The development of analytical methodology for potential genotoxic impurities (GTIs) assessment can be time consuming and laborious. While there are several approaches to method development, having a discussion forum to discuss challenges and best practices can help streamline the evaluations. This ‘Confirmatory Testing’ category provides a forum for: 1) Asking lots of questions; 2) Share your work, 3) Give plenty of feedback.
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This Community is for informational and discussion purposes only and does not reflect USP’s or its Expert Committee’s opinions on future development or revisions to official text of the USP–NF. USP-NF standards are developed through USP’s development process and are outside the scope of this Community. USP is under no obligation to incorporate or rely on information in this Community for standards development purposes