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General chapter 5.1.13. Pyrogenicity does not recommend LAL-based methods (general chapter 2.6.14) over the rFC-based method (previously general chapter 2.6.32, in general chapter 2.6.14 as of Issue 13.1) or vice versa. Users are responsible for selecting the most appropriate method based on risk assessment and their assessment of the potential presence of pyrogens. General chapter 5.1.13 (Issue 13.1, publication date of April 2026, with an implementation date of 1 January 2027) also mentions: “Considerations regarding sustainability should be made when choosing a method (A-G) for the test for bacterial endotoxins in general chapter 2.6.14. Bacterial endotoxins.” It is the user’s responsibility to decide on a testing strategy and limits.

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