" /> Process Related Impurity - CISMeF





Preferred Label : Process Related Impurity;

NCIt related terms : Process Related/Process;

NCIt definition : Impurities that are derived from the manufacturing process. They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing reagents or column leachables), or starting materials.;

Alternative definition : PQCMC: Impurities that are derived from the manufacturing process. [Source: SME Defined] Examples: Small molecules -- starting materials, intermediates, antibiotics, or media components, by-products, etc. Large molecules -- They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing reagents or resin leachables).;

NCI Metathesaurus CUI : CL1642623;

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27/07/2025


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