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ICH Q6B Test Procedures And Acceptance Criteria For Biophysical Characterization
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ICH Q6B is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It focuses on the specification of test procedures and acceptance criteria for biotechnological/biological products. Accepted by FDA, EMeA, and Japanese regulatory agencies, this guideline details standards for biotechnological/biological products, including composition determination, physical properties, and structure of the therapeutic protein.
| ICH Q6B Compliance Criteria | |
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| Structural Characterization and Confirmation: |
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| Physicochemical Properties: |
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| Impurities: |
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Testing Procedures
CovalX provides comprehensive solutions for characterizing products in alignment with the ICH Q6B quality guidelines required for IND submission. Explore our offerings: