USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
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<strong>Monograph</strong> Redesign• Well defined acceptance criteria• Simplify solution preparation instructions• Consistent naming convention (Related Compounds<strong>and</strong> Chrom. Impurities eliminated)• Improved tables <strong>and</strong> descriptions of gradients• Changes in solution descriptions• Complete equations• “No longer a recipe”—assumes technicalknowledge• Longer monographs