified levels is required.
USP 39 Chemical Tests / á232ñ Elemental Impurities—Limits 1 tice, may exceed 2 L (e.g., saline, dextrose, TPNs, solutions for irrigation), a 2-L volume may be used to calculate permissible concentrations from PDEs.
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